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Sarina A. Piha-Paul, MD

Department of Investigational Cancer Therapeutics, Division of Cancer Medicine

About Dr. Sarina A. Piha-Paul

I am an Associate Professor in the Division of Cancer Medicine, Department of Investigational Cancer Therapeutics (Phase I Program) at MD Anderson Cancer Center. I have published more than 124 articles in peer-reviewed journals in oncology including fields of drug development and early phase clinical trials. Our department is unique in that we place an emphasis on molecular characterization of individual patient's tumors with the intent to provide personalized cancer therapy in the phase I setting. Our department currently has over 180 active phase I trials on our priority list of which I am involved. Many of these trials have an emphasis on novel, targeted agents and immunotherapeutic agents. Of these active trials, I am currently the principal investigator of over 20 and, of my colleagues within the department, I have had the largest portfolio of "basket trials" which are trials in which patients are preselected on the molecular features of their tumor, irrespective of the histology. I have an extensive track record of leading successful studies that involve a strong correlative component and collaborating with other investigators from basic sciences and other clinical specialties. I have consistently demonstrated the ability to successfully place patients on clinical trials, manage treatment and toxicities, oversee data collection and analysis, procure samples for correlative studies and report trials results.

Beginning in August of 2012, I became involved in the department’s Phase I Fellowship Program as the Associate Program Director. During this time I was integral in securing a GME funded position in addition to philanthropic funds and educational grants for two other fellowship positions with administrative support. For academic year 2016-2017, we secured an additional GME funded position bringing our total to two GME funded positions. We narrowed our focus to fellow applicants with oncology training (rather than internal medicine training) thus making our program stronger and more competitive. During academic year 2017-2018, I was promoted to Program Director of the Phase I Fellowship Program. I have worked diligently to place graduates in academic and pharmaceutical positions around the world. On a daily basis I am interacting with our fellows, whether in clinic, on inpatient, or in the day-to-day administrative items. I have also had the pleasure of working with our fellows in a research mentor capacity (e.g. protocol development, manuscript development, etc.).

In addition to my work with the fellowship program, I have also pursued the following educational endeavors:

Member of the Committee for MS/PhD in Patient-Based Research/Clinical Science, the University of Texas Graduate School of Biomedical Sciences (GSBS)
Faculty Member, GSBS MS/PhD Program
Member of the MD Anderson’s Medical Oncology Fellowship Steering Committee
Member of the Clinical Education Team
Member of the Faculty Academic Review Committee (FARC)
Co-Director of the Ethics in Clinical Trials Research Course through GSBS
Member of the Graduate Medical Education (GME) Wellness Committee
Program Chair, Clinical Studies Meeting (Journal Club)
Instructor for Human Protocol Research, (GS21 1132) through GSBS

Finally, in an effort to expand my knowledge on the principles and partices of teaching, I have become involved (as of January 2018) in the Health Educators Certification Program which is an 18 month program for which I am a fellow.

Combining immunotherapy with bacterial injection shows promise in treatment-refractory solid tumors

Present Title & Affiliation

Primary Appointment

Professor, Department of The Department of Investigational Cancer Therapeutics, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas

Research Interests

Phase I trial design
Non-invasive imaging biomarkers
Drug development
The molecular basis of cancer

Education & Training

Degree-Granting Education

2010	The University of Texas Graduate School of Biomedical Sciences, Houston, Texas, US, Biomedical Sciences, Master of Science (M.S.)
2002	Louisiana State University Health Sciences Center, New Orleans, Louisiana, US, Medicine, Medical Doctorate (M.D.)
1997	Louisiana State University, Baton Rouge, Louisiana, US, Microbiology, Bachelor of Science (B.S.)

Postgraduate Training

2008-2009	Teaching Chief Fellow, The University of Texas MD Anderson Cancer Center, Houston, Texas
2006-2009	Clinical Fellowship, Hematology and Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas
2005-2006	Chief Medical Resident, Baylor College of Medicine, Houston, Texas
2002-2005	Clinical Residency, Internal Medicine, Baylor College of Medicine, Houston, Texas

Licenses & Certifications

2025	Alabama Board of Medical Examiners
2024	Florida Board of Medicine
2024	Mississippi State Board of Medical Licensure
2024	Georgia Composite Medical Board
2024	Washington State Department of Health
2024	Arizona Board of Medical Examiners
2024	Tennessee Board of Medical Examiners
2024	Oklahoma State Board of Medical Licensure
2024	Louisiana State Board of Medical Examiners
2009	Medical Oncology
2008	Texas Medical Board
2005	Internal Medicine

Experience & Service

Faculty Academic Appointments

Associate Professor, Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, Houston, TX, 2016 - 2024

Assistant Professor, Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, Houston, TX, 2009 - 2016

Administrative Appointments/Responsibilities

Cancer Center Support Grant (CCSG) Research Program Member, The University of Texas, MD Anderson Cancer Center, Houston, Texas, 2025 - Present

Chair for Non-Standard Graduate Education Programs, Department of Office of Graduate Medical Education (OGME), The University of Texas, MD Anderson Cancer Center, Houston, Texas, 2025 - Present

Cancer Center Support Grant (CCSG) Research Program Member, The University of Texas, MD Anderson Cancer Center, Houston, Texas, 2024 - 2024

Texas Medical Board Liaison, Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, Houston, Texas, 2021 - 2025

Fellowship Program Director, Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, Houston, TX, 2016 - Present

Instructor, The University of Texas Graduate School of Biomedical Sciences, Human Protocol Research, (GS21 1132), Houston, TX, 2016 - 2020

Co-Director of Course, The University of Texas Graduate School of Biomedical Sciences, Ethics in Clinical Trials Research (GS21 1102), Houston, TX, 2012 - 2015

Associate Program Director, Department of The Department of Investigational Cancer Therapeutics, Phase I Fellowship Program, The University of Texas MD Anderson Cancer Center, Houston, TX, 2012 - 2016

Other Professional Positions

Consultant, Mitsubishi Tanabe, Jersey City, New Jersey, 2024 - 2025

Member, NCI/ETCTN Tumor Agnostic Clinical Investigators Touchpoint (TACIT) Committee, Bethesda, MD, 2024 - Present

Member, ETCTN Developmental Therapeutics Committee, Disease Focused Investigators Thoracic and Head and Neck/Thyroid Group, Bethesda, MD, 2023 - Present

Member, NCI/ETCTN Developmental Therapeutics Committee, Disease Focused Investigators Women's Cancers, Bethesda, MD, 2023 - Present

Key Opinion Leader for NUT Carcinoma, Mitsubishi Tanabe, Jersey City, New Jersey, 2022 - Present

Key Opinion Leader for NUT Carcinoma, Epigenetix, Miami, FL, 2022 - Present

Key Opinion Leader for NUT Carcinoma, Zenith Epigenetics Ltd, Calgary, 2022 - 2024

Consultant, CRC Oncology, San Diego, CA, 2022 - 2023

Member, NRG Developmental Therapeutics Committee, Philadelphia, PA, 2021 - Present

Member, NCI ComboMATCH Working Group, Bethesda, MD, 2020 - Present

Consultant, Merck Research Laboratories, North Wales, PA, 2019 - 2019

Key Opinion Leader for NUT Carcinoma, Boehringer-Ingelheim, Ridgefield, CT, 2019 - Present

Key Opinion Leader for NUT Carcinoma, GlaxoSmithKline, Durham, NC, 2018 - 2022

Associate Professor, The University of Texas MD Anderson Cancer Center, Houston, TX, 2016 - Present

Advisory Board Member, Genentech, San Francisco, CA, 2016

Key Opinion Leader for NUT Carcinoma, Abbvie, Chicago, IL, 2015 - 2022

Program Chair, UT MD Anderson Cancer Center, Department of Investigational Cancer Therapeutics Clinical Studies/Journal Club Meeting, Houston, TX, 2015 - Present

Member, Clinical Studies Meeting (Journal Club), Houston, TX, 2013 - 2015

Assistant Professor, The University of Texas Graduate School of Biomedical Sciences Steering Committee, Houston, TX, 2013 - 2016

Faculty Member, The University of Texas Graduate School of Biomedical Sciences MS/PhD Program, Houston, TX, 2012 - Present

Member, Southwest Oncology Group (SWOG) Early Therapeutics and Rare Cancers Committee, Houston, TX, 2011 - Present

Departmental Medical Oncology Fellowship Program Liaison, The University of Texas MD Anderson Cancer Center, Houston, TX, 2010 - 2017

Departmental Visiting Professor/Observer Liaison, The University of Texas MD Anderson Cancer Center, Houston, TX, 2009 - Present

Extramural Institutional Committee Activities

Member, Conflict of Interest Committee (COIC), The University of Texas MD Anderson Cancer Center, 2024 - Present

Texas Medical Board Liaison, Graduate Medical Education Committee, The University of Texas MD Anderson Cancer Center, 2021 - Present

Associate Member, Internal Board Review (IRB 3) Committee, The University of Texas MD Anderson Cancer Center, 2020 - 2024

Vice Chair, Internal Board Review (IRB) 2 Committee, The University of Texas MD Anderson Cancer Center, 2020 - 2024

Mentor, The Functional Mentoring Program, The University of Texas MD Anderson Cancer Center, 2020 - Present

Committee Member, Internal Board Review (IRB) 2 Committee, The University of Texas MD Anderson Cancer Center, 2018 - 2020

Faculty Senator, Faculty Senate Committee, The University of Texas MD Anderson Cancer Center, 2018 - 2020

Participant, Health Educators Fellowship Program (certification program), The University of Texas MD Anderson Cancer Center, 2018 - 2019

Committee Member, Clinical Research Committee, #2, The University of Texas MD Anderson Cancer Center, 2016 - 2018

Member, Graduate Medical Education Committee (GMEC), The University of Texas MD Anderson Cancer Center, 2016 - Present

Member, Faculty Academic Review Committee (FARC), The University of Texas MD Anderson Cancer Center, 2015 - Present

Member, Clinical Education Team, The University of Texas MD Anderson Cancer Center, 2014 - Present

Member, Regional Care Centers (RCC) Liaisons, The University of Texas MD Anderson Cancer Center, 2014 - 2023

Member, Clinical Effectiveness Subcommittee, The University of Texas MD Anderson Cancer Center, 2014 - 2017

Member, Medical Practice Committee, The University of Texas MD Anderson Cancer Center, 2014 - 2020

Member, The University of Texas Graduate School of Biomedical Sciences, Committee for MS/PhD In Patient-Based Research/Clinical Science, The University of Texas MD Anderson Cancer Center, 2013 - Present

Member, Pharmacy and Therapeutics Committee, The University of Texas MD Anderson Cancer Center, 2012 - 2020

Member, The University of Texas MD Anderson Cancer Center Medical Oncology Fellowship Steering Committee, The University of Texas MD Anderson Cancer Center, 2012 - 2023

Honors & Awards

2017	Top Doctor Award 2017, The Leading Physicians of the World
2008 - 2009	Teaching Chief Fellow, The University of Texas MD Anderson Cancer Center
2005 - 2006	Chief Medical Resident, Baylor College of Medicine
2002	Esprit de Corps Award, Louisiana State University School of Medicine
2002	Internal Medicine Award of Excellence, Louisiana State University School of Medicine
2001	Alpha Omega Alpha, Louisiana State University
1997	Magna Cum Laude, Louisiana State University

Professional Memberships

American Association for Cancer Research

2011 - Present

American Society of Hematology

2006 - 2009

American Society of Clinical Oncology

2006 - Present

Alpha Omega Alpha Honor Medical Society

2001 - Present

Selected Presentations & Talks

Local Presentations

2020. Clinical and Immunologic Activity of ALKS 4230 on Tumor Microenvironment in Solid Tumor Patients - ARTISTRY-3. Conference. MD Anderson Cancer Center. Houston, TX, US.
2019. Protocol 2018-0667 A Phase 1b, Open-Label, Dose Escalation Study of PRS-343 in Combination with Atezolizumab in Patients with Specific Her2-Positive Advanced or Metastatic Solid Tumors. Conference. MD Anderson Cancer Center. Houston, TX, US.
2019. 2018-0707 A Phase I, First-In-Human, Multicenter, Open-Label Study of TT-00420, Administered Orally in Adult Patients with Advanced Solid Tumors and Triple Negative Breast Cancers, & 2018-0765 A Phase 1 Study Exploring the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB086550 in Participants with Advanced Solid Tumors. Conference. MD Anderson Cancer Center. Houston, TX, US.
2019. Investigational Cancer Therapeutics, Phase I Fellowship Program: Report of a General and Targeted Needs Assessment. Conference. UT Health Science Center - McGovern Medical School. Houston, TX, US.
2019. Giving Feedback. Conference. MD Anderson Cancer Center. Houston, TX, US.
2018. 2017-0851: First-in-human, open-label, dose-escalation trial with expansion cohorts to evaluate safety of Axl-specific antibody-drug conjugate (HuMax-AXL-ADC) in patients with solid tumors. Conference. MD Anderson Cancer Center. Houston, TX, US.
2018. Phase I/Ib Trial of MK-4280 as Monotherapy and in Combination with Pembrolizumab in Subjects with Advanced Solid Tumors; Modular Phase II Study to Link Combination Immune Therapy to Patients with Advanced Solid and Hematologic Malignancies; & A Phase 1/2, Open-Label, Multicenter Study to Investigate the Safety, Pharmacokinetics, and Efficacy of TAS0728, an Oral Covalent Binding Inhibitor of HER2, in subjects with Advanced Solid Tumors with HER2 or HER3 Abnormalities. Conference. MD Anderson Cancer Center. Houston, TX, US.
2018. An Open-Label, Non-Randomized, Multicenter Study to Determine the Pharmacokinetics and Safety of Niraparib Following a Single Oral dose in patients with Advanced Solid Tumors and Either Normal Hepatic function or Moderate Hepatic Impairment, & An Open-Label, Randomized-Sequence, Multicenter, Single-Crossover Study to Assess the Relative Bioavailability of Niraparib Tablet Formulation Compared to Niraparib Capsule Formulation in Patients with Advanced Solid Tumors. Conference. MD Anderson Cancer Center. Houston, TX, US.
2018. 2016-0430: Phase I Study of the Pan-ERBB Inhibitor Neratinib Given in Combination with Everolimus, Palbociclib or Trametinib in Advanced Cancer Subjects with EGFR Mutation/Amplification, HER2 Mutation/Amplification or HER3/4 Mutation & 2017-0297: A Phase 1, Open-Label, Dose Escalation Study of PRS-343 in Patients with HER2-Positive Advanced or Metastatic Solid Tumors. Conference. MD Anderson Cancer Center. Houston, TX, US.
2017. 2016-0797 Talazoparib Renal Function, 2016-0798 Talazoparib Hepatic Function, 2016-0886 Talazoparib Extended Treatment. Conference. MD Anderson Cancer Center. Houston, TX, US.
2017. Protocols 2016-0214 D6060C00002 Medimmune & NCI9771 Veliparib + VX-970 + Cisplatin. Conference. MD Anderson Cancer Center. Houston, TX, US.
2017. A Phase 1 Multicenter, Open-label, Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Antitumor Activity of MEDI0562 in Combination with Immune Therapeutic Agents in Adult Subjects with Advanced Solid Tumors. Conference. MD Anderson Cancer Center. Houston, TX, US.
2017. Phase I Study of Veliparib, an Oral PARP Inhibitor, and VX-970, an ART Inhibitor, in Combination with Cisplatin in Patients with Refractory Solid Tumors. Conference. MD Anderson Cancer Center. Houston, TX, US.
2016. CGWN323X2101 Protocol Training Am1. Conference. MD Anderson Cancer Center. Houston, TX, US.
2016. Protocol 2015-1116: CRLX301-101. Conference. MD Anderson Cancer Center. Houston, TX, US.
2015. Protocol 2015-0838, Evaluation of an Alternative Schedule for CRLX101 Alone and in Combination with Bevacizumab in Subjects with Advanced Solid Tumor Malignancies; and 2015-0871, A Clinical Trial of Pembrolizumab (MK-3475) Evaluating Predictive Biomarkers in Subjects with Advanced Solid Tumors (KEYNOTE 158). Conference. MD Anderson Cancer Center. Houston, TX, US.
2014. Protocol 2013-1009: LDE-225. Conference. MD Anderson Cancer Center. Houston, TX, US.
2014. Protocol 2013-1008: Phase Ib Study of MK-3475 in Subjects with Select Advanced Solid Tumors. Conference. MD Anderson Cancer Center. Houston, TX, US.
2014. Protocol 2013-1009: Phase II Study of LDE225 for PTCH1 and SMO-mutated Tumors. Conference. MD Anderson Cancer Center. Houston, TX, US.
2014. Protocol 2013-0904: Phase 2 Study of Neratinib in Patients with Solid Tumors with EGFR, HER2, HER3 Mutations or EGFR Gene Amplification. Conference. MD Anderson Cancer Center. Houston, TX, US.
2013. Protocol 2013-0864 MEK 162, and Protocol 2013-0865 Dovitinib. Conference. MD Anderson Cancer Center. Houston, TX, US.
2013. Protocol 2013-0682: Linking Targeted Therapy with BKM120 for Patients with PI3K-Activated Tumors. Conference. MD Anderson Cancer Center. Houston, TX, US.
2013. Protocol 2013-0633 Phase I/II Study Using GSK525762 in Subjects with NUT Midline Carcinoma (NMC) and Other Cancers. Conference. MD Anderson Cancer Center. Houston, TX, US.
2011. Salivary Duct Carcinoma: targeting the PI3 kinase pathway by blocking mTOR with temsirolimus. Conference. Department of Pathology. Houston, TX, US.
2010. An Innovative Phase I Trial Design Allowing for the Identification of Multiple Potential Maximum Tolerated Doses with Combination Therapy of Targeted Agents. Conference. Department of Biostatistics. Houston, TX, US.
2009. The Curious Case of a Rash. Conference. Baylor College of Medicine and University of Texas M. D. Anderson Cancer Center. Houston, TX, US.

National Presentations

2025. Biomarker analyses of WEE1 inhibition in patients with refractory CCNE1 amplified solid tumors. Poster. AAR-NCI-EORTC 2025. Boston, MA, US.
2025. Research biopsy participation and safety in cancer therapeutic trials. Poster. AAR-NCI-EORTC 2025. Boston, MA, US.
2025. Discrepancies Between Calculated and Actual Creatinine Clearance: A Phase 1 Trial Unit Experience. Poster. AAR-NCI-EORTC 2025. Boston, MA, US.
2025. Clinical Utility of Comprehensive Genomic and Transcriptomic Analysis to Guide Therapy for Patients with Metastatic Solid Tumors. Poster. AAR-NCI-EORTC 2025. Boston, MA, US.
2025. Clinical Outcomes and Biomarker Correlates of Patients with Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma Treated with Novel Immunotherapies in Phase 1 Trials. Poster. AAR-NCI-EORTC 2025. Boston, MA, US.
2025. SPYK04, a novel RAF-MEK molecular glue: Dose escalation (DE) in first-in-human study for MAPK pathway-altered solid tumors. Poster. 2025 ASCO Annual Meeting. Chicago, IL, US.
2025. Phase 1 study of zavondemstat (TACH101), a first-in-class KDM4 inhibitor, in patients with advanced solid tumors: Results on safety, pharmacokinetics, and anti-tumor activity. Poster. 2025 ASCO Annual Meeting. Chicago, IL, US.
2025. EphA2 siRNA in DOPC nanoliposomes (EPHARNA): A phase I clinical trial in patients with solid tumors. Poster. 2025 ASCO Annual Meeting. Chicago, IL, US.
2025. Clinical outcomes of patients with or without DNA repair pathway alterations by treatment type: The MD Anderson Cancer Center IMPACT 2 study. Poster. 2025 ASCO Annual Meeting. Chicago, IL, US.
2025. Sigvotatug vedotin (SV), an investigational integrin beta-6 (IB6)–directed antibody‒drug conjugate (ADC), and pembrolizumab combination therapy: Initial results from an ongoing phase 1 study (SGNB6A-001). Invited. 2025 ASCO Annual Meeting. Chicago, IL, US.
2025. Phase I dose escalation trial of STX-001, an LNP-encapsulated self-replicating mRNA expressing IL-12, in patients (pts) with advanced solid tumors. Poster. 2025 ASCO Annual Meeting. Chicago, IL, US.
2025. Outcomes of young-onset colorectal cancer vs late-onset colorectal cancer patients on phase 1 matched and non-matched therapies. Poster. 2025 ASCO Annual Meeting. Chicago, IL, US.
2025. Colorectal cancer with gene fusions: Navigating the genomic landscape and treatment selection in a phase I unit. Poster. 2025 ASCO Annual Meeting. Chicago, IL, US.
2025. Therapeutic responses in 555 advanced NSCLC patients enrolled in phase I studies at MD Anderson Cancer Center. Conference. 2025 ASCO Annual Meeting. Chicago, IL, US.
2025. Phase 1 clinical update of IMA203, an autologous TCR-T targeting PRAME in patients with PD1 refractory metastatic melanoma. Invited. 2025 ASCO Annual Meeting. Chicago, IL, US.
2025. Clinical utility of comprehensive transcriptome testing in advanced solid tumors. Poster. 2025 ASCO Annual Meeting. Chicago, IL, US.
2025. Phase 1 dose escalation and expansion study of the PTK7-targeted antibody-drug conjugate DAY301 in patients with locally advanced or metastatic solid tumors. Poster. AACR Annual Meeting 2025. Chicago, IL, US.
2025. Safety and pharmacokinetics of tinengotinib monotherapy in different doses and dosing schedules in advanced solid tumors. Poster. AACR Annual Meeting 2025. Chicago, IL, US.
2025. Clinical and translational study of the TGF-β monoclonal antibody SAR439459 in combination with the PD-1 inhibitor cemiplimab for patients (pts) with advanced solid tumors: Results from the phase 1b TACTIC trial. Poster. AACR Annual Meeting 2025. Chicago, IL, US.
2025. Genomic landscape in metaplastic breast cancer: Results from the AACR GENIE Database. Invited. AACR Annual Meeting 2025. Chicago, IL, US.
2025. INCLINE-101: A Phase 1/2 Trial of TAC-001 (TLR9 agonist-CD22 mAb) in Advanced or Metastatic Solid Tumors. Poster. AACR Annual Meeting 2025. Chicago, IL, US.
2025. Modulating treatment outcomes of patients with solid tumors in immunotherapy trials: a drug interaction analysis from a phase I unit. Poster. AACR Annual Meeting 2025. Chicago, IL, US.
2025. Food choices of patients with advanced cancer at start of early-phase combination trials with immune checkpoint blockade. Poster. AACR Annual Meeting 2025. Chicago, IL, US.
2025. Correlation of clinical and biomarker data in FGFR inhibitor failed metastatic cholangiocarcinoma patients with tumor response to tinengotinib. Poster. AACR Annual Meeting 2025. Chicago, IL, US.
2025. TalaCom: Phase Ib investigator-initiated trial combining talazoparib and axitinib in patients with DNA damage response mutated cancers or BRCA1/2 wildtype ovarian cancer incorporating prospective intrapatient dose titration. Invited. ESMO Targeted Anticancer Therapies (TAT) Congress 2025. Paris, FR.
2025. Impact of liver metastases and systemic biomarkers on immunotherapy response and survival outcomes in patients with solid tumors. Poster. AACR IO 2025. Los Angeles, CA, US.
2024. Phase I dose-escalation trial of AMXT 1501 dicaprate plus difluoromethylornithine: A dual agent approach targeting immunosuppressive polyamine metabolism. Poster. SITC 2024. Houston, TX, US.
2024. Impact of liver metastasis on immunotherapy in patients with solid tumors. Poster. SITC 2024. Houston, TX, US.
2024. Tumor Microenvironment Pharmacodynamic Effect of Nemvaleukin Less Frequent Intravenous Dosing in multiple solid tumors: Results from the phase 1/2 ARTISTRY-3 study. Poster. SITC 2024. Houston, TX, US.
2024. Artificial Intelligence-powered assessment of tumor microenvironment in pre-treatment and on-treatment biopsies informs treatment outcomes to pembrolizumab in patients with rare tumors. Invited. SITC 2024. Houston, TX, US.
2024. Patient-reported symptom interference with activity- and mood-related functioning prior to start of an early-phase oncology combination trial including immune checkpoint blockade. Conference. 2024 ASCO Annual Meeting. Chicago, IL, US.
2024. Molecular characterization of NUT carcinoma: A report from the NUT carcinoma registry. Poster. 2024 ASCO Annual Meeting. Chicago, IL, US.
2024. A phase 1/1b first-in-human (FIH) study of JZP898 as monotherapy and in combination with pembrolizumab in adult patients with advanced or metastatic solid tumors. Poster. 2024 ASCO Annual Meeting. Chicago, IL, US.
2024. A phase-1 dose escalation and expansion study of EP0031, a next-generation selective RET inhibitor (SRI), in patients with SRI-naïve or pretreated advanced RET-altered NSCLC and other tumors. Poster. 2024 ASCO Annual Meeting. Chicago, IL, US.
2024. A phase I trial of intratumoral STX-001: A novel self-replicating mRNA expressing IL-12 alone or with pembrolizumab in advanced solid tumors. Poster. 2024 ASCO Annual Meeting. Chicago, IL, US.
2024. Efficacy and safety of sigvotatug vedotin, an investigational ADC, in NSCLC: Updated phase 1 results (SGNB6A-001). Poster. 2024 ASCO Annual Meeting. Chicago, IL, US.
2024. A phase 1 study evaluating the safety, pharmacokinetics, and efficacy of fadraciclib, an oral CDK2/9 inhibitor, in patients with advanced solid tumors and lymphoma. Poster. 2024 ASCO Annual Meeting. Chicago, IL, US.
2024. Interim analysis of ABM-1310, a blood-brain barrier-penetrant BRAF inhibitor, in patients with BRAF V600-mutated solid tumors. Poster. 2024 ASCO Annual Meeting. Chicago, IL, US.
2024. Recommended phase 2 dose (RP2D) of nemvaleukin alfa in patients (pts) with advanced solid tumors treated with less frequent intravenous (IV) dosing (ARTISTRY-3). Poster. 2024 ASCO Annual Meeting. Chicago, IL, US.
2024. A phase 1 dose-escalation and expansion study of an intratumorally administered dual STING agonist (ONM-501) alone and in combination with cemiplimab in patients with advanced solid tumors and lymphomas. Poster. 2024 ASCO Annual Meeting. Chicago, IL, US.
2024. A first-in-human phase I study of ATG-031, anti-CD24 antibody, in patients with advanced solid tumors or B-cell non-Hodgkin lymphomas (PERFORM). Poster. 2024 ASCO Annual Meeting. Chicago, IL, US.
2024. A phase 1 study of the BET inhibitor ZEN003694 in combination with the MEK1/2 inhibitor binimetinib in solid tumors with RAS pathway alterations and triple-negative breast cancer (NCI number 10449). Conference. 2024 ASCO Annual Meeting. Chicago, IL, US.
2024. A phase I study of TAK-659 and paclitaxel in patients with taxane-refractory advanced solid tumors. Conference. 2024 ASCO Annual Meeting. Chicago, IL, US.
2024. Response to RAF/MEK/ERK inhibitors in patients with RAS altered and wild-type tumors. Conference. 2024 ASCO Annual Meeting. Chicago, IL, US.
2024. Results of IMPACT 2, a randomized study evaluating molecular profiling and targeted agents in metastatic cancer at MD Anderson Cancer Center. Poster. 2024 ASCO Annual Meeting. Chicago, IL, US.
2024. Telehealth consultations and recruitment trends in clinical trials: A retrospective analysis at investigational cancer therapeutics, a dedicated phase I department at The University of Texas MD Anderson Cancer Center. Poster. 2024 ASCO Annual Meeting. Chicago, IL, US.
2024. NCI10217: Phase Ib biomarker-driven tumor-agnostic combination (Combo) trial of copanlisib (Copa) and olaparib (Ola) in molecularly-selected patients (pts) with advanced cancers with PIK3CA hotspot, PTEN and DNA damage response (DDR) mutations. Invited. AACR Annual Meeting 2024. San Diego, CA, US.
2024. Tinengotinib in patients with advanced solid tumors harboring actionable FGFR1-3 mutations. Poster. AACR Annual Meeting 2024. San Diego, CA, US.
2024. Synergistic cytotoxicity of histone deacetylase and poly-ADP ribose polymerase inhibitors and decitabine in pancreatic cancer cells: implications for novel therapy. Poster. AACR Annual Meeting 2024. Sn Diego, CA, US.
2024. Comprehensive genomic and transcriptomic analysis to guide therapy for patients with metastatic solid tumors. Conference. AACR Annual Meeting 2024. San Diego, CA, US.
2024. The efficacy and safety of tinengotinib in patients with heavily pretreated metastatic castration-resistant prostate cancer (mCRPC). Poster. 2024 ASCO Genitourinary Cancers Symposium. San Francisco, CA, US.
2024. Clinical characterization and therapeutic outcomes of patients (pts) with colorectal cancer (CRC) harboring somatic BRCA1/2 mutations. Poster. ASCO Gastrointestinal Cancers Symposium. San Francisco, CA, US.
2023. The efficacy and safety of tinengotinib in patients with advanced or metastatic HR+/HER2-breast cancer or TNBC. Invited. San Antonio Breast Cancer Symposium (SABCS) 2023. San Antonio, TX, US.
2023. A phase 1, first-in-human (FIH), open-label, dose-finding and expansion study of XmAb808, a B7H3 x CD28 bispecific antibody, in combination with pembrolizumab in patients with advanced solid tumors. Conference. SITC Annual Meeting 2023. San Diego, CA, US.
2023. Assessment of safety and immunologic activity of nemvaleukin alfa in patients with advanced solid tumors treated with less frequent intravenous dosing (ARTISTRY-3). Conference. SITC Annual Meeting 2023. San Diego, CA, US.
2023. Subcutaneous nemvaleukin alfa in combination with pembrolizumab in patients with refractory solid tumors (ARTISTRY-2). Conference. SITC Annual Meeting 2023. San Diego, CA, US.
2023. Patient-reported baseline symptomatic adverse events in early-phase trials of combination treatments with immune checkpoint blockade, and their association with concurrent global health status, health utilities and clinical factors. Conference. AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics. Boston, MA, US.
2023. Preliminary results from a phase I/II study evaluating the safety, tolerability, and efficacy of EP0031, a next generation selective RET inhibitor, in patients with advanced RET-altered malignancies. Conference. AACR-NCI-EORTC International Conference on Moledular Targets and Cancer Therapeutics. Boston, MA, US.
2023. Temsirolimus in combination with metformin in patients with advanced or recurrent endometrial cancer. Conference. AACR-NCI-EORTC International Conference on Moledular Targets and Cancer Therapeutics. Boston, MA, US.
2023. Baseline symptom, health status, and health utilities in patients in early-phase clinical trials combining immune checkpoint blockade with other anticancer therapies. Invited. 2023 ASCO Annual Meeting. Chicago, IL, US.
2023. Molecular landscape and survival outcomes on early phase clinical trials in sporadic young onset colorectal cancer. Conference. 2023 ASCO Annual Meeting. Chicago, IL, US.
2023. Initial chemotherapy for locally advanced and metastatic NUT carcinoma: A report from the NUT Carcinoma Registry. Conference. 2023 ASCO Annual Meeting. Chicago, IL, US.
2023. A phase 1, multicenter, open-label study of a new BRAF inhibitor ABM-1310 in adult patients (pts) with BRAFv600-mutated solid tumors. Conference. 2023 ASCO Annual Meeting. Chicago, IL, US.
2023. RAF-inhibitor rechallenge therapy in BRAF aberrated pan-cancers: RE-RAFFLE study. Conference. ASCO Annual Meeting. Chicago, IL, US.
2023. First-in-human phase 1 study of pimicotinib (ABSK021), a CSF-1R inhibitor, in patients with advanced solid tumors. Conference. 2023 ASCO Annual Meeting. Chicago, IL, US.
2023. Lefitolimod (TLR agonist) and ipilimumab in patients with advanced solid tumors: A phase I trial. Conference. 2023 ASCO Annual Meeting. Chicago, IL, US.
2023. Preliminary safety and efficacy of tinengotinib tablets as monotherapy and combination therapy in advanced solid tumors: A phase Ib/II clinical trial. Invited. 2023 ASCO Annual Meeting. Chicago, IL, US.
2023. SGN-B6A, an integrin beta-6 (ITGB6)-targeted antibody-drug conjugate (ADC), in patients with advanced solid tumors: Updated results from a phase 1 study (SGNB6A-001). Conference. 2023 ASCO Annual Meeting. Chicago, IL, US.
2023. A phase 1, multicenter, open-label study of a new BRAF inhibitor ABM-1310 in adult patients (pts) with BRAFv600-mutated solid tumors. Conference. 2023 ASCO Annual meeting. Chicago, IL, US.
2023. A phase 1/2, first-in-human trial of ZB131, a novel antibody targeting cancer-specific plectin (CSP) in advanced solid tumors. Conference. 2023 ASCO Annual Meeting. Chicago, IL, US.
2023. Dynamic changes in monocyte and reticulocyte counts predict mechanism-based anemia development and recovery during ATR inhibitor treatment in phase I/II trials. Conference. AACR Annual Meeting 2023. Orlando, FL, US.
2023. ENB-003, an ETBR antagonist, in combination with pembrolizumab for advanced solid tumor: The ENBolden trial. Conference. AACR Annual Meeting 2023. Orlando, FL, US.
2023. GQ1001: A next generation HER2-targeting ADC that exhibits promising early clinical efficacy with excellent tolerance in a multi-center, Phase Ia study. Conference. AACR Annual Meeting 2023. Orlando, FL, US.
2023. Phase Ib Study of Pembrolizumab in Combination with Intratumoral Injection of Clostridium novyi-NT in Patients with Advanced Solid Tumors. Conference. AACR Annual Meeting 2023. Orlando, FL, US.
2023. HER2-low expression in patients with advanced or metastatic solid tumors. Conference. AACR Annual Meeting 2023. Orlando, FL, US.
2022. A phase 1 study exploring the safety and tolerability of the small-molecule PD-L1 inhibitor, INCB099280, in patients with select advanced solid tumors. Conference. SITC 2022. Boston, MA, US.
2022. A phase 1 study exploring the safety and tolerability of the small molecule PD-L1 inhibitor, INCB086550, in patients with select advanced tumors. Conference. SITC 2022. Boston, MA, US.
2022. A phase 1, first-in-human, open-label, multicenter study of INCA32459, a bispecific anti-PD1 and anti-LAG-3 antibody, in patients with select advanced malignancies. Conference. SITC 2022. Boston, MA, US.
2022. A first-in-human trial of an integrin beta-6 targeted antibody-drug conjugate (ADC), SGN-B6A, in patients with advanced solid tumors: Interim results of a Phase 1 study (SGNB6A-001). Conference. SITC 2022. Boston, MA, US.
2022. NCI10329: Phase Ib Sequential Trial of Agents against DNA Repair (STAR) Study to investigate the sequential combination of the Poly(ADP-Ribose) Polymerase inhibitor (PARPi) olaparib (ola) and WEE1 inhibitor (WEE1i) adavosertib (ada) in patients (pts) with DNA Damage Response (DDR)-aberrant advanced tumors, enriched for BRCA1/2 mutated and CCNE1 amplified cancers. Invited. 34th EORTC-NCI-AACR Symposium. Barcelona, ES.
2022. A phase 1/2, open-label, multicenter study to investigate the safety, pharmacokinetics, and efficacy of fadraciclib (CYC065), an oral CDK2/9 inhibitor, in subjects with advanced solid tumors and lymphoma. Conference. 34th EORTC-NCI-AACR Symposium. Barcelona, ES.
2022. Neratinib efficacy in patients with EGFR exon 18-mutant non-small-cell lung cancer: findings from the SUMMIT basket trial. Conference. 34th EORTC-NCI-AACR Symposium. Barcelona, ES.
2022. First-in-human, phase I study of TT-00420, a multiple kinase inhibitor, as a single agent in advanced solid tumors. Conference. 2022 ASCO Annual Meeting. Chicago, IL, US.
2022. Repeat large panel genomic sequencing identifies actionable alterations and characterizes the genomic landscape in patients with metastatic solid tumors. Conference. 2022 ASCO Annual Meeting. Chicago, IL, US.
2022. Phase Ib study of selinexor and eribulin combination in advanced solid tumors and triple-negative breast cancer. Conference. 2022 ASCO Annual Meeting. Chicago, IL, US.
2022. Baseline predictors of hematological toxicity in patients with advanced cancer treated with ATR inhibitors in phase I/II clinical trials. Conference. ASCO Annual Meeting. Chicago, IL, US.
2022. ARTISTRY-3: Effect of nemvaleukin alfa with a less frequent IV dosing schedule as monotherapy and in combination with pembrolizumab and impact on the tumor microenvironment (TME) in patients (pts) with advanced solid tumors. Conference. 2022 ASCO Annual Meeting. Chicago, IL, US.
2022. Targeting HER2 mutation–positive advanced biliary tract cancers with neratinib: Final results from the phase 2 SUMMIT basket trial. Conference. 2022 ASCO Annual Meeting. Chicago, IL, US.
2022. Effect of immunotherapy and time-of-day infusion chronomodulation on survival in advanced cancers. Conference. 2022 ASCO Annual Meeting. Chicago, IL, US.
2022. Phase Ib trial of selinexor (SEL) in combination with nivolumab (NIVO) alone or nivolumab plus ipilimumab (NIVO+IPI) in patients (pts) with advanced malignancies: The renal cell carcinoma (RCC) experience. Conference. 2022 ASCO Annual Meeting. Chicago, IL, US.
2022. A phase 2, multi-center, open-label study of cinrebafusp alfa (PRS-343) in combination with ramucirumab and paclitaxel in patients with HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma and in combination with tucatinib in patients with HER2 low gastric or gastroesophageal junction (GEJ) adenocarcinoma. Conference. AACR Annual Meeting 2022. New Orleans, LA, US.
2022. Discordance of HER2 expression and/or amplification on repeat testing. Conference. AACR Annual Meeting 2022. New Orleans, LA, US.
2022. B-Raf V600E harboring non-melanoma cancers treated with Vemurafenib monotherapy and in combination with Everolimus/Sorafenib/Crizotinib/Paclitaxel+ Carboplatin: A pooled analysis of five phase 1/2 studies. Conference. AACR Annual Meeting 2022. New Orleans, LA, US.
2022. Preliminary results of a phase 1 study of sea-CD40, gemcitabine, nab-paclitaxel, and pembrolizumab in patients with metastatic pancreatic ductal adenocarcinoma (PDAC). Conference. ASCO Gastrointestinal Cancers Symposium. San Francisco and Virtual, CA, US.
2021. Phase 1 Study of INCB086550, an ORAL PD-L1 Inhibitor, In Immune-Checkpoint Naive Patients with Advanced Solid Tumors. Conference. SITC 36th Annual Meeting 2021. Washington, DC, US.
2021. A Phase 1/2 Study Of SBT6050 Combined With Trastuzumab Deruxtecan (T-Dxd) Or Trastuzumab And Tucatinib With Or Without Capecitabine In Patients With Her2-Expressing Or Her2-Amplified Cancers. Conference. SITC 36th Annual Meeting 2021. Washington, DC, US.
2021. SYNB1891, A Bacterium Engineered To Produce A Sting Agonist, Demonstrates Target Engagement In Humans Following Intratumoral Injection. Conference. SITC 36th Annual Meeting 2021. Washington, DC, US.
2021. Compliance with Dietary Guidelines and Its Relationship with Symptoms and Clinical Outcomes in Patients with Advanced Cancer in Early-Phase Oncology Clinical Trials. Conference. 2021 ASCO Quality Care Symposium. Boston, MA, US.
2021. A first-in-human phase I study of FS120, an OX40/CD137 tetravalent bispecific antibody, in patients with advanced malignancies. Conference. ESMO Congress 2021. Virtual Confernence, US.
2021. Adherence to the Food and Drug Administration (FDA) Guidance for the Co-Development of Two or More Investigational New Drugs in Phase 1/2 Cancer Trials. Invited. ESMO Congress 2021. Virtual Conference, US.
2021. Interim results of a phase I/Ib study of SBT6050 monotherapy and pembrolizumab combination in patients with advanced HER2-expressing or amplified solid tumors. Conference. ESMO Congress 2021. Virtual Conference, US.
2021. A first-in-human trial of the integrin beta-6-targeted antibody–drug conjugate, SGN-B6A, in patients with advanced solid tumors. Conference. ESMO Congress 2021. Virtual Conference, US.
2021. ACE1702, a first-in-class, off-the-shelf, selected natural killer cell [oNK] product using antibody cell conjugation technology [ACC], with pre-clinical and early clinical activity in HER2 < 3+ tumors. Conference. ESMO Congress 2021. Virtual Conference, US.
2021. Ph I/II study of PI3K-β inhibitor GSK2636771 (G771) in combination with pembrolizumab (P) in patients (pts) with PTEN loss and melanoma or other advanced solid tumors. Conference. ESMO Congress 2021. Virtual Conference, US.
2021. Results of a phase 1 dose-escalation study of AMV564, a novel T-cell engager, alone and in combination with pembrolizumab in patients with relapsed/refractory solid tumors. Conference. 2021 ASCO Annual Meeting. Virtual Meeting, US.
2021. Initiative for Molecular Profiling and Advanced Cancer Therapy (IMPACT2): Challenges and Opportunities in Conducting an MD Anderson Randomized Study in Precision Oncology. Conference. 2021 ASCO Annual Meeting. Virtual Meeting, US.
2021. A phase 1 study of SGN-B6A, an antibody-drug conjugate targeting integrin beta-6, in patients with advanced solid tumors (SGNB6A-001, Trial in Progress). Conference. 2021 ASCO Annual Meeting. Virtual Meeting, US.
2021. Selection of the recommended phase 2 dose (RP2D) for subcutaneous nemvaleukin alfa: ARTISTRY-2. Conference. 2021 ASCO Annual Meeting. Virtual Meeting, US.
2021. Phase I study of mTORC1/2 inhibitor sapanisertib (TAK-228) in combination with metformin in patients (pts) with mTOR/AKT/PI3K pathway alterations and advanced solid malignancies. Invited. 2021 ASCO Annual Meeting. Virtual Meeting, US.
2021. Phase I study of TT-00420, a multiple kinase inhibitor, as a single agent in advanced solid tumors. Conference. 2021 ASCO Annual Meeting. Virtual Meeting, US.
2021. First-in-human biomarker-driven phase I trial of the potent and selective glutaminase-1 (GLS1) inhibitor IACS-6274 (IPN60090) in patients (pts) with molecularly selected advanced solid tumors. Invited. 2021 ASCO Annual Meeting. Virtual Meeting, US.
2021. Patients with advanced solid cancers treated with ERK inhibitors exhibit pseudo-progression in lymphatic nodes. Conference. 2021 ASCO Annual Meeting. Virtual Meeting, US.
2021. Selinexor in combination with weekly paclitaxel in patients with advanced or metastatic solid tumors: Results of an open label, single-center, multiarm phase 1b study. Conference. 2021 ASCO Annual Meeting. Virtual Meeting, US.
2021. Whole exome sequencing of tumor tissue and circulating tumor DNA in gastrointestinal stromal tumors (GIST). Conference. AACR Annual Meeting 2021. Virtual Meeting, US.
2021. Phase II trial of the Wee1 inhibitor adavosertib in advanced refractory solid tumors with CCNE1 amplification. Conference. AACR Annual Meeting 2021. Virtual Meeting, US.
2021. Clinical and biomarker activity of PRS-343, a bispecific fusion protein targeting 4-1BB and Her2, from a phase 1 study in patients with advanced solid tumors (Study PRS-343-PCS_04_16). Invited. AACR Annual Meeting 2021. Virtual Meeting, US.
2021. Phase I trial of the triplet berzosertib (M6620, VX-970), veliparib and cisplatin (BVP) in patients with advanced solid tumors. Conference. AACR Annual Meeting 2021. Virtual Meeting, US.
2021. Bromodomain and Extra-terminal (BET) Inhibitors: A Brief Overview and Summary of the Clinical Experience to Date. Invited. The International Conference on Nut Carcinoma. Boston, MA, US.
2021. Overview of international experience. When is best time during therapy to treat with BETi? What is in the future for BETi?. Invited. First International Conference on NUT Carcinoma. Virtual Meeting, US.
2021. Targeting HER2 (ERBB2) mutation-positive advanced biliary tract cancers with neratinib: results from the phase II SUMMIT 'basket' trial. Conference. Gastrointestinal Cancers Symposium. Virtual Meeting, US.
2020. Immune correlates associated with clinical outcomes in patients with advanced malignancies treated with avelumab and OX40 agonist. Conference. SITC Annual Meeting 2020. Virtual Meeting, US.
2020. A phase 1/1b study of SBT6050, a HER2-directed monoclonal antibody conjugated to a toll-like receptor 8 agonist, in subjects with advanced HER2-317expressing solid tumors. Conference. SITC Annual Meeting 2020. Virtual Meeting, US.
2020. Interleukin-8–neutralizing monoclonal antibody BMS-986253 plus nivolumab (NIVO) in biomarker-enriched, primarily anti–PD-(L)1–experienced patients with advanced cancer: initial phase 1 results. Conference. SITC Annual Meeting 2020. Virtual Meeting, US.
2020. Single-agent anti-tumor activity in relapsed/refractory solid tumors: interim data from the Phase 1 solid tumor trial of AMV564, a novel T-cell engager. Conference. SITC Annual Meeting 2020. Virtual meeting, US.
2020. Pharmacodynamic biomarkers demonstrate T-cell activation in patients treated with the oral PD-L1 inhibitor INCB086550 in a phase 1 clinical trial. Conference. SITC Annual Meeting 2020. Virtual Meeting, US.
2020. A phase I dose escalation study of PRS-343, a HER2/4-1BB bispecific molecule, in patients with HER2-positive malignancies. Invited. ESMO Virtual Congress 2020. Virtual Meeting, US.
2020. A phase Ib study on a TRPV6-inhibitor, SORC13 in patients with advanced solid tumours. Conference. ESMO Virtual Congress 2020. Virtual Meeting, US.
2020. Validation of prognostic scores in patients with metastatic bladder carcinoma (mBC) enrolled in early phase clinical trials. Conference. ESMO Virtual Congress 2020. Virtual Meeting, US.
2020. Selinexor in combination with carboplatin and paclitaxel in patients with advanced or metastatic solid tumours: Results of an open label, single-center, multi-arm phase Ib study. Conference. ESMO Virtual Conference 2020. Virtual Meeting, US.
2020. Selinexor in combination with topotecan in patients with advanced or metastatic solid tumours: Results of an open label, single-center, multi-arm phase Ib study. Conference. ESMO Virtual Congress 2020. Virtual Meeting, US.
2020. Phase I study of TT-00420, a multiple kinase inhibitor, in patients with triple negative breast cancers and other advanced solid tumors. Conference. AACR Virtual Annual Meeting II. Virtual Meeting, US.
2020. Analysis of taxane drug target engagement of microtubules in circulating tumor cells from metastatic castration resistant prostate cancer patients treated with CRLX301, a nanoparticle of docetaxel. Conference. AACR Virtual Annual Meeting II. Virtual Meeting, US.
2020. Temsirolimus in combination with metformin in patients with advanced or refractory endometrial cancers. Conference. AACR Virtual Annual Meeting II. Virtual Meeting, US.
2020. Evaluation of cytotoxic T cell infiltration and clinical benefit from PD-L1 checkpoint inhibition among PIK3CA mutant microsatellite stable (MSS) metastatic adenocarcinoma patients. Conference. AACR Virtual Annual Meeting II. Virtual Meeting, US.
2020. Pharmacokinetics and safety following a single oral dose of niraparib in patients with moderate hepatic impairment. Conference. ASCO20 Virtual Meeting. Virtual Meeting, US.
2020. Pembrolizumab for previously treated advanced anal squamous cell carcinoma: Pooled results from the KEYNOTE-028 and KEYNOTE-158 studies. Conference. ASCO20 Virtual Meeting. Virtual Meeting, US.
2020. Genomically informed longitudinal monitoring of circulating tumor DNA (ctDNA) predicts outcomes of cancer therapy. Conference. ASCO20 Virtual Meeting. Virtual Meeting, US.
2020. Outcomes and the impact of genomic characteristics on patients with metastatic urothelial carcinoma enrolled in early phase trials. Conference. ASCO20 Virtual Meeting. Virtual Meeting, US.
2020. Patient-reported out-of-pocket costs and financial toxicity during early-phase 0ncology clinical trials. Conference. ASCO20 Virtual Meeting. Virtual Meeting, US.
2020. Phase I clinical trials as a therapeutic option for patients with metastatic renal cell carcinoma (mRCC). Conference. ASCO20 Virtual Meeting. Virtual Meeting, US.
2020. Safety and tolerability of MEDI0562 in combination with durvalumab or tremelimumab in patients with advanced solid tumors. Invited. ASCO20 Virtual Meeting. Virtual Meeting, US.
2020. Anti-CTLA-4 probody BMS-986249 alone or in combination with nivolumab in patients with advanced cancers: Initial phase I results. Conference. ASCO20 Virtual Meeting. Virtual Meeting, US.
2020. BET inhibitor molibresib for the treatment of advanced solid tumors: Final results from an open-label phase I/II study. Conference. ASCO20 Virtual Meeting. Virtual Meeting, US.
2020. Phase I/II dose-escalation and expansion study of FLX475 alone and in combination with pembrolizumab in advanced cancer. Conference. ASCO20 Virtual Meeting. Virtual Meeting, US.
2020. A phase I study to evaluate the T-cell engager AMV564 alone and in combination with pembrolizumab in subjects with advanced solid tumors. Conference. ASCO20 Virtual Meeting. Virtual Meeting, US.
2020. A phase I/II, two-part, multicenter, first-in-human study of DS-7300a in patients with advanced solid malignant tumors. Conference. ASCO20 Virtual Meeting. Virtual Meeting, US.
2020. Radiomics to predict response to pembrolizumab in patients with advanced rare cancers. Conference. 2020 ASCO-SITC Clinical Immuno-Oncology Symposium. Orlando, FL, US.
2019. Everolimus, letrozole and trastuzumab in hormone receptor-positive, HER2-positive/amplified or mutant metastatic cancer: Evaluating synergy and overcoming resistance. Conference. SABCS 2019. San Antonio, TX, US.
2019. A phase I dose escalation study to evaluate the safety and tolerability of evofosfamide in combination with ipilimumab in advanced solid malignancies. Conference. SITC Annual Meeting 2019. National Harbor, MD, US.
2019. A phase 1 dose escalation study of PRS-343, a HER2/4-1BB bispecific molecule, in patients with HER2-positive malignancies. Invited. SITC Annual Meeting 2019. National Harbor, MD, US.
2019. Combinatorial therapies of neratinib for HER2-amplified cancer. Conference. AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics. Boston, MA, US.
2019. Out-of-pocket costs and financial toxicity experienced by patients in early-phase clinical trials. Conference. 2019 ASCO Quality Care Symposium. San Diego, CA, US.
2019. Pembrolizumab (pembro) for advanced biliary adenocarcinoma: Results from the KEYNOTE-028 (KN028) and KEYNOTE-158 (KN158) basket studies. Conference. 2019 ASCO Annual Meeting. Chicago, IL, US.
2019. CT-based radiogenomic signature to identify isocitrate dehydrogenase (IDH)1/2 mutations in advanced intrahepatic cholangiocarcinoma. Conference. 2019 ASCO Annual Meeting. Chicago, IL, US.
2019. Breaking the Code: Drugging Difficult Targets and Tumors. Invited. 2019 ASCO Annual Meeting. Chicago, IL, US.
2019. Phase I trial of IACS-010759 (IACS), a potent, selective inhibitor of complex I of the mitochondrial electron transport chain, in patients (pts) with advanced solid tumors. Conference. ASCO Annual Meeting 2019. Chicago, IL, US.
2019. Phase 1 trial of TLR9 agonist lefitolimod in combination with CTLA-4 checkpoint inhibitor ipilimumab in advanced tumors. Conference. 2019 ASCO Annual Meeting. Chicago, IL, US.
2019. Safety and tolerability of veliparib, an oral PARP inhibitor, and M6620 (VX-970), an ATR inhibitor, in combination with cisplatin in patients with refractory solid tumors. Conference. 2019 ASCO Annual Meeting. Chicago, IL, US.
2019. A phase I, first-in-human, dose-escalation and dose-expansion study of the multitarget kinase inhibitor TT-00420 in patients with advanced solid tumors. Conference. 2019 ASCO Annual Meeting. Chicago, IL, US.
2019. Phase II study of spartalizumab (PDR001) and LAG525 in advanced solid tumors and hematologic malignancies. Conference. 2019 ASCO Annual Meeting. Chicago, IL, US.
2019. Cell-free DNA in uveal melanoma: results from the first-in-human trial of mivebresib (ABBV-075). Conference. ASCO Annual Meeting 2019. Chicago, IL, US.
2019. Out of pocket costs and financial toxicity experienced by patients in early phase clinical trials. Conference. 2019 ASCO Annual Meeting. Chicago, IL, US.
2019. Pembrolizumab after two or more lines of prior therapy in patients with advanced small-cell lung cancer (SCLC): Results from the KEYNOTE-028 and KEYNOTE-158 studies. Conference. AACR Annual Meeting 2019. Atlanta, GA, US.
2019. First-in-human Phase I study of M4112, the first dual inhibitor of indoleamine 2,3-dioxygenase-1 and tryptophan 2,3-dioxygenase 2, in patients with advanced solid malignancies. Conference. AACR Annual Meeting 2019. Atlanta, GA, US.
2019. Paired tumor and cfDNA in patients with HER2-mutant solid tumors treated with neratinib reveals convergence of multiple on-target resistance mechanisms: Results from the SUMMIT "Basket" Trial. Conference. AACR Annual Meeting 2019. Atlanta, GA, US.
2019. Pembrolizumab treatment of advanced neuroendocrine tumors: Results from the phase II KEYNOTE-158 study. Conference. 2019 Gastrointestinal Cancers Symposium. San Francisco, CA, US.
2018. Neratinib + fulvstrant for HER2-mutant, HR-positive, metastatic breast cancer: Updated results from the phase 2 SUMMIT trial. Conference. San Antonio Breast Cancer Symposium (SABCS). San Antonio, TX, US.
2018. Neratinib + fulvestrant for HER2-mutant, HR-positive, metastatic breast cancer: Updated results from the phase 2 SUMMIT trial. Conference. San Antonio Breast Cancer Symposium 2018. San Antonio, TX, US.
2018. Combination of subcutaneously administered TLR9 agonist lefitolimod with CTLA-4 checkpoint inhibitor ipilimumab - A phase I trial in patients with advanced solid tumors. Conference. SITC 2018. Washington, DC, US.
2018. Outcomes of patients with gene fusion driven cancers treated on early phase clinical trials. Conference. ASCO Annual Meeting 2018. Chicago, IL, US.
2018. Phase 2 study of pembrolizumab in advanced small-cell lung cancer (SCLC): KEYNOTE-158. Conference. ASCO Annual Meeting 2018. Chicago, IL, US.
2018. Pembrolizumab treatment of advanced cervical cancer: Updated results from the phase 2 KEYNOTE-158 study. Invited. ASCO Annual Meeting 2018. Chicago, IL, US.
2018. TP53 mutations and programmed cell death ligand-1 expression in solid tumors: Associations with clinical factors and outcomes. Conference. ASCO Annual Meeting 2018. Chicago, IL, US.
2018. Longitudinal patient-reported symptom severity and symptom interference with activity-related and mood-related functioning and survival in patients with advanced cancer on early-phase clinical trials of immunotherapeutic or targeted agents. Conference. ASCO Annual Meeting 2018. Chicago, IL, US.
2018. Phase I trial of the triplet M6620 (formerly VX970) + veliparib + cisplatin in patients with advanced solid tumors. Conference. ASCO Annual Meeting 2018. Chicago, IL, US.
2018. Results of the first-in-human study of ABBV-075 (mivebresib), a pan-inhibitor of bromodomain (BD) and extra terminal (BET) proteins, in patients (pts) with relapsed/refractory (R/R) solid tumors. Invited. ASCO Annual Meeting 2018. Chicago, IL, US.
2018. A phase 2, open-label study of the combination of spartalizumab (PDR001) and LAG525 for patients with advanced solid tumors and hematologic malignancies. Conference. ASCO Annual Meeting 2018. Chicago, IL, US.
2018. Phase I study of the pan-HER inhibitor neratinib given in combination with everolimus, palbociclib or trametinib in advanced cancer subjects with EGFR mutation/amplification, HER2 mutation/amplification or HER3/4 mutation. Conference. ASCO Annual Meeting 2018. Chicago, IL, US.
2018. A phase I clinical trial of hepatic arterial infusion of oxaliplatin and oral capecitabine, with or without systemic bevacizumab, for patients with advanced cancer and liver involvement. Conference. ASCO Annual Meeting 2018. Chicago, IL, US.
2018. Precision medicine: Clinical outcomes including long-term survival according to the pathway targeted and treatment period—The IMPACT study. Conference. ASCO Annual Meeting 2018. Chicago, IL, US.
2018. Pharmacodynamics (PD) and genomic profiling of pts treated with cabiralizumab (cabira) + nivolumab (NIVO) provide evidence of on-target tumor immune modulations and support future clinical applications. Conference. ASCO Annual Meeting 2018. Chicago, IL, US.
2018. Gene expression and cytokine modulation in a first in human (FIH) study of a pan BET inhibitor ABBV-075 in solid tumors. Conference. ASCO Annual Meeting 2018. Chicago, IL, US.
2018. Single agent activity of ZW25, a HER2‑targeted bispecific antibody, in heavily pretreated HER2‑expressing cancers. Invited. ASCO Annual Meeting 2018. Chicago, IL, US.
2018. Results of a phase I dose escalation study of ARQ 751 in adult subjects with advanced solid tumors with AKT1, 2, 3 genetic alterations, activating PI3K mutations, PTEN-null, or other known actionable PTEN mutations. Conference. AACR Annual Meeting 2018. Chicago, IL, US.
2018. Hepatotoxicity in advanced cancer patients receiving immune-based cancer treatment. Conference. ASCO-SITC Clinical Immuno-Oncology Symposium. San Francisco, CA, US.
2017. Phase I dose escalation with ZW25, a HER2-targeted bispecific antibody, in patients (pts) with HER2-high breast cancer (BC). Conference. San Antonio Breast Cancer Symposium (SABCS). San Antonio, TX, US.
2017. Phase II study of the PARP inhibitor talazoparib in advanced cancer patients with somatic alterations in BRCA1/2, mutations/deletions in PTEN or PTEN loss, aberrations in other BRCA pathway genes, and germline mutations in BRCA1/2 (not breast or ovarian cancer). Conference. AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics. Philadelphia, PA, US.
2017. Targeting HER2 (ERBB2) amplification identified by next-generation sequencing (NGS) in patients with advanced or metastatic solid tumors. Conference. AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics. Philadelphia, PA, US.
2017. Phase 1/2 study of INCB054329, a bromodomain and extraterminal (BET) protein inhibitor, in patients (pts) with advanced malignancies. Conference. AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics. Philadelphia, PA, US.
2017. Phase IB study to evaluate the safety of selinexor in combination with multiple standard chemotherapy agents in patients with advanced malignancies. Conference. 2017 ASCO Annual Meeting. Chicago, IL, US.
2017. Phase I study of nab-paclitaxel, gemcitabine, and bevacizumab in advanced cancers. Conference. 2017 ASCO Annual Meeting. Chicago, IL, US.
2017. Phase II study for the evaluation of efficacy of pembrolizumab (MK-3475) in patients with cancer of unknown primary. Conference. 2017 ASCO Annual Meeting. Chicago, IL, US.
2017. Pharmaco-kinetics/dynamics (PK/PD) evaluation and individual patient cross-over studies with growth trajectory assessment to adaptively develop ilorasertib. Conference. 2017 ASCO Annual Meeting. Chicago, IL, US.
2017. A phase 1, multicenter, dose-escalation study of PRN1371, an irreversible covalent FGFR1-4 kinase inhibitor, in patients with advanced solid tumors, followed by expansion cohorts in patients with FGFR genetic alterations. Conference. 2017 ASCO Annual Meeting. Chicago, IL, US.
2017. A phase I study of the tolerability, safety, pharmacokinetics and preliminary antitumor effects of KBP-5209, a novel pan-HER inhibitor, in patients with advanced solid tumors. Conference. 2017 ASCO Annual Meeting. Chicago, IL, US.
2017. Initiative for Molecular Profiling and Advanced Cancer Therapy (IMPACT): An MD Anderson precision medicine study. Invited. 2017 ASCO Annual Meeting. Chicago, IL, US.
2017. EphA2 gene targeting using neutral liposomal small interfering RNA (EPHARNA) delivery: A phase I clinical trial. Conference. 2017 ASCO Annual Meeting. Chicago, IL, US.
2017. Phase 1 dose escalation of ZW25, a HER2-targeted bispecific antibody, in patients (pts) with HER2-expressing cancers. Conference. 2017 ASCO Annual Meeting. Chicago, IL, US.
2017. Liquid biopsies of plasma exosomal nucleic acids, plasma cell-free DNA, and survival of patients with advanced cancers. Conference. 2017 ASCO Annual Meeting. Chicago, IL, US.
2017. Pembrolizumab in patients (pts) with PD-L1–positive (PD-L1+) advanced ovarian cancer: Updated analysis of KEYNOTE-028. Invited. 2017 ASCO Annual Meeting. Chicago, IL, US.
2017. Pathogenic variants in DNA damage response (DDR) genes in patients with advanced solid tumors. Conference. 2017 ASCO Annual Meeting. Chicago, IL, US.
2017. Characteristics and outcomes of patients with advanced sarcoma enrolled in early phase immunotherapy trials. Conference. AACR Annual Meeting. Washington, DC, US.
2017. Exploring optimal targeted combination therapies with neratinib for HER2 breast cancer. Conference. AACR Annual Meeting. Washington, DC, US.
2017. Development of a novel prognostic scoring system for patient selection in immune checkpoint inhibitor phase I clinical trials. Conference. AACR Annual Meeting. Washington, DC, US.
2017. Detection of circulating antibodies against KRAS in patients with advanced cancers. Conference. AACR Annual Meeting. Washington, DC, US.
2017. Neratinib in HER2 or HER3 mutant solid tumors: SUMMIT, a global, mulit-histology, open-label, phase 2 'basket' study. Invited. AACR Annual Meeting 2017. Washington, DC, US.
2017. Detection of circulating antibodies against KRAS in patients with advanced cancers. Conference. AACR Annual Meeting 2017. Washington, DC, US.
2017. Neratinib in HER2 or HER3 mutant solid tumors: SUMMIT, a global, mulit-histology, open-label, phase 2 'basket' study. Invited. AACR Annual Meeting. Washington, DC, US.
2017. Mutation enrichment next-generation sequencing for quantitative detection of KRAS mutations in urine cell-free DNA from patients with advanced colorectal and other cancers. Conference. 2017 Gastrointestinal Cancers Symposium. San Francisco, CA, US.
2016. An Immune-Related Gene Expression Profile Delineates Features of the Tumor Microenvironment Required for Clinical Response to PD-1 Blockade. Conference. 31st Annual Meeting of the Society for Immunotherapy of Cancer (SITC). National Harbor, MD, US.
2016. Clinical utilization of precision oncology decision support for genomically-informed cancer therapy. Conference. ASCO Annual Meeting. Chicago, IL, US.
2016. T-cell inflamed phenotype gene expression signatures to predict clinical benefit from pembrolizumab across multiple tumor types. Conference. ASCO Annual Meeting. Chicago, IL, US.
2016. Outcomes of patients with advanced sarcoma enrolled in clinical trials of pazopanib in combination with histone deacetylase, mTOR, Her2, or MEK inhibitors. Conference. ASCO Annual Meeting. Chicago, IL, US.
2016. Clinical next-generation sequencing in sarcomas. Conference. ASCO Annual Meeting. Chicago, IL, US.
2016. Co-occurring genomic alterations and association with progression free survival in BRAFV600 mutated non-melanoma tumors treated with BRAF inhibitor. Conference. ASCO Annual Meeting. Chicago, IL, US.
2016. Pembrolizumab in patients with advanced cervical squamous cell cancer: Preliminary results from the phase Ib KEYNOTE-028 study. Invited. ASCO Annual Meeting. Chicago, IL, US.
2016. A phase 1, multicenter, dose-escalation study of PRN1371, an irreversible covalent FGFR1-4 kinase inhibitor, in patients with advanced solid tumors, followed by expansion cohorts in patients with FGFR genetic alterations. Conference. ASCO Annual Meeting. Chicago, IL, US.
2016. Phase I clinical trial of combination imatinib and ipilimumab in patients with advanced malignancies. Conference. ASCO Annual Meeting. Chicago, IL, US.
2016. Phase I trial of paclitaxel, bevacizumab, and temsirolimus in advanced solid malignancies. Conference. ASCO Annual Meeting. Chicago, IL, US.
2016. Symptom clusters in patients with advanced cancer in an early-phase clinical trials clinic. Conference. ASCO Annual Meeting. Chicago, IL, US.
2016. Updated results for the advanced esophageal carcinoma cohort of the phase 1b KEYNOTE-028 study of pembrolizumab. Conference. ASCO Annual Meeting. Chicago, IL, US.
2016. Safety, toxicity and activity of multi-kinase inhibitor vandetanib in combination with everolimus in advanced solid tumors. Conference. ASCO Annual Meeting. Chicago, IL, US.
2016. Pembrolizumab for advanced papillary or follicular thyroid cancer: preliminary results from the phase 1b KEYNOTE-028 study. Conference. ASCO Annual Meeting. Chicago, IL, US.
2016. Preliminary results for the advanced salivary gland carcinoma cohort of the phase 1b KEYNOTE-028 study of pembrolizumab. Invited. ASCO Annual Meeting. Chicago, IL, US.
2016. Circulating tumor DNA assay performance for detection and monitoring of KRAS mutations in urine from patients with advanced cancers. Conference. AACR Annual Meeting. New Orleans, LA, US.
2016. GSK525762, a selective bromodomain (BRD) and extra terminal protein (BET) inhibitor: results from part 1 of a phase I/II open-label single-agent study in patients with NUT midline carcinoma (NMC) and other cancers. Invited. AACR Annual Meeting. New Orleans, LA, US.
2016. Quantity of KRAS mutations in cell-free DNA is associated with survival of patients with advanced cancers. Conference. AACR Annual Meeting. New Orleans, LA, US.
2016. Updated results for the advanced esophageal carcinoma cohort of the phase Ib KEYNOTE-028 study of pembrolizumab (MK-3475). Invited. ASCO 2016 Gastrointestinal Cancers Symposium. San Francisco, CA, US.
2015. Everolimus, Letrozole and Trastuzumab in estrogen receptor and HER2-positive patients with metastatic breast cancer and other solid tumors: Evaluating synergy and overcoming resistance. Conference. SABCS. San Antonio, TX, US.
2015. Neratinib for ERBB2 mutant, HER2 non-amplified, metaststic breast cancer: Preliminary analysis from a multicenter, open-label, multi-histology phase II basket trial. Conference. 38th San Antonio Breast Cancer Symposium (SABCS). San Antonio, TX, US.
2015. Preliminary efficacy and safety of pembrolizumab (MK-3475) in patients with PD-L1 positive, estrogen receptor-positive (ER+)/HER2-negative advanced breast cancer enrolled in KEYNOTE-028. Conference. 38th Annual CTRC-AACR San Antonio Breast Cancer Symposium (SABCS). San Antonio, TX, US.
2015. Outcomes and genomic mutation profiling results in a subset of patients with gynecologic cancers treated with buparlisib in the Signature Program. Conference. AACR-NCI-EORTC International Conference: Molecular Targets and Cancer Therapeutics. Boston, MA, US.
2015. Outcomes and genomic mutational profiling results in patients with cancers of the head and neck treated with dovitinib in the Signature Program. Conference. AACR-NCI-EORTC International Conference: Molecular Targets and Cancer Therapeutics. Boston, MA, US.
2015. Phase I dose escalation study of temsirolimus in combination with metformin in patients with advanced cancers. Conference. AACR-NCI-EORTC International Conference: Molecular Targets and Cancer Therapeutics. Boston, MA, US.
2015. Circulating cell-free DNA as a marker for response and resistance to BRAF and EGFR inhibition in BRAF-mutated metastatic colorectal cancer. Conference. AACR-NCI-EORTC International Conference: Molecular Targets and Cancer Therapeutics. Boston, MA, US.
2015. Phase I dose escalation study of the oral multi-kinase VEGF inhibitor regorafenib and the anti-EGFR monoclonal antibody cetuximab in patients with advanced solid tumors including colorectal cancer. Conference. AACR-NCI-EORTC International Conference: Molecular Targets and Cancer Therapeutics. Boston, MA, US.
2015. A phase I study of everolimus (mTOR inhibitor) in combination with vandetanib (multikinase inhibitor of VEGFR, EGFR, and RET) in advanced solid tumors including molecularly matched aberrations. Conference. AACR-NCI-EORTC International Conference: Molecular Targets and Cancer Therapeutics. Boston, MA, US.
2015. Checkpoint kinase (CHK) 1/2 inhibitor LY2606368 in a phase I, dose-expansion study in patients (pts) with metastatic squamous cell carcinoma (mSCC) of the anus. Conference. ASCO Annual Meeting. Chicago, IL, US.
2015. Phase Ib study of vemurafenib in combination with irinotecan and cetuximab in patients with BRAF-mutated metastatic colorectal cancer and advanced cancers. Conference. 2015 ASCO Annual Meeting. Chicago, IL, US.
2015. Successful implementation of a novel trial model: The Signature Program. Invited. ASCO Annual Meeting. Chicago, IL, US.
2015. Low frequency KRAS G12/13 mutations in urine cell-free (cf) DNA from patients with BRAF V600E-mutant advanced cancers. Conference. ASCO Annual Meeting. Chicago, IL, US.
2015. Phase I study of combination vemurafenib, carboplatin, and paclitaxel in patients (pts) with BRAF-mutant advanced cancer. Conference. ASCO Annual Meeting. Chicago, IL, US.
2015. Phase I study of combination vemurafenib, carboplatin, and paclitaxel in patients (pts) with BRAF-mutant advanced cancer. Invited. ASCO Annual Meeting. Chicago, IL, US.
2015. Prospective study comparing outcomes in patients with advanced malignancies on molecular alteration-matched versus non-matched therapy. Conference. ASCO Annual Meeting. Chicago, IL, US.
2015. Validation of the Royal Marsden Hospital (RMH) prognostic score in 100 patients with advanced sarcoma enrolled in early phase clinical trials at a major cancer center. Conference. ASCO Annual Meeting. Chicago, IL, US.
2015. Pembrolizumab (MK-3475) for patients (pts) with advanced esophageal carcinoma: Preliminary results from KEYNOTE-028. Conference. ASCO Annual Meeting. Chicago, IL, US.
2015. Phase I combination of pazopanib and everolimus in PIK3CA mutation positive/PTEN loss patients with advanced solid tumors refractory to standard therapy. Conference. ASCO Annual Meeting. Chicago, IL, US.
2015. Genomic mutation profiling (GMP) and clinical outcome of patients treated with buparlisib (PI3K inhibitor) in the “Signature” program. Conference. ASCO Annual Meeting. Chicago, IL, US.
2015. Phase I study of the mTOR inhibitor sirolimus and the HDAC inhibitor vorinostat in patients with advanced malignancies. Conference. ASCO Annual Meeting. Chicago, IL, US.
2015. Sleep quality and its association with fatigue, symptom burden, and mood in patients with advanced cancer in a phase I clinic. Conference. ASCO Annual Meeting. Chicago, IL, US.
2015. Phase II Study of the PARP Inhibitor Talazoparib (BMN-673) in Advanced Cancer Patients with Somatic Alterations in BRCA1/2, Mutations/Deletions in PTEN or PTEN loss, a Homologous Recombination Defect, Mutations/Deletions in Other BRCA Pathway Genes and Germline Mutation s in BRCA1/2 (not breast or ovarian cancer). Conference. ASCO Annual Meeting. Chicago, IL, US.
2015. Phase I study of combination of crizotinib (C) and dasatinib (D) in patients (pts) with advanced cancer. Conference. ASCO Annual Meeting. Chicago, IL, US.
2015. Efficacy, safety, biomarkers, and phase II dose modeling in a phase I trial of the oral selective c-Met inhibitor tepotinib (MSC2156119J). Conference. ASCO Annual Meeting. Chicago, IL, US.
2015. Checkpoint kinase (CHK) 1/2 inhibitor LY2606368 in a phase I dose-expansion study in patients with squamous cell carcinoma of the head and neck. Invited. AACR Annual Meeting. Philadelphia, PA, US.
2015. Overcoming BRAF/MEK resistance using vemurafenib with crizotinib or sorafenib in patients with BRAF-mutant advanced cancers: phase I study. Conference. AACR Annual Meeting. Philadelphia, PA, US.
2015. Rapid, automated BRAF mutation testing of cell-free DNA from plasma of patients with advanced cancers using the novel Idylla platform. Conference. AACR Annual Meeting. Philadelphia, PA, US.
2015. Mulitplex KRAS G12/G13 mutation testing of 16ng of unamplified cell-free DNA from plasma of patients with advanced cancers using Droplet Digital PCR. Conference. AACR Annual Meeting. Philadelphia, PA, US.
2015. Evolution of phase 1 trials for patients with advanced pancreatic cancer: An update on the experience from MD Anderson Cancer Center. Conference. ASCO Gastrointestinal Cancers Symposium. San Francisco, CA, US.
2015. Colorectal cancer (CRC) cohort analysis of patients treated with buparlisib in a distinctive tissue-agnostic trial model for molecularly preselected tumors. Conference. ASCO Gastrointestinal Cancers Symposium. San Francisco, CA, US.
2014. Anastrozole and everolimus in hormone receptor-positivie metastatic breast cancer: Activity and Associations with Molecular Alterations in the PI3K/AKT/mTOR Pathway. Conference. SABCS. San Antonio, TX, US.
2014. The signature program, a series of tissue-agnostic, genetic aberration specific signal-finding trials. Conference. Mayo Individualizing Medicine 2014 Conference. Rochester, Minnesota, US.
2014. Eliciting early response signals from first in human clinical trials and validation of prognostic scores in aggressive biology bone cancers: the MD Anderson experience. Poster. ASCO Annual Meeting 2014. Chicago, IL, US.
2014. Eliciting early-response signals from first-in-human clinical trials and validation of prognostic scores in aggressive biology bone cancers: The MD Anderson experience. Conference. ASCO Annual Meeting 2014. Chicago, IL, US.
2014. A phase I trial of pazopanib and vorinostat: The role of TP53 mutations. Conference. ASCO Annual Meeting. Chicago, IL, US.
2014. A phase I trial of vandetanib (multikinase inhibitor of EGFR, VEGFR and RET) in combination with everolimus (mTOR inhibitor) in patients with advanced malignancies. Conference. ASCO Annual Meeting. Chicago, IL, US.
2014. Targeting argininosuccinate synthetase-deficient advanced solid tumors in a phase I trial of ADI-PEG20 plus cisplatin. Conference. ASCO Annual Meeting. Chicago, IL, US.
2014. PI3K/AKT/mTOR genomic alterations in 94 patients with metastatic breast cancer in the phase I clinic at MD Anderson: Prevalence and association with response. Conference. ASCO Annual Meeting. Chicago, IL, US.
2014. Results of a phase I trial combining ridaforolimus (mTOR inhibitor) and MK-0752 (Notch inhibitor) in patients with advanced solid tumors. Conference. ASCO Annual Meeting. Chicago, IL, US.
2014. Phase 1 study of ATR-101 in adrenocortical carcinoma (ACC): ATR-101-001. Conference. ASCO Annual Meeting. Chicago, IL, US.
2014. The signature program, a series of tissue-agnostic, mutation-specific signal finding trials. Conference. ASCO Annual Meeting. Chicago, IL, US.
2014. Rechallenge with anti-EGFR–based therapy in metastatic colorectal cancer: Impact of intervening time interval and prior anti-EGFR response. Conference. ASCO Annual Meeting. Chicago, IL, US.
2014. Safety/efficacy of MK-8669 (ridaforolimus) plus MK-2206 (AKT inhibitor) in patients with advanced breast cancer with low RAS signature and PTEN deficient prostate cancer. Poster. ASCO Annual Meeting 2014. Chicago, Illinois, US.
2014. Results of the first-in-human phase I trial assessing MSC2156119J (EMD 1214063), an oral selective c-Met inhibitor, in patients (pts) with advanced solid tumors. Conference. ASCO Annual Meeting. Chicago, IL, US.
2014. Phase 1B study of vemurafenib in combination with irinotecan and cetuximab in patients with BRAF-mutated advanced cancers and metastatic colorectal cancer. Conference. ASCO Annual Meeting. Chicago, IL, US.
2014. Clinical next-generation sequencing to identify actionable alterations in a phase I program. Conference. ASCO Annual Meeting. Chicago, IL, US.
2014. Outcomes of pediatric cancer patients enrolled in phase 1 clinical trials designed for adults: Experience from a major cancer center. Conference. ASCO Annual Meeting. Chicago, IL, US.
2014. BRAF mutation testing in cell-free DNA from plasma of patients with advanced cancers using a novel, rapid, automated molecular diagnostics prototype platform (Idylia™). Conference. AACR Annual Meeting. San Diego, CA, US.
2014. Preclinical pharmacology and clinical efficacy of AZD9150 (ISIS-STAT3Rx), a potent next-generation antisense oligonucleotide inhibitor of STAT3. Conference. AACR Annual Meeting. San Diego, CA, US.
2014. Digital droplet PCR detection and monitoring of BRAF mutations in cell-free urinary DNA of patients with metastatic cancers or Erdheim-Chester disease. Conference. AACR Annual Meeting. San Diego, CA, US.
2014. MSC2156119J (EMD 1214063), an oral selective c-Met inhibitor, in patients with advanced solid tumors: results of the first-in-human phase I trial. Invited. AACR Annual Meeting. San Diego, CA, US.
2014. Differential effect of PIK3CA mutations and PTEN loss in patients with advanced endometrial cancers on matched therapy. Conference. AACR Annual Meeting. San Diego, CA, US.
2014. Phase I study of 5-azacytidine and oxaliplatin in patients with advanced cancers relapsed or refractory to platinum compounds. Conference. AACR Annual Meeting. San Diego, CA, US.
2014. c-Met abnormalities in patients with genitourinary (GU) malignancies and outcomes with c-MET inhibitors. Conference. ASCO Genitourinary Cancers Symposium. Orlando, FL, US.
2012. PTEN assessment and PI3K/mTOR inhibitors: Importance of simultaneous assessment of MAPK pathway aberrations. Invited. ASCO Annual Meeting. Chicago, IL, US.
2012. Targeted agents matched with tumor molecular aberrations: Review of 160 patients with advanced melanoma treated in a phase I clinic. Conference. ASCO Annual Meeting. Chicago, IL, US.
2012. First-in-human phase I dose-escalation study of the oral selective C-met inhibitor EMD 1204831 in patients with advanced solid tumors. Conference. ASCO Annual Meeting. Chicago, IL, US.
2012. p53 mutations in advanced cancers: Clinical characteristics and outcomes in a phase I setting. Conference. ASCO Annual Meeting. Chicago, IL, US.
2012. NRAS mutations in patients with advanced cancers treated with target-based therapies in early-phase clinical trials. Conference. ASCO Annual Meeting. Chicago, IL, US.
2012. Target-based therapeutic matching in early-phase clinical trials in patients with advanced colorectal cancer and PIK3CA mutations. Poster. 2012 Gastrointestinal Cancers Symposium. Chicago, IL, US.
2011. Pharmacokinetic assessment of drug–drug interaction potential when rosiglitazone or combined oral contraceptive is co-administered with vismodegib in patients with locally advanced or metastatic solid tumors. Conference. AACR-NCI-EORTC Molecular Targets and Cancer Therapeutics. San Francisco, CA, US.
2011. Personalized Medicine in a Phase I Clinical Trials Program: The M. D. Anderson Cancer Center Initiative. Invited. 2011 ASCO Annual Meeting. Chicago, IL, US.
2011. An umbrella protocol for histology-independent, phase I modular study based on EGFR mutation status: Using erlotinib alone or in combination with cetuximab, bortezomib, or dasatinib to overcome resistance. Poster. 2011 ASCO Annual Meeting. Chicago, IL, US.
2011. Phase I study of anti-VEGF monoclonal antibody bevacizumab and HDAC inhibitor valproic acid in patients with advanced cancers. Poster. 2011 ASCO Annual Meeting. Chicago, IL, US.
2011. Survival of 1,181 patients in a phase I clinic: The University of Texas M. D. Anderson Cancer Center experience. Poster. 2011 ASCO Annual Meeting. Chicago, IL, US.
Longitudinal monitoring of BRAF V600E mutation in urinary cell-free DNA of patients with metastatic cancers using droplet digital PCR. Poster. ASCO Annual Meeting 2014. Chicago, IL, US.
Phase I study of Everolimus (mTOR inhibitor) in combination with Vandetanib (multikinase inhibitor of EGFR,VEGFR,RET) in children, adolescents, and young adults with advanced solid tumors. Conference. AACR Annual Meeting. Fort Lauderdale, FL, US.
Antitumor activity and safety of pembrolizumab in patients (pts) with PD-L1 positive advanced ovarian cancer: interim results from a phase 1b Study. Conference. 2015 ASCO Annual Meeting. San Francisco, California, US.

International Presentations

2025. Immune Complex Profiling Identifies Biomarkers of Response to Immune Checkpoint Inhibitors Across Cancers. Poster. ESMO Immuno-Oncology Congress. London, GB.
2025. Concordance analysis of DNA and RNA profiling: Results of the MD Anderson IMPACT2 study in precision oncology. Poster. ESMO Congress 2025. Berlin, DE.
2025. MD Anderson IMPACT2 study: Mutation enrichment analysis by tumor type and gene co-occurrence patterns in patients with DDR and non-DDR alterations. Poster. ESMO Congress 2025. Berlin, DE.
2025. Phase I study of intratumoral administration of JNJ-87704916, an oncolytic virus, as monotherapy and in combination with cetrelimab in advanced solid tumors. Poster. ESMO Congress 2025. Berlin, DE.
2025. First-in-class CBL-B inhibitor NX-1607: Phase Ia data in patients with advanced solid tumors. Poster. ESMO Congress 2025. Berlin, DE.
2025. A phase I/II study of a first-in-class non-cellular antibody-drug conjugate, micvotabart pelidotin (MICVO), in combination with pembrolizumab in select advanced solid tumors. Poster. ESMO Congress 2025. Berlin, DE.
2024. First-in-human, phase 1 study of a selective RET inhibitor, LOXO-260, in patients with RET inhibitor refractory, RET-altered cancers. Poster. 36th EORTC-NCI-AACR. Barcelona, ES.
2024. Poly(ADP-Ribose) Polymerase (PARP) inhibition in metastatic breast cancer: comparison of therapeutic outcomes between patients with BRCA1/2 mutations and other alterations. Poster. 36th EORTC-NCI-AACR. Barcelona, ES.
2024. Final Results of IMPACT 2, a Randomized Study Evaluating Molecular Profiling and Targeted Agents in Metastatic Cancer at MD Anderson Cancer Center. Poster. ESMO Congress 2024. Barcelona, ES.
2024. Preliminary results from a Phase 1, first-in-human study of DS-9606a, a Claudin 6 (CLDN6)-directed antibody–drug conjugate (ADC), in patients (pts) with tumor types known to express CLDN6. Invited. ESMO Congress 2024. Barcelona, ES.
2024. Phase I Study of Pamiparib and Cabozantinib in Patients with Metastatic Solid Tumors Harboring Homologous Recombination Deficiency (HRD). Poster. ESMO Congress 2024. Barcelona, ES.
2023. A Phase 1 Study Exploring the Safety and Tolerability of the Small-Molecule PD-L1 Inhibitor INCB099280 in Select Advanced Solid Tumors. Conference. ESMO Immuno-Oncology Symposium. Geneva, CH.
2023. Ifinatamab deruxtecan (I-DXd; DS-7300) in patients with advanced solid tumors: Updated clinical and biomarker results from a phase I/II study. Conference. ESMO Congress 2023. Madrid, ES.
2023. NCI10221: Phase II Multicenter Biomarker Driven Combination Trial of Copanlisib and Nivolumab in Patients with Molecularly-selected Advanced Solid Tumors (BaCoN). Conference. ESMO Congress 2023. Madrid, ES.
2023. Tinengotinib in Patients with Advanced, Fibroblast Growth Factor Receptor (FGFR) inhibitor Refractory/Relapsed Cholangiocarcinoma. Invited. ESMO Congress 2023. Madrid, ES.
2022. Correlation of clinical, genomic and hematological parameters with ATR inhibitor (ATRi) outcomes in phase I/II clinical trials. Conference. ESMO Congress 2022. Paris, FR.
2022. DS-7300 (B7-H3 DXd Antibody Drug Conjugate [ADC]) Shows Durable Antitumor Activity in Advanced Solid Tumors: Extended Follow-up of a Phase 1/2 Study. Invited. ESMO Congress 2022. Paris, FR.
2021. A phase I/II multicenter, first-in-human study of DS-7300 (B7-H3 DXd-ADC) in patients (pts) with advanced solid tumors. Invited. ESMO Congress 2021. Paris, FR.
2020. Selinexor in combination with carboplatin and pemetrexed (CP) in patients with advanced or metastatic solid tumors: Results of an open label, single-center, multi-arm phase Ib study. Conference. ESMO Asia Virtual Congress. Singapore, SG.
2020. Selinexor in combination with standard chemotherapy in patients with advanced solid tumours: Results of an open label, single-center, multi-arm phase Ib study. Invited. ESMO Asia Virtual Congress 2020. Virtual Presentation, SG.
2019. Association of tumor mutational burden with outcomes in patients with select advanced solid tumors treated with pembrolizumab in KEYNOTE-158. Invited. ESMO Congress 2019. Barcelona, ES.
2019. Pembrolizumab in Advanced Rare Cancers. Conference. ESMO Congress 2019. Barcelona, ES.
2019. Pembrolizumab in Patients with MSI-H Advanced Endometrial Cancer from the KEYNOTE-158 Study. Conference. ESMO Congress 2019. Barcelona, ES.
2019. A phase I, open-label study of GSK1795091 administered in combination with immunotherapies in participants with advanced solid tumours (NCT03447314). Conference. ESMO Congress 2019. Barcelona, ES.
2019. Precision medicine: Preliminary results from the initiative for molecular profiling and advanced cancer therapy 2 (IMPACT 2) study. Invited. ESMO Congress 2019. Barcelona, ES.
2019. Treating HER2-mutant advanced biliary tract cancer with neratinib: benefits of HER2-directed targeted therapy in the phase 2 SUMMIT 'basket' trial. Invited. ESMO World Congress on Gastrointestinal Cancer. Barcelona, ES.
2019. Update on the phase II SUMMIT trial: Neratinib + fulvestrant forHER2-mutant, HR-positive, metastatic breast cancer. Conference. ESMO Breast Cancer Annual Congress. Berlin, DE.
2018. A Phase 1 Dose Escalation Study of ARQ 751 in Adult Patients with Advanced Solid Tumors with AKT1, 2, 3 Genetic Alterations, Activating PI3K Mutations, PTEN-null, or Other Known Actionable PTEN Mutations. Conference. 30th EORTC-NCI-AACR Molecular Targets and Cancer Therapeutics Symposium. Dublin, IE.
2018. Circulating tumor cell-free DNA correlates with the total tumor volume and survival in patients with advanced cancers. Conference. 30th EORTC-NCI-AACR Molecular Targets and Cancer Therapeutics Symposium. Dublin, IE.
2018. Efficacy of pembrolizumab in patients with cutaneous squamous cell carcinoma. Conference. 30th EORTC-NCI-AACR Molecular Targets and Cancer Therapeutics Symposium. Dublin, IE.
2017. Pembrolizumab for patients with PD-L1-positive advanced carcinoid. Conference. ESMO 2017 Congress. Madrid, ES.
2017. Pembrolizumab for patients with PD-L1-positive advanced carcinoid or pancreatic neuroendocrine tumors: Results from the KEYNOTE-0028 study. Conference. ESMO 2017 Congress. Madrid, ES.
2017. Relationship of PD-L1 and T-cell inflamed gene expression profile (GEP) to clinical response in a multicohort trial of solid tumors (KEYNOTE [KN] 028). Conference. ESMO 2017 Congress. Madrid, ES.
2017. Phase 1 dose-escalation study of single-agent ZW25, a HER2-targeted bispecific antibody, in patients (pts) with HER2-expressing cancers. Conference. ESMO 2017 Congress. Madrid, ES.
2017. Dose escalation study of vemurafenib with crizotinib or sorfenib in patients with BRAF-mutated advance cancers. Conference. ESMO 2017 Congress. Madrid, ES.
2017. Dose escalation study of vemurafenib with crizotinib or sorfenib in patients with BRAF-mutated advance cancers. Conference. ESMO 2017 Congress. Madrid, ES.
2017. Dose escalation study of vemurafenib with crizotinib or sorfenib in patients with BRAF-mutated advance cancers. Conference. ESMO 2017 Congress. Madrid, ES.
2017. Targeted methylation sequencing of plasma cell-free DNA identifies patients with advanced breast, colorectal, non-small cell lung cancer, melanoma with poor outcomes. Conference. ESMO 2017 Congress. Madrid, ES.
2017. Evaluating for pseudoprogression in colorectal and pancreatic tumors treated with immunotherapy. Conference. ESMO World Congress on Gastrointestinal Cancer 2017. Barcelona, ES.
2016. Drug development in the MD Anderson Cancer Center (MDACC) Clinical Translational Research Center (CTRC) - 2011-2015: The challenge of precision medicine in a very broad playing field. Conference. 28th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics. Munich, DE.
2016. Incidence of immune-related adverse events in patients who received immunotherapy and radiographic analysis to predict pneumonitis. Conference. 28th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics. Munich, DE.
2016. Cancer-related internet use in patients with advanced cancer in a phase I clinical trials clinic. Conference. 28th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics. Munich, DE.
2016. Pharmacokinetics (PK) of CRLX101 administered weekly in patients (pts) with advanced solid tumors. Conference. ESMO 2016 Congress. Copenhagen, DK.
2016. A dose-escalation study of weekly intravenous CRLX301 in patients with advanced solid tumor malignancies. Conference. ESMO 2016 Congress. Copenhagen, DK.
2016. Evaluation of weekly dosing of CRLX101 alone and in combination with bevacizumab (bev) in patients (pts) with advanced solid tumors. Conference. ESMO 2016 Congress. Copenhagen, DK.
2016. Pembrolizumab for patients with advanced prostate adenocarcinoma: Preliminary results from the KEYNOTE-028 study. Conference. ESMO 2016 Congress. Copenhagen, DK.
2014. BRAF mutation testing in cell-free DNA from plasma of patients with advanced cancers using a novel, rapid, automated molecular diagnostics prototype platform (Idylia™). Invited. 26th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics. Barcelona, ES.
2014. Feasibility of large-scale genomic testing to facilitate enrollment on genomically-matched clinical trials. Invited. 26th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics. Barcelona, ES.
2014. First-in-human phase I trial assessing the highly selective c-Met inhibitor MSC2156119J (EMD 1214063) in patients with advanced solid tumors. Conference. ESMO 2014 Congress. Madrid, ES.
2012. Phase I dose-escalation study of oral selective c-Met inhibitor EMD 1214063 in patients with advanced solid tumors. Invited. ESMO Congress 2012. Vienna, AT.

Less

Grant & Contract Support

Date:	2026 - Present
Title:	A phase 1B/2 trial investigating the safety and efficacy of oral AMXT-1501 dicaprate and oral DFMO in combination with standard of care in patients with advanced solid tumors who progressed after prior therapies
Funding Source:	Aminex Therapeutics, Inc
Role:	PI
ID:	2025-1512 \| AMXT-1501

Date:	2026 - Present
Title:	A phase 1B/2 trial investigating the safety and efficacy of oral AMXT-1501 dicaprate and oral DFMO in combination with standard of care in patients with advanced solid tumors who progressed after prior therapies
Funding Source:	Aminex Therapeutics, Inc
Role:	PI
ID:	2025-1512 \| AMXT-1501

Date:	2026 - Present
Title:	A first-in-human, phase 1, multi-center, open-label, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary evidence of antitumor activity of IDOV-Immune in adult participants with advanced solid tumors
Funding Source:	ViroMissile, Inc
Role:	PI
ID:	2025-1777 \| IDOV-Immune

Date:	2025 - Present
Title:	A Phase 1 Open-label Study to Investigate PF-08046876 in Adult Participants with Advanced Solid Tumors
Funding Source:	Pfizer Inc
Role:	PI
ID:	2025-0841 \| PF-08046876

Date:	2025 - Present
Title:	Phase I open-label dose escalation trial of BI 3923948 monotherapy and in combination with an anti-PD-1 mAb in patients with advanced, unresectable and/or metastatic solid tumors
Funding Source:	Boehringer Ingelheim International GmBH
Role:	PI
ID:	2025-1715 \| BI 3923948

Date:	2025 - Present
Title:	A Phase 1/2a Dose Escalation and Expansion Study of the Safety, Tolerability, and Preliminary Clinical Activity of 177Lu-BetaBart, a 177Lu-Labeled Anti-B7-H3 Monoclonal Antibody, in Patients with Relapsed/Refractory, Locally Advanced Inoperable, or Metastatic Solid Tumors
Funding Source:	Radiopharm Theranostics Ltd
Role:	PI
ID:	2025-0758 \| 177Lu-BetaBart

Date:	2025 - Present
Title:	Master Rollover Protocol for Continued Assessment of Study Drug LOXO-260
Funding Source:	Eli Lilly and Company
Role:	PI
ID:	2025-0610 \| I8I-MC-JYAA

Date:	2025 - 2032
Title:	A Phase 1 Dose-Escalation Study of SLV-324 in Subjects with Metastatic Solid Tumors
Funding Source:	Solve Therapeutics
Role:	PI
ID:	2025-0691 \| SLV-324-01Tx

Date:	2025 - 2026
Title:	A First-in-Human, Phase 1a/1b Trial to Assess the Safety, Tolerability and Preliminary Efficacy of LY4175408, an Antibody Drug Conjugate Targeting Protein Tyrosine Kinase 7-Expressing Tumor Cells, in Participants with Selected Advanced Solid Tumors
Funding Source:	Eli Lilly & Co
Role:	PI
ID:	2025-0729 \| J6D-MC-JSDA

Date:	2025 - 2032
Title:	A phase I open-label, multicenter study to evaluate the safety, pharmacokinetics, and activity of AUBE00 in patients with solid tumors
Funding Source:	Chugai Pharmaceutical Co., Ltd
Role:	PI
ID:	2025-0325 \| AUB101CT

Date:	2024 - Present
Title:	Phase 1 Open-Label Study to Evaluate Safety and Determine the Maximum Tolerated Dose of Ibrx-042 in Participants with HPV-Associated Tumors
Funding Source:	Immunity Bio, Inc
Role:	PI
ID:	2024-1006 \| IBRX-042

Date:	2024 - 2031
Title:	A Phase 2, Open-label, Multicenter Study of IBI363 (PD1-IL2m) in Subjects with Advanced Solid Malignancies
Funding Source:	Innovent Biologics (Suzhou) Co., Ltd
Role:	PI
ID:	2024-0216 \| IBI363

Date:	2024 - 2031
Title:	An Open Label, Multicenter Rollover Study for Continued Characterization of Safety and Tolerability of TT-00420 (tinengotinib) Tablet Monotherapy in Adult Patients with Advanced Solid Tumors
Funding Source:	TransThera Sciences, Inc
Role:	PI
ID:	2024-0149

Date:	2024
Title:	SPIND - Use of Drug PF-07265807 in a Patient with Ovarian Cancer
Funding Source:	Pfizer
Role:	PI
ID:	2024-0195

Date:	2024 - 2031
Title:	A Phase 1/2, Open-label, Multi-center, First-in-human Study of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Anti-tumor Activity of STX-001 Delivered by Intratumoral Injection in Patients with Advanced Solid Tumors as a Monotherapy or in Combination with Pembrolizumab
Funding Source:	Strand Therapeutics, Inc
Role:	Co-PI
ID:	2023-1060

Date:	2024 - 2031
Title:	Phase I open-label, dose escalation trial of BI 1831169 monotherapy and in combination with an anti-PD-1 mAb in patients with advanced or metastatic solid tumors
Funding Source:	Boehringer Ingelheim
Role:	PI
ID:	2023-0985

Date:	2024 - Present
Title:	A Phase Ia/Ib Open-Label, Dose-Escalation Study to Evaluate the Safety and Pharmacokinetics of ROSE12 as a Single Agent and in Combination with Other Anti-Tumor Agents in Patients with Locally Advanced or Metastatic Solid Tumors
Funding Source:	Chugai Pharma
Role:	PI
ID:	2023-0152 \| RSE101CT

Date:	2024
Title:	A Randomized Trial of Neratinib, a Pan-Erbb Inhibitor, Alone or In Combination with Palbociclib, A Cdk4/6 Inhibitor, in Patients with Her2+ Gynecologic Cancers and Other Solid Tumors
Funding Source:	NRG Oncology
Role:	PI
ID:	2024-0156 \| EAY191-N5

Date:	2024
Title:	A Phase 1/2 Study of PRO1107 in Patients with Advanced Solid Tumors
Funding Source:	ProfoundBio US Co
Role:	PI
ID:	2023-0894 \| PRO1107

Date:	2024
Title:	SPIND: Use of ABM-1310 and Cobimetinib in a Patient with Papillary Thyroid Carcinoma
Funding Source:	AMB Therapeutics
Role:	PI
ID:	2024-0222

Date:	2024
Title:	SPIND: Use of ABM-1310 in a Patient with Glioblastoma
Funding Source:	ABM Therapeutics
Role:	PI
ID:	2024-0224

Date:	2024
Title:	SPIND: Use of ABM-1310 in a Patient with Metastatic Malignant Melanoma
Funding Source:	ABM Therapeutics
Role:	PI
ID:	2024-0203

Date:	2024 - 2028
Title:	Phase 1 Study of Intratumoral Administration of JNJ-87704916, an Oncolytic Virus, as Monotherapy and in Combination for Advanced Solid Tumors
Funding Source:	Johnson & Johnson
Role:	PI
ID:	2023-0859 \| JNJ-87704916

Date:	2023 - 2030
Title:	A Phase 1, first-in-human, open-label, multicenter study of JZP898 as monotherapy and in combination with pembrolizumab in participants with advanced or metastatic solid tumors
Funding Source:	Jazz Pharmaceuticals
Role:	PI
ID:	2023-0580 \| JZP898

Date:	2023
Title:	A Phase 1/2, Open Label, Dose Escalation And Expansion Study of Tac-001 In Patients With Select Advanced or Metastatic Solid Tumors
Funding Source:	Tallac Therapeutics, Inc
Role:	PI
ID:	2023-0598 \| TAC-001

Date:	2023 - 2030
Title:	A Phase 1 Dose-Escalation and Expansion Study of Intratumorally Administered ONM-501 Alone and in Combination with pembrolizumab in Patients with Advanced Solid Tumors and Lymphomas
Funding Source:	OncoNano Medicine, Inc
Role:	PI
ID:	2023-0302 \| ON-5001

Date:	2023 - Present
Title:	A Phase I Open-Label, Multicenter Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of Sail66 in Patients with CLDN6-Positive Locally Advanced or Metastatic Solid Tumors
Funding Source:	Chugai Pharma
Role:	PI
ID:	2023-0036 \| SAL101JG

Date:	2023 - Present
Title:	A Phase 1 Open-label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of CLN-418 in Subjects with Advanced Solid Tumors
Funding Source:	Cullinan Oncology, Inc
Role:	PI
ID:	2023-0501

Date:	2023 - 2029
Title:	A Modular, Open-label, Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of EP0031in Patients with Advanced RET-altered Malignancies
Funding Source:	Theradex Oncology
Role:	PI
ID:	2022-0476 \| EP0031-101

Date:	2023 - 2024
Title:	A Phase 1 Study of BET Bromodomain Inhibitor ZEN003694 in Combination with the CDK4/6 Inhibitor Abemaciclib in Patients with NUT Carcinoma and Other Solid Tumors
Funding Source:	NIH/NCI
Role:	PI
ID:	2023-0282 \| NCI 10509

Date:	2023 - 2030
Title:	A Phase 1a, Dose Escalation, Safety and Tolerability Study of NX-1607, a Casitas B-lineage lymphoma proto-oncogene (CBL-B) inhibitor, in Adults with Advanced Malignancies, with Phase 1b Expansion in Select Tumor Types
Funding Source:	Nurix
Role:	PI
ID:	2022-0617 \| Nurix NX-1607-101

Date:	2023 - 2030
Title:	A Phase I Trial of TGN-S11 In Patients with Human Papillomavirus (HPV)-Associated Relapsed, Resistant or Metastatic Cancer
Funding Source:	Toragen Therapeutics, Inc
Role:	PI
ID:	2023-0108

Date:	2023 - 2024
Title:	A Phase I First-in-human, Open-label, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0237 in Adult Participants with Advanced Solid Tumors
Funding Source:	Jiangsu Simcere Pharmaceutical Co., Ltd
Role:	PI
ID:	2022-1016

Date:	2023 - 2025
Title:	A Phase 1, First-in-Human, Dose-Finding and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Activity of XmAb®808 in Combination with Pembrolizumab in Selected Advanced Solid Tumors
Funding Source:	Xencor, Inc
Role:	PI
ID:	2022-0762

Date:	2023 - 2030
Title:	A Phase I, First-In-Human, Multicenter, Open Label, Dose Escalation and Dose Expansion Study to Evaluate the Safety and Efficacy of ABM-168 Administered Orally in Adult Patients with Advanced Solid Tumors
Funding Source:	ABM Therapeutics Corp
Role:	PI
ID:	2022-0763 \| ABM168X1101

Date:	2023 - 2025
Title:	An open-label, Phase I dose escalation and expansion trial to investigate safety and efficacy of BI 1821736 in patients with advanced solid tumors
Funding Source:	Boehringer Ingelheim
Role:	PI
ID:	2023-0987 \| BI1821736

Date:	2023 - 2024
Title:	A Phase 1/2 Study of the Bromodomain Inhibitor ZEN003694 in Combination with Etoposide/Platinum in Patients with NUT Carcinoma
Funding Source:	NIH/NCI
Role:	Principal Investigator-MDACC
ID:	2022-0898/NCI10507

Date:	2022 - 2029
Title:	A Phase 1 Study of EP31670, a Dual BET and CBP/p300 Inhibitor in Patients with Targeted Advanced Solid Tumors
Funding Source:	Epigenetix Inc
Role:	PI
ID:	2022-0340

Date:	2022 - 2029
Title:	A Phase 1, Open-Label, Multicenter Study of INCA32459 in Participants with Select Advanced Malignancies
Funding Source:	Incyte Corporation
Role:	PI
ID:	2022-0671

Date:	2022 - 2029
Title:	A Phase I Trial of SIM1811-03 in Subjects with Advanced Solid Tumors and Cutaneous T-cell Lymphoma
Funding Source:	Jiangsu Simcere Pharmaceutical Co., Ltd
Role:	PI
ID:	2022-0569

Date:	2022 - 2029
Title:	A Phase 1 Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of JCXH-211 Intratumoral Injection in Patients with Malignant Solid Tumors
Funding Source:	Immorna Biotherapeutics, Inc
Role:	PI
ID:	2022-0194

Date:	2022 - 2029
Title:	An Open-Label, Multicenter, Phase 1 Study of RP3 as a Single Agent and in Combination with PD-1 Blockade in Patients with Solid Tumors
Funding Source:	Replimune
Role:	PI
ID:	2022-0513

Date:	2022 - 2029
Title:	A Phase 1, first-in-human study of DS-9606a in patients with tumor types known to express claudin-6 (CLDN6)
Funding Source:	Daiichi Sankyo, Inc
Role:	PI
ID:	2022-0338

Date:	2022 - 2029
Title:	A Phase I, First-in-Human, Open-Label, Dose Escalation and Expansion Study of PT199 Administered Alone and in Combination with a PD-1 Inhibitor in Adult Patients with Advanced Solid Tumors
Funding Source:	Phanes Therapeutics
Role:	PI
ID:	2022-0346

Date:	2022 - 2029
Title:	A Phase 1B/2A Study of the Safety, Tolerability and Initial Efficacy of Oral AMXT 1501 Dicaprate and Intravenous Difluoromethylornithine (DFMO) in Patients with Cancer
Funding Source:	Aminex Therapeutics, Inc
Role:	PI
ID:	2022-0198

Date:	2022 - 2029
Title:	An Open-label, Single-arm, Multi-center Phase I/IIA Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of SHR-A1904 in Subjects with Advanced Solid Tumors Expressing Claudin 18.2
Funding Source:	Hengrui Pharmaceuticals, Co., Ltd./LabCorp
Role:	PI
ID:	2021-1205

Date:	2022 - 2024
Title:	A Phase 1 Study of ZEN003694 in Combination with Binimetinib in Solid Tumors with RAS Pathway Alterations and Triple Negative Breast Cancer
Funding Source:	NIH/NCI
Role:	PI
ID:	2022-0244/NCI 10449

Date:	2022 - 2029
Title:	Loxo Oncology, Inc. on behalf of Eli Lilly and Company - LOXO-NGR-21001, A Phase 1 Study of Oral LOXO-260 in Patients with RET Fusion-Positive Solid Tumors, Medullary Thyroid Cancer, and Other Tumors with RET Activation Refractory to Selective RET Inhibitors
Funding Source:	Loxo Oncology,Inc
Role:	PI
ID:	2022-0098

Date:	2022 - 2029
Title:	A Phase 1/2, First-in-Human, Open Label, Dose Escalation Study of a Cancer-Specific Plectin (CSP)-Targeting Functional Antibody in Solid Tumors That Are Likely to Express CSP
Funding Source:	ZielBio, Inc
Role:	PI
ID:	2021-1162

Date:	2022 - 2029
Title:	A Phase I, Open Label, Multicenter Study to Evaluate the Safety and Efficacy of PUR001 Administered Intravenously in Adult Patients with Advanced Solid Tumors
Funding Source:	Purinomia Biotech, Inc
Role:	PI
ID:	2021-1097

Date:	2022 - 2029
Title:	A Phase 1/2, Open-label, Multicenter Study to Investigate the Safety, Pharmacokinetics and Efficacy of CYC140, an Oral PLK1 Inhibitor, in Subjects with Advanced Solid Tumors and Lymphoma
Funding Source:	Cyclacel Pharmaceuticals, Inc
Role:	PI
ID:	2021-1196

Date:	2022 - 2027
Title:	A Phase 1, First-in-Human Study of NTX-1088, a Monoclonal Antibody Targeting the Poliovirus Receptor (PVR), as Monotherapy and Combined with Pembrolizumab, in Patients with Advanced Solid Malignancies
Funding Source:	Nectin Therapeutics, Ltd
Role:	PI
ID:	2022-0303

Date:	2022 - 2029
Title:	A Phase 1 Study of Oral LOXO-260 in Patients with RET Fusion-Positive Solid Tumors, Medullary Thyroid Cancer, and Other Tumors With RET Activation Refractory to Selective RET Inhibitors
Funding Source:	Loxo Oncology, Inc. and Eli Lilly, Co
Role:	PI
ID:	2022-0090

Date:	2021 - 2028
Title:	A Phase 1 Open-Label, Dose-Escalation and Cohort Expansion Study of LUNA18 Monotherapy and Combination Therapy in Patients with Locally Advanced or Metastatic Solid Tumors
Funding Source:	Chugai Pharmaceutical Co., Ltd
Role:	PI
ID:	2021-0607

Date:	2021 - 2025
Title:	Open-label Rollover Study to Evaluate Long-Term Safety in Subjects with Metastatic Solid Tumors that are Benefiting from Continuation of Therapy with Sacituzumab Govitecan
Funding Source:	Gilead Sciences, Inc
Role:	PI
ID:	2021-0528

Date:	2021 - 2024
Title:	A Phase 2, Multi-Center, Open-Label Study of Cinrebafusp Alfa in Combination with Ramucirumab and Paclitaxel in Patients with HER2-Positive Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma
Funding Source:	Pieris Pharmaceuticals, Inc
Role:	PI
ID:	2021-0125

Date:	2021 - 2028
Title:	A Phase Ib/II, Multicenter, Open-Label Study of TT-00420 Tablet, as Monotherapy or in Combination Regimens, in Patients with Advanced Solid Tumors
Funding Source:	Transthera Biosciences, Co., Ltd
Role:	PI
ID:	2020-1164

Date:	2021 - 2023
Title:	A Phase 2 Study of Intratumoral Injection of LTX-315 in Combination with Pembrolizumab in Patients with Percutaneously Accessible Advanced Solid Tumors
Funding Source:	Lytix Biopharma AS
Role:	PI
ID:	2021-0044

Date:	2021 - 2028
Title:	A Phase 1, Open-Label, Dose-Escalation Study to Determine an Appropriate Starting Dose of Sacituzumab Govitecan in Subjects with Advanced or Metastatic Solid Tumor and Moderate Liver Impairment
Funding Source:	Gilead Sciences
Role:	PI
ID:	2021-0342

Date:	2021 - 2025
Title:	A Phase 1/2, Open-Label, Multicenter Study to Investigate the Safety, Pharmacokinetics, and Efficacy of Fadraciclib (CYC065), an Oral CDK2/9 Inhibitor, in Subjects with Advanced Solid Tumors and Lymphoma
Funding Source:	Cyclacel Pharmaceuticals, Inc
Role:	PI
ID:	2021-0382

Date:	2021 - 2023
Title:	A Multicenter, Open-label, Phase 1a Study of HC-5404-FU in Subjects with Selected, Advanced Solid Tumors
Funding Source:	HiberCell, Inc
Role:	PI
ID:	2021-0113

Date:	2021 - 2028
Title:	A Phase 1/2A Trial of ENB-003 in Combination with Pembrolizumab in Subjects with Advanced Solid Tumors
Funding Source:	ENB Therapeutics, Inc
Role:	PI
ID:	2020-0725

Date:	2021 - 2024
Title:	A Phase 1/2a, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of JAB-3312 in Adult Patients with Advanced Solid Tumors
Funding Source:	Jacobio Pharmaceuticals Co., Ltd
Role:	PI
ID:	2020-1311

Date:	2021 - 2023
Title:	A Phase 1, Open-Label, Dose Escalation, and Cohort Expansion First-in-Human Study of the Safety, Tolerability, Pharmacokinetics, and Activity of FS120, an OX40/CD137 Bispecific Antibody, in Subjects with Advanced Malignancies
Funding Source:	F-Star Biotechnology Ltd
Role:	PI
ID:	2020-0191

Date:	2020 - 2025
Title:	A Phase I, Open-Label, Multicenter, Dose Escalation and Cohort Expansion Study of SPYK04 as Monotherapy in Patients with Locally Advanced or Metastatic Solid Tumors
Funding Source:	Chugai Pharmaceutical Co., Ltd
Role:	PI
ID:	2020-0432

Date:	2020 - 2022
Title:	A Phase I, First-In-Human, Multicenter, Open-Label, Study of GQ1001, a HER2 Targeted Antibody-Drug Conjugate, Administered Intravenously in Adult Patients with HER2-Positive Advanced Solid Tumors
Funding Source:	Gene Quantum Healthcare, Co., Ltd
Role:	PI
ID:	2020-0489

Date:	2020 - 2027
Title:	A Phase 1a/1b Study Exploring the Safety and Tolerability of INCB081776 in Participants with Advanced Malignancies
Funding Source:	Incyte Corporation
Role:	PI
ID:	2020-0259

Date:	2020 - 2022
Title:	A Phase 1/1b Open-Label, Dose Escalation and Expansion Study of SBT6050 in Subjects with Advanced Solid Tumors Expressing HER2
Funding Source:	Silverback Therapeutics
Role:	PI
ID:	2020-0326

Date:	2020 - 2027
Title:	A Phase 1 Study Exploring the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099280 in Participants with Select Advanced Solid Tumors
Funding Source:	Incyte Corporation
Role:	PI
ID:	2020-0082

Date:	2020 - 2027
Title:	A Phase 1 Study of SGN-B6A in Advanced Solid Tumors
Funding Source:	Seattle Genetics
Role:	PI
ID:	2020-0360

Date:	2020 - 2025
Title:	Clinical and Immunologic Activity of ALKS 4230 on Tumor Microenvironment in Solid Tumor Patients – ARTISTRY-3
Funding Source:	Alkermes, Inc
Role:	PI
ID:	2020-0370

Date:	2020 - 2022
Title:	A Phase I, Open Label, Dose Escalation Study of ACE1702 Cell lmmunotherapy in Subjects with Advanced or Metastatic HER2-expressing Solid Tumors
Funding Source:	Acepodia Biotech, Inc
Role:	PI
ID:	2019-1232

Date:	2020 - 2027
Title:	Phase I/II Study of the Selective RET Inhibitor TAS0953/HM06 in Patients with Advanced Solid Tumors with RET Gene Abnormalities
Funding Source:	Helsinn Healthcare SA
Role:	PI
ID:	2020-0815

Date:	2020 - 2027
Title:	A Multicenter Phase 1/2a, Open-Label Study of SQ3370 in Patients with Advanced Solid Tumors
Funding Source:	Shasqi, Inc
Role:	PI
ID:	2020-0185

Date:	2020 - 2027
Title:	A Phase 1/1b, Open-label Clinical Study of Intratumoral/Intralesional Administration of V938 in Combination with Pembrolizumab (MK-3475) in Participants with Advanced/Metastatic or Recurrent Malignancies
Funding Source:	Merck Sharp & Dohme Corp
Role:	PI
ID:	2019-0413

Date:	2019 - 2025
Title:	Phase I/II, Two-Part, Multicenter First-in-Human Study of Ifinatamab Deruxtecan (DS-7300a, I-DXd) in Subjects with Advanced Solid Malignant Tumors (IDeate-PanTumor01)
Funding Source:	Daiichi Sankyo, Inc
Role:	Principal Investigator-MDACC
ID:	2019-0987

Date:	2019 - 2022
Title:	A Phase I Multicenter Global First in Human Study of the CD73 Inhibitor LY3475070 as Monotherapy or in Combination with Pembrolizumab in Patients with Advanced Solid Malignancies
Funding Source:	Eli Lilly
Role:	PI
ID:	2019-0909

Date:	2019 - 2024
Title:	A Phase 1/2 Study of ALKS 4230 Administered Subcutaneously as Monotherapy and in Combination with Pembrolizumab in Subjects with Advanced Solid Tumors-ARTISTRY-2 (001)
Funding Source:	Alkermes, Inc
Role:	PI
ID:	2019-0657

Date:	2019 - 2026
Title:	A Phase 1a/1b Dose-escalation Study of Intravenously Administered SB 11285 Alone and in Combination with Atezolizumab in Patients with Advanced Solid Tumors
Funding Source:	F-star Therapeutics, Inc
Role:	PI
ID:	2019-0562

Date:	2019 - 2026
Title:	A Phase 1, Open-label, Multicenter Study of SYNB1891 Administered by Intratumoral Injection to Patients with Advanced/Metastatic Solid Tumors or Lymphoma, Alone and in Combination with Atezolizumab
Funding Source:	Synlogic
Role:	PI
ID:	2019-0576

Date:	2019 - 2021
Title:	A Phase 1 First-in-Human Dose Escalation and Expansion Study for the Evaluation of Safety, Pharmacokinetics, Pharmacodynamics and Anti-Tumor Activity of SAR441000 Administered Intratumorally as Monotherapy and in Combination with Cemiplimab in Patients with advanced solid tumors
Funding Source:	Sanofi
Role:	PI
ID:	2018-1101

Date:	2019 - 2023
Title:	A Phase 1, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of JAB-3312 in Adult Patients with Advanced Solid Tumors
Funding Source:	Jacobio Pharmaceuticals, Co, Ltd
Role:	PI
ID:	2019-0495

Date:	2019 - 2023
Title:	A Phase I Dose Escalation with Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMV564 in Subjects with Advanced Solid Tumors
Funding Source:	Amphivena Therapeutics, Inc
Role:	PI
ID:	2019-0552

Date:	2019 - 2026
Title:	A Phase I Study of SGN-CD47M in Patients with Advanced Solid Tumors
Funding Source:	Seattle Genetics
Role:	PI
ID:	2019-0001

Date:	2019 - 2023
Title:	Phase 1/2 Dose-Escalation and Expansion Study of FLX475 Alone and in Combination with Pembrolizumab in Advanced Cancer
Funding Source:	RAPT Therapeutics
Role:	PI
ID:	2019-0139

Date:	2019 - 2026
Title:	A Phase 1, Multi-Center, Dose Escalation, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of JAB-3068 in Adult Patients with Advanced Solid Tumors
Funding Source:	Jacobio Pharmaceuticals, Co., Ltd
Role:	PI
ID:	2018-1004

Date:	2019 - 2022
Title:	An Open Label, Phase Ia/Ib Dose Finding Study with BI 894999 Orally Administered Once a Day in Patients with Advanced Malignancies with Repeated Administration in Patients with Clinical Benefit
Funding Source:	Boehringer Ingelheim
Role:	PI
ID:	2018-0682

Date:	2018 - 2025
Title:	A Phase I, First-In-Human, Multicenter, Open-Label Study of TT-00420, Administered Orally in Adult Patients with Advanced Solid Tumors and Triple Negative Breast Cancers
Funding Source:	TransThera Biosciences
Role:	PI
ID:	2018-0707

Date:	2018 - 2023
Title:	A Phase 1b, Open-Label, Dose Escalation Study of PRS-343 in Combination with Atezolizumab in Patients with Specific HER2-Positive Advanced or Metastatic Solid Tumors
Funding Source:	Pieris Pharmaceuticals, Inc
Role:	PI
ID:	2018-0667

Date:	2018 - 2019
Title:	2018-0641 A Phase 1 Dose Escalation and Cohort Expansion Study of ERY974, an Anti-Glypican 3 (GPC3)/CD3 Bispecific Antibody, in Patients with Advanced Solid Tumors
Funding Source:	Chugai Pharmaceutical Co., Ltd
Role:	PI
ID:	2018-0641

Date:	2018 - 2023
Title:	A Phase 1/2 First-in-Human Study of BMS-986249 Alone and in Combination with Nivolumab in Advanced Solid Tumors
Funding Source:	Bristol-Myers Squib (BMS)
Role:	PI
ID:	2018-0483 (CA030-001)

Date:	2018 - 2025
Title:	Phase I Dose-Finding, Safety Study of Oral AMXT 1501 Dicaprate and Difluoromethylornithine (DFMO) in Patients with Advanced Solid Tumors
Funding Source:	Aminex Therapeutics, Inc
Role:	PI
ID:	2018-0524

Date:	2018 - 2023
Title:	A Phase 1/2a Study of BMS-986253 in Combination with Nivolumab in Advanced Cancers
Funding Source:	Bristol-Myers Squibb (BMS)
Role:	PI
ID:	2018-0482

Date:	2018 - 2022
Title:	A Phase I Study Exploring the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB086550 in Participants with Advanced Solid Tumors
Funding Source:	Incyte Corporation
Role:	PI
ID:	2018-0765

Date:	2018 - 2019
Title:	A Phase I Open-Label Pharmacokinetics and Safety Study of Talazoparib (MDV3800) in Patients with Advanced Solid Tumors and Normal or Varying Degrees of Renal Impairment
Funding Source:	Pfizer
Role:	PI
ID:	2016-0797

Date:	2018 - 2022
Title:	A Phase I, Open-Label Study of GSK1795091 Administered in Combination with Immunotherapies in Participants with Advanced Solid Tumors
Funding Source:	GlaxoSmithKline
Role:	PI
ID:	2017-0968

Date:	2018 - 2023
Title:	A Phase 1/2, Open-Label, First-in-Human Study to Evaluate the Safety and Anti-Tumor Activity of FS118, a LAG-3/PD-L1 Bispecific Antibody, in Patients with Advanced Malignancies
Funding Source:	F-Star Biotechnology Ltd
Role:	PI
ID:	2018-0060

Date:	2018 - 2022
Title:	First-in-Human, Open-Label, Dose-Escalation trial with expansion cohorts to evaluate safety of Axl-Specific Antibody-Drug Conjugate (HuMax-AXL-ADC) in patients with solid tumors
Funding Source:	Genmab
Role:	PI
ID:	2017-0851

Date:	2018 - 2023
Title:	A Phase I Study of BMS-986299 as Monotherapy and in Combination with Nivolumab and Ipilimumab in Participants with Advanced Solid Cancers
Funding Source:	Bristol-Myers Squibb Co
Role:	PI
ID:	2017-1041

Date:	2018 - 2023
Title:	A Phase I/II, Open-label, Multicenter Study to Investigate the Safety, Pharmacokinetics, and Efficacy of TAS0728, an Oral Covalent Binding Inhibitor of HER2, in Subjects with Advanced Solid Tumors with HER2 or Her3 Abnormalities
Funding Source:	Taiho Pharmaceutical Co. Ltd
Role:	PI
ID:	2017-0994

Date:	2018 - 2026
Title:	A Phase Ib Investigation of Pembrolizumab in Combination with Intratumoral Injection of Clostridium novyi-NT in Patients with Treatment-Refractory Solid Tumors
Funding Source:	BVD (Merck Sharp & Dohme)
Role:	PI
ID:	2017-0719

Date:	2018 - 2025
Title:	A Phase I Trial of MK-4280 as Monotherapy and in Combination with Pembrolizumab with or without Chemotherapy in Subjects with Advanced Solid Tumors
Funding Source:	Merck
Role:	PI
ID:	2017-0624

Date:	2018 - 2023
Title:	An Open-Label, Randomized-Sequence, Multicenter, Single-Crossover Study to Assess the Relative Bioavailability and Bioequivalence of Niraparib Tablet Formulation Compared to Niraparib Capsule Formulation in Patients with Advanced Solid Tumors
Funding Source:	Tesaro, Inc
Role:	PI
ID:	2017-0682

Date:	2018 - 2021
Title:	An Open-Label, Non-Randomized, Multicenter Study to Determine the Pharmacokinetics and Safety of Niraparib Following a Single Oral Dose in Patients with Advanced Solid Tumors and Either Normal Hepatic Function or Moderate Hepatic Impairment
Funding Source:	Tesaro, Inc
Role:	PI
ID:	2017-0790

Date:	2017 - 2021
Title:	Modular Phase 2 Study to Link Combination Immune-therapy to Patients with Advanced Solid and Hematologic Malignancies; Module 9 PDR001 Plus LAG525 for Patients with Advanced Solid and Hematologic Malignancies
Funding Source:	Novartis Pharmaceuticals
Role:	PI
ID:	2017-0863

Date:	2017 - 2024
Title:	A Phase I, Open-Label, Dose Escalation Study of PRS-343 in Patients with HER2-Positive Advanced or Metastatic Solid Tumors
Funding Source:	Pieris Pharmaceuticals, Inc
Role:	PI
ID:	2017-0297

Date:	2017 - 2026
Title:	Phase I Study of the Pan-ERBB Inhibitor Neratinib Given in Combination with Everolimus, Palbociclib or Trametinib in Advanced Cancer Subjects with EGFR Mutation/Amplification, HER2 Mutation/Amplification or HER3/4 Mutation
Funding Source:	Puma Biotechnology, Inc. and MDACC
Role:	PI
ID:	2016-0430

Date:	2017 - 2024
Title:	A Phase 1/2 Study of Oral LOXO-292 in Patients with Advanced Solid Tumors, Including RET-Fusion Positive Solid Tumors, Medullary Thyroid Cancer, and Other Tumors with RET Activation (LIBRETTO-001)
Funding Source:	Loxo Oncology, Inc/Eli Lilly
Role:	PI
ID:	2017-0202

Date:	2017 - 2022
Title:	A Phase I Open-Label Pharmacokinetics and Safety Study of Talazoparib (MDV3800) in Patients with Advanced Solid Tumors and Normal or Varying Degrees of Hepatic Impairment
Funding Source:	Medivation
Role:	PI
ID:	2016-0798

Date:	2017 - 2020
Title:	A Phase I Open-Label Pharmacokinetics and Safety Study of Talazoparib (MDV3800) in Patients with Advanced Solid Tumors and Normal or Varying Degrees of Renal Impairment
Funding Source:	Medivation
Role:	PI
ID:	2016-0797

Date:	2017 - 2021
Title:	A Single-Arm, Open-Label, Multicenter, Extended Treatment, Safety Study in Patients Treated with Talazoparib
Funding Source:	Medivation, Inc
Role:	PI
ID:	2016-0886

Date:	2017 - 2024
Title:	A Phase 1/2 Study of the Highly Selective RET Inhibitor, BLU-667, in Patients with Thyroid Cancer, Non-Small Cell Lung Cancer (NSCLC) and Other Advanced Solid Tumors 2016-1007
Funding Source:	Roche/Blueprint
Role:	PI
ID:	2016-1007

Date:	2017 - 2020
Title:	A Phase I Multicenter, Open-Label, Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Antitumor Activity of MEDI0562 in Combination with Immune Therapeutic Agents in Adult Subjects with Advanced Solid Tumors
Funding Source:	MedImmune, LLC
Role:	PI
ID:	2016-0214

Date:	2017 - Present
Title:	Phase I Study of Veliparib (ABT-888), an Oral PARP Inhibitor, and M6620 (VX-970), an ATR Inhibitor in Combination with Cisplatin in Patients with Refractory Solid Tumors
Funding Source:	NIH/NCI
Role:	Principal Investigator-MDACC
ID:	NCI9771

Date:	2016 - 2023
Title:	A phase 1, open-label, dose-escalation study of SEA-CD40 in adult patients with advanced malignancies
Funding Source:	Seattle Genetics
Role:	Co-PI
ID:	2016-0356

Date:	2016 - 2020
Title:	A Phase I/Ib Open-Label, Multi-Center, Dose Escalation Study of GWN323 (Anti-GITR) as a single agent and in combination with PDR001 (anti-PD-1) in patients with advanced solid tumors and lymphomas
Funding Source:	Novartis
Role:	PI
ID:	2016-0277

Date:	2016 - 2018
Title:	Phase 1/2a Dose-Escalation Study of CRLX301 in Patients with Advanced Solid Tumor Malignancies
Funding Source:	Cerulean Pharma Inc
Role:	PI
ID:	2015-1116

Date:	2016 - 2020
Title:	A Phase 1a/1b Study of FPA008 in Combination with Nivolumab in Patients with Selected Advanced Cancers
Funding Source:	Five Prime Therapeutics
Role:	PI
ID:	2015-0732

Date:	2016 - 2023
Title:	A Clinical Trial of Pembrolizumab (MK-3475) Evaluating Predictive Biomarkers in Subjects with Advanced Solid Tumors (KEYNOTE 158)
Funding Source:	Merck Sharp & Dohme Corp
Role:	PI
ID:	2015-0871

Date:	2015 - 2018
Title:	Evaluation of an Alternative Schedule for CRLX101 Alone and in Combination with Bevacizumab in Subjects with Advanced Solid Tumor Malignancies
Funding Source:	Cerulean Pharma, Inc
Role:	PI
ID:	2015-0838

Date:	2015
Title:	A Phase I Open-Label, Multicenter, Dose-Escalation Study of PRN1371, A FGFR1-4 Kinase Inhibitor, in Adult Patients with Advanced Solid Tumors, followed by an Expansion Cohort in Patients with FGFR1, 2, 3, or 4 Genetic Alterations, 2015-0480, 2015-2017
Funding Source:	Principia Biopharma, Inc
Role:	PI
ID:	2015-0480

Date:	2015 - 2020
Title:	A Phase 1 Open-Label, Multicenter, Dose-Escalation Study of PRN1371, a FGFR1-4 Kinase Inhibitor, in Adult Patients with Advanced Solid Tumors, followed by an Expansion Cohort in Patients with FGFR 1, 2, 3 or 4 Genetic Alterations
Funding Source:	PDL BioPharma Inc
Role:	PI
ID:	2015-0480

Date:	2015 - 2022
Title:	Phase I, Open Label, Dose Escalation, Safety and Tolerability Study of INCB054329 in Subjects with Advance Malignancies
Funding Source:	Incyte Corporation
Role:	PI
ID:	2015-0054

Date:	2015 - 2020
Title:	Phase I Open Label, Multi-Center Study to Assess the Safety, tolerability and Pharmacokinetics of Orally Administered CUDC-907, an HDAC and PI3K Inhibitor in subjects with Advanced/Relapsed Solid Tumors
Funding Source:	Curis
Role:	PI
ID:	2015-0033

Date:	2015 - 2022
Title:	A Phase 1 Study Evaluating the Safety and Pharmacokinetics of ABBV-075 in Subjects with Advanced Cancer
Funding Source:	Abbvie
Role:	PI
ID:	2014-0959

Date:	2015 - 2018
Title:	A Phase 1, Open-Label, Dose-Escalation, Dose-Finding Study Evaluating the Safety and Pharmacokinetics of SM04755 in Subjects with Advanced Colorectal, Gastric, Hepatic, or Pancreatic Cancer
Funding Source:	Samumed, LLC
Role:	PI

Date:	2015 - 2021
Title:	A Phase I, Open Label, Dose Escalation Study of Immunoconjugate L-DOS47 in Combination with Standard Doublet Therapy of Pemetrexed/Carboplatin in Patients with Stage IV (TNM M1a and M1b) Recurrent or Metastatic Non-Squamous Non-Small Cell Lung Cancer
Funding Source:	Helix BioPharma Corp
Role:	PI
ID:	2014-0809

Date:	2014 - 2021
Title:	A Phase 1 Study of KBP-5209 in Patients with Advanced Solid Tumors
Funding Source:	XuanZhu Pharma Co., Ltd
Role:	PI
ID:	2014-0891

Date:	2014 - Present
Title:	Phase II Study of the PARP Inhibitor Talazoparib in Advanced Cancer Patients with Somatic Alterations in BRCA1/2, Mutations/Deletions in Other BRCA Pathway Genes and Germline Mutation in BRCA1/2 (not breast or ovarian cancer)
Funding Source:	Pfizer Inc
Role:	PI
ID:	2013-0961

Date:	2014 - 2018
Title:	Modular Phase II Study to Link Targeted Therapy to Patients with Pathway Activated Tumors: Module 6-BGJ398 for Patients with Tumors with FGFR Genetic Alterations
Funding Source:	Novartis
Role:	PI
ID:	2014-0569

Date:	2014 - 2018
Title:	Modular Phase II Study To Link Targeted Therapy To Patients with Pathway Activated Tumors: Module 3 - MEK162 for Patients with RAS/RAF/MEK Activated Tumors
Funding Source:	Novartis
Role:	PI
ID:	2013-0864

Date:	2014 - 2022
Title:	Phase IB Study of MK-3475 in Subjects with Select Advanced Solid Tumors
Funding Source:	Merck Sharp & Dohme Corp
Role:	PI
ID:	2013-1008

Date:	2014 - 2018
Title:	Modular Phase II Study to Link Targeted Therapy to Patients with Pathway Activated Tumors: Module 5 - LDE225 for Patients with PTCH1 and SMO Mutated Tumors
Funding Source:	Novartis
Role:	PI
ID:	2013-1009

Date:	2014 - 2021
Title:	An Open-Label, Phase 2 Study of Neratinib in Patients with Solid Tumors with Somatic Human Epidermal Growth Factor Receptor (EGFR, HER2, HER3) Mutations or EGFR Gene Amplification
Funding Source:	Puma Biotechnology, Inc
Role:	PI
ID:	2013-0904

Date:	2013 - 2020
Title:	A Phase I/II Open-Label, Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of GSK525762 in Subjects with NUT Midline Carcinoma (NMC) and Other Cancers
Funding Source:	GlaxoSmithKline
Role:	PI
ID:	2013-0633

Date:	2013 - 2017
Title:	Modular Phase II Study to Link Targeted Therapy to Patients with Pathway Activated Tumors: Module 2 - Dovitinib for Patients with Tumor Pathway Activations Inhibited by Dovitinib Including Tumors with Mutations or Translocations of FGFR, PDGFR, VEGF, cKIT
Funding Source:	Novartis
Role:	PI
ID:	2013-0865

Date:	2013 - 2018
Title:	Modular Phase II Study to Link Targeted Therapy to Patients with Pathway Activated Tumors: Module I - BKM120 for Patients with PI3K-Activated Tumors
Funding Source:	Novartis
Role:	PI
ID:	2013-0682

Date:	2011 - 2025
Title:	Phase I Parallel Protocol of MK-8669 (Ridaforolimus) + MK-2206 and MK-8669 (Ridaforolimus) + MK-0752 Doublets (MKMK) in Patients with Advanced Cancer
Funding Source:	Merck Sharp & Dohme Corp
Role:	PI
ID:	2010-0857

Date:	2010 - 2012
Title:	A Phase 1b, Open-Label, Pharmacokinetic Drug Interaction Study of the Hedgehog Pathway Inhibitor GDC-0449 in Combination with Rosiglitazone or Combined Oral Contraceptive in Patients with Locally Advanced or Metastatic Solid Tumors that are Refractor
Funding Source:	Genentech
Role:	PI

Selected Publications

Peer-Reviewed Articles

Piha-Paul SA, Tseng C, Thompson E, Stafford RJ, Le H, Kang L, Fu S, Tsimberidou A, Blumenschein G Jr, Ahnert JR, Slopis JM, Hong D, Niang A, Meric-Bernstam F, Ng CS, Westin S, Sood AK. Phase I Study of Bevacizumab and Temsirolimus Combination Therapy in Advanced Malignancies: Safety, Efficacy, and Ovarian Cancer Expansion. Oncologist, 2025. e-Pub 2025. PMID: 41389341.
Walton SA, Kim JJ, Paoloni F, Liew JW, Haradon D, Haradon J, Miller KW, Paik PK, Chaft JE, Kris MG, Hsu R, Piha-Paul SA, Rotow JK, Janne PA, Barbie DA, Sholl LM, DuBois SG, Hanna GJ, Shapiro GI, French CA, Luo J. Presenting Features and Causes of Diagnostic Delays: A Report From the NUT Carcinoma Registry. JCO Precis Oncol 9:e2500526, 2025. e-Pub 2025. PMID: 41348986.
Piha-Paul SA, Tseng C, Tran HT, Fu S, Dumbrava EE, Yap TA, Naing A, Lim J, Murphy MB, Ramirez DL, Soliman PT, Sood AK, Meric-Bernstam F. Phase I trial of neratinib plus palbociclib in advanced cancers with HER family alterations. ESMO Open 10(12):105895, 2025. e-Pub 2025. PMID: 41223631.
Rohrberg KS, Lopez JS, Milhem MM, Blank CU, Reijers I, Thistlethwaite F, Plummer R, Piha-Paul SA, Janne PA, Shum E, Shaw HM, Debruyne PR, Lao C, Baurain JF, Choe JH, Gort E, Zhao Y, Jerusalem G, Schoffski P, Chen AW, Cohen EA, Mankowski WC, Roshkovan L, Katz SI, Kontos D, Brady LK, Qutaish M, Castro PG, Pencheva N, Bajaj G, Fu Y, Windfeld K, Reiter P, Jure-Kunkel M, Higgs BW, Amiri KI, Ahmadi T, Forssmann U, Ramalingam SS, Vergote I. Phase I/II Study of AXL-Specific Antibody-Drug Conjugate Enapotamab Vedotin in Patients with Advanced Solid Tumors. Cancer Res Commun, 2025. e-Pub 2025. PMID: 41166388.
Piha-Paul SA, Call JA, Spira AI, Bartolome J, de Miguel M, Chen X, Donatelli SS, Lakhani NJ. Less Frequent Intravenous Dosing of Nemvaleukin Alfa in Patients with Advanced Solid Tumors: The Phase 1/2 ARTISTRY-3 trial. Oncologist 30(10):oyaf301, 2025. e-Pub 2025. PMID: 40990800.
Nelson BE, Janku F, Fu S, Dumbrava EE, Hong DS, Karp DD, Naing A, Rodon J, Tsimberidou AM, Murthy R, Sheth RA, Amaria RN, Conley AP, Damodaran S, Raghav KPS, Carapanceanu N, Singh MP, Carapanceanu V, Pezeshki A, Leontovich AA, Kreider BL, Tung D, Varterasian M, Khazaie K, Piha-Paul SA. Phase Ib Study of Pembrolizumab in Combination with Intratumoral Injection of Clostridium novyi-NT in Patients with Advanced Solid Tumors. Clin Cancer Res 31(18):3864–3875, 2025. e-Pub 2025. PMID: 40643985.
Piha-Paul SA, Tolcher AW, Vandross AL, Spira AI, Burns MR. Phase I dose-escalation trial of AMXT 1501 dicaprate plus difluoromethylornithine: a dual-agent approach targeting immunosuppressive polyamine metabolism. ESMO Open 10(9):105576, 2025. e-Pub 2025. PMID: 40913836.
Braganca Xavier C, Andersen CR, Lim J, Slade JH, Bean SA, Kang L, Le H, Tsimberidou AM, Naing A, Hong DS, Dumbrava EE, Rodon Ahnert J, Pohlmann PR, Piha-Paul SA, Champiat S, Yap TA, Tang TY, Meric-Bernstam F, Fu S. Modulating Treatment Outcomes of Patients with Solid Tumors in Immunotherapy Trials: A Drug Interaction Analysis from a Phase 1 Unit. Cancer Res Commun. e-Pub 2025. PMID: 40862547.
Kim JJ, Walton SA, Mahadevan NR, Haradon J, Paoloni F, Paik PK, Chaft JE, Hsu R, Piha-Paul SA, Janne PA, Barbie DA, Sholl LM, Dubois SG, Hanna GJ, Shapiro GI, French CA, Luo J. Molecular characterization of NUT carcinoma: a report from the NUT carcinoma registry. Clin Cancer Res, 2025. e-Pub 2025. PMID: 40704901.
Lauer, UM, Awada, A, Postel-Vinay, S, Shapiro, GI, Thiéblemont, C, Piha-Paul, SA, Paik, PK, Shepard, D, Docampo, LI, Galot, R, Rottey, S, Sadrolhefazi, B, Marzin, K, Musa, H, Schöffski, P. Final results from the phase Ia/Ib study of the novel bromodomain and extra-terminal domain inhibitor, BI 894999, in patients with advanced solid tumors or diffuse large B-cell lymphoma. ESMO Open 10(5), 2025. e-Pub 2025. PMID: 40203516.
Piha-Paul, SA, Tseng, C, Tran, HT, Naing, A, Dumbrava, EE, Karp, DD, Rodon Ahnert, J, Yap, TA, Raghav, KS, Damodaran, S, Le, X, Soliman, PT, Lim, J, Meric-Bernstam, F. Phase I trial of the combination of the pan-ErbB inhibitor neratinib and mTOR inhibitor everolimus in advanced cancer patients with ErbB family gene alterations. ESMO Open 10(2), 2025. e-Pub 2025. PMID: 39908697.
Ahmed, J, Janku, F, Karp, DD, Piha-Paul, SA, Tsimberidou, AM, Yap, TA, Stephen, B, Yang, Y, Gurses, S, Liu, Q, Song, J, Meric-Bernstam, F, Naing, A. A phase 2 basket study of talabostat, a small-molecule inhibitor of dipeptidyl peptidases, administered in combination with pembrolizumab in patients with advanced solid cancers. Cancer 131(3), 2025. e-Pub 2025. PMID: 39853679.
Alhalabi, O, Gouda, MA, Milton, D, Momin, HA, Yilmaz, B, Stephen, B, Ejezie, CL, Moyers, JT, Gurses, S, How, JA, Fu, S, Rodon Ahnert, J, Hong, DS, Piha-Paul, SA, Subbiah, V, Elena Dumbrava, E, Karp, DD, Janku, F, Meric-Bernstam, F, Tannir, NM, Naing, A. A Phase IB Trial of Selinexor in Combination with Immune Checkpoint Blockade in Patients with Advanced Renal Cell Carcinoma. Cancer medicine 14(4), 2025. e-Pub 2025. PMID: 39945382.
Gouda MA, Gonugunta A, Dumbrava EE, Yap TA, Rodon J, Piha-Paul SA, Pohlmann PR, Damodaran S, Murthy R, Valero V, Mouabbi J, Tripathy D, Sahin AA, Chen H, Meric-Bernstam F. Human Epidermal Growth Factor Receptor 2 Loss Following Treatment with Trastuzumab Deruxtecan in Patients with Metastatic Breast Cancer. Clin Cancer Res, 2025. e-Pub 2025. PMID: 39841861.
Nelson BE, O'Brien S, Sheth RA, Hong DS, Naing A, Zhang X, Xu A, Hamuro L, Suryawanshi R, McKinley D, Novosiadly RD, Piha-Paul SA. Phase I study of BMS-986299, an NLRP3 agonist, as monotherapy and in combination with nivolumab and ipilimumab in patients with advanced solid tumors. J Immunother Cancer 13(1), 2025. e-Pub 2025. PMID: 39824531.
Zhou C, Wang B, Teng C, Yang H, Piha-Paul SA, Richardson G, Malalasekera A, Sun Y, Wang W, Liu J, Shi Y, Zhan X, Lemech C. A phase Ia study of a novel anti-HER2 antibody-drug conjugate GQ1001 in patients with previously treated HER2 positive advanced solid tumors. J Transl Med 23(1):37, 2025. e-Pub 2025. PMID: 39789619.
Ahmed J, Stephen B, Khawaja MR, Yang Y, Salih I, Barrientos-Toro E, Raso MG, Karp DD, Piha-Paul SA, Sood AK, Ng CS, Johnson A, Soliman PT, Meric-Bernstam F, Lu KH, Naing A. A phase I study of temsirolimus in combination with metformin in patients with advanced or recurrent endometrial cancer. Gynecol Oncol 193:73-80, 2025. e-Pub 2025. PMID: 39787747.
Nardo, M, Gouda, MA, Reilley, MJ, Biter, A, Lim, J, Bean, S, Nguyen, LM, Bhosale, PR, Ager, CR, Couillault, CA, Piha-Paul, SA, Fu, S, Tsimberidou, AM, Yap, TA, Naing, A, Rodon Ahnert, J, Subbiah, V, Karp, DD, Curran, M, Hong, DS. Lefitolimod in Combination with Ipilimumab in Patients with Advanced Solid Tumors. Journal of Immunotherapy and Precision Oncology 8(2):89-98, 2025. e-Pub 2025. PMID: 39959251.
Goldman JW, Bueno AM, Dooms C, Jhaveri K, de Miguel M, Piha-Paul SA, Unni N, Zick A, Mahipal A, Suga JM, Naltet C, Antonanzas M, Crown J, Bebchuk J, Eli LD, Lowenthal BH, Mahalingam D. Neratinib Efficacy in Patients with EGFR Exon 18-Mutant Non-Small-Cell Lung Cancer: Findings from the SUMMIT Basket Trial. Clin Lung Cancer, 2024. e-Pub 2024. PMID: 39828466.
Gouda MA, Stephen B, Tian Y, Alshawa A, Onwugaje DOC, Albittar A, Yang Y, Zarifa A, Yilmaz B, Gurses S, Sprenger A, Derbala MH, Brink A, How JA, Moyers J, Piha-Paul SA, Hong DS, Meric-Bernstam F, Patel SP, Oliva IG. A Phase Ib Study of Selinexor in Combination with Pembrolizumab in Patients with Metastatic Melanoma. J Immunother Precis Oncol 7(4):247-254, 2024. e-Pub 2024. PMID: 39524469.
Piha-Paul SA, Olwill SA, Tolcher A, Pohlmann P, Liu SV, Wurzenberger C, Hasenkamp L, Hansbauer E, Shroff R, Hurvitz S, Krishnamurthy A, Patnaik A, Hahn N, Kumar R, Duerr M, Zettl M, Aviano K, Matis L, Bruns I, Ku G. A First-in-human study of cinrebafusp alfa, a HER2/4-1BB bispecific molecule, in patients with HER2-positive advanced solid malignancies. Clin Cancer Res, 2024. PMID: 39235868.
Abou-Alfa, GK, Meyer, T, Do, RK, Piha-Paul, SA, Light, JS, Sherrin, S, Yaqubie, A, O'Neill, AC, Harding, JJ, Al-Rajabi, R, Denlinger, CS, Cano, P, Cornelius, AS, O'Reilly, EM, DiPrimeo, D, Eli, LD, Gordan, JD, Solit, DB. Neratinib Alone or in Combination with Immune Checkpoint Inhibitors with or without Mammalian Target of Rapamycin Inhibitors in Patients with Fibrolamellar Carcinoma. Liver Cancer 14(1):58-67, 2024. e-Pub 2024. PMID: 40144471.
Piha-Paul SA, Tseng C, Leung CH, Yuan Y, Karp DD, Subbiah V, Hong D, Fu S, Naing A, Rodon J, Javle M, Ajani JA, Raghav KP, Somaiah N, Mills GB, Tsimberidou AM, Zheng X, Chen K, Meric-Bernstam F. Phase II study of talazoparib in advanced cancers with BRCA1/2, DNA repair, and PTEN alterations. NPJ Precis Oncol 8(1):166, 2024. e-Pub 2024. PMID: 39085400.
Gouda MA, Shunyakova J, Naing A, Dumbrava E, Hong DS, Yuan Y, Yang P, Myers A, Liang Y, Peng J, Karp D, Tsimberidou AM, Rodon J, Yap TA, Piha-Paul SA, Meric-Bernstam F, Fu S. A phase I study of TAK-659 and paclitaxel in patients with taxane-refractory advanced solid tumors. ESMO Open 9(6):103486, 2024. e-Pub 2024. PMID: 38914452.
Luo J, Sanchez M, Lee E, Hertzler H, Luong N, Mazzola E, Finstein B, Tamen R, Brisbane G, Nguyen T, Paik PK, Chaft JE, Cheng ML, Khalil H, Piha-Paul SA, Sholl LM, Nishino M, Jänne PA, DuBois SG, Hanna GJ, Shapiro GI, French CA. Initial chemotherapy for locally advanced and metastatic NUT carcinoma. J Thorac Oncol 19(5):829-838, 2024. e-Pub 2024. PMID: 38154515.
Piha-Paul SA, Xu B, Dumbrava EE, Fu S, Karp DD, Meric-Bernstam F, Hong DS, Rodon JA, Tsimberidou AM, Raghav K, Ajani JA, Conley AP, Mott F, Fan Y, Fan J, Peng P, Wang H, Ni S, Sun C, Qiang X, Levin WJ, Ngo B, Ru QC, Wu F, Javle MM. First-In-Human Phase I Study of Tinengotinib (TT-00420), a Multiple Kinase Inhibitor, as a Single Agent in Patients With Advanced Solid Tumors. Oncologist 29(4):e514-e525, 2024. e-Pub 2024. PMID: 38297981.
Falchook G, Patnaik A, Richardson DL, Harvey RD, Sharma MR, Hafez N, Hamilton E, Piha-Paul SA, Barve M, Wise-Draper T, Patel MR, Dowlati A, Pascuzzo J, Tang SC, Faltermeier C, Malinowska IA, Shtessel L, Striha A, Potocka E. A Relative Bioavailability, Bioequivalence, and Food Effect Study of Niraparib Tablets in Patients with Advanced Solid Tumors. Clin Ther 46(3):228-238, 2024. e-Pub 2024. PMID: 38423866.
Nelson BE, Roszik J, Ahmed J, Barretto CMN, Nardo M, Campbell E, Johnson AM, Piha-Paul SA, Oliva ICG, Weathers SP, Cabanillas M, Javle M, Meric-Bernstam F, Subbiah V. RAF inhibitor re-challenge therapy in BRAF-aberrant pan-cancers: the RE-RAFFLE study. Mol Cancer 23(1):64, 2024. e-Pub 2024. PMID: 38532456.
Knisely A, Ahmed J, Stephen B, Piha-Paul SA, Karp D, Zarifa A, Fu S, Hong DS, Rodon Ahnert J, Yap TA, Tsimberidou AM, Alshawa A, Dumbrava EE, Yang Y, Song J, Meric-Bernstam F, Jazaeri AA, Naing A. Phase 1/2 trial of avelumab combined with utomilumab (4-1BB agonist), PF-04518600 (OX40 agonist), or radiotherapy in patients with advanced gynecologic malignancies. Cancer 130(3):400-409, 2024. e-Pub 2024. PMID: 37864520.
Subbiah V, Coleman N, Piha-Paul SA, Tsimberidou AM, Janku F, Rodon J, Pant S, Dumbrava EE, Fu S, Hong DS, Zhang S, Sun M, Jiang Y, Roszik J, Song J, Yuan Y, Meric-Bernstam F, Naing A. Phase I study of mTORC1/2 inhibitor sapanisertib in combination with metformin in patients with mTOR/AKT/PI3K pathway alterations and advanced solid malignancies. Cancer Res Commun 4(2):378-387, 2024. e-Pub 2024. PMID: 38126764.
Coleman N, Stephen B, Fu S, Karp D, Subbiah V, Ahnert JR, Piha-Paul SA, Wright J, Fessahaye SN, Ouyang F, Yilmaz B, Meric-Bernstam F, Naing A. Phase I study of sapanisertib (CB-228/TAK-228/MLN0128) in combination with ziv-aflibercept in patients with advanced solid tumors. Cancer Med 13(3):e6877, 2024. e-Pub 2024. PMID: 38400671.
Tang C, Hartley GP, Couillault C, Yuan Y, Lin H, Nicholas C, Srinivasamani A, Dai J, Dumbrava EEI, Fu S, Karp DD, Naing A, Piha-Paul SA, Rodon Ahnert J, Pant S, Subbiah V, Yap TA, Tsimberidou AM, Guerrero P, Dhebat S, Proia T, Curran MA, Hong DS. Preclinical study and parallel phase II trial evaluating antisense STAT3 oligonucleotide and checkpoint blockade for advanced pancreatic, non-small cell lung cancer and mismatch repair-deficient colorectal cancer. BMJ Oncol 3(1):e000133, 2024. e-Pub 2024. PMID: 39886125.
Nelson BE, Tsimberidou AM, Fu X, Fu S, Subbiah V, Sood AK, Rodon J, Karp DD, Blumenschein G, Kopetz S, Pant S, Piha-Paul SA. A Phase I Trial of Bevacizumab and Temsirolimus in Combination with Valproic Acid in Advanced Solid Tumors. Oncologist 28(12):1100-e1292, 2023. e-Pub 2023. PMID: 37311055.
Phadnis S, Wang X, Daw NC, Herzog CE, Subbiah IM, Zaky W, Gouda MA, Morani AC, Amini B, Harrison DJ, Piha-Paul SA, Meric-Bernstam F, Gorlick R, Schwartz CL, Subbiah V. Everolimus in combination with vandetanib in children, adolescents, and young adults: a phase I study. ESMO Open 8(6):101609, 2023. e-Pub 2023. PMID: 37879233.
Uzunparmak B, Haymaker C, Raso G, Masciari S, Wang L, Lin H, Gorur A, Kirby B, Cimo AM, Kennon A, Ding Q, Urschel G, Yuan Y, Feng G, Rizvi Y, Hussain A, Zhu C, Kim P, Abbadessa G, Subbiah V, Yap TA, Rodon J, Piha-Paul SA, Meric-Bernstam F, Dumbrava EE. HER2-low expression in patients with advanced or metastatic solid tumors. Ann Oncol 34(11):1035-1046, 2023. e-Pub 2023. PMID: 37619847.
Jhaveri K, Eli LD, Wildiers H, Hurvitz SA, Guerrero-Zotano A, Unni N, Brufsky A, Park H, Waisman J, Yang ES, Spanggaard I, Reid S, Burkard ME, Vinayak S, Prat A, Arnedos M, Bidard FC, Loi S, Crown J, Bhave M, Piha-Paul SA, Suga JM, Chia S, Saura C, JÁ G, Gambardella V, de Miguel MJ, Gal-Yam EN, Rapael A, Stemmer SM, Ma C, Hanker AB, Ye D, Goldman JW, Bose R, Peterson L, Bell JSK, Frazier A, DiPrimeo D, Wong A, Arteaga CL, Solit DB. Neratinib + fulvestrant + trastuzumab for HR-positive, HER2-negative, HER2-mutant metastatic breast cancer: outcomes and biomarker analysis from the SUMMIT trial. Ann Oncol 34(10):885-898, 2023. e-Pub 2023. PMID: 37597578.
Piha-Paul SA, Tseng C, Tran HT, Gao M, Karp DD, Subbiah V, Tsimberidou AM, Kawedia JD, Fu S, Pant S, Yap TA, Morris VK, Kee BK, Blum Murphy M, Lim J, Meric-Bernstam F. A phase I trial of the pan-ERBB inhibitor neratinib combined with the MEK inhibitor trametinib in patients with advanced cancer with EGFR mutation/amplification, HER2 mutation/amplification, HER3/4 mutation or KRAS mutation. Cancer Chemother Pharmacol 92(2):107-118, 2023. e-Pub 2023. PMID: 37314501.
Chelariu-Raicu A, Piha-Paul SA, Chavez-MacGregor M, Johnson J, Sawaya R, McAleer MF, Nguyen A, Hartnett A, Tsimberidou AM, Meric-Bernstam F, Dumbrava EE. Multidisciplinary Care of a Large Brain Metastasis in a Patient with Hormone-Receptor-Positive Breast Cancer with Ataxia-Telangiectasia Mutation. J Immunother Precis Oncol 6(3):158-161, 2023. e-Pub 2023. PMID: 37637237.
DiPeri TP, Kong K, Varadarajan K, Karp DD, Ajani JA, Pant S, Press MF, Piha-Paul SA, Dumbrava EE, Meric-Bernstam F. Discordance of HER2 Expression and/or Amplification on Repeat Testing. Mol Cancer Ther 22(8):976-984, 2023. e-Pub 2023. PMID: 37339271.
Luke JJ, Piha-Paul SA, Medina T, Verschraegen CF, Varterasian M, Brennan AM, Riese RJ, Sokolovska A, Strauss JF, Hava DL, Janku F. Phase I study of SYNB1891, an engineered E coli Nissle strain expressing STING agonist, with and without atezolizumab in advanced malignancies. Clin Cancer Res 29(13):2435-2444, 2023. e-Pub 2023. PMID: 37159185.
Luke JJ, Piha-Paul SA, Medina T, Verschraegen CF, Varterasian M, Brennan AM, Riese RJ, Sokolovska A, Strauss J, Hava DL, Janku F. Phase I Study of SYNB1891, an Engineered E. coli Nissle Strain Expressing STING Agonist, with and without Atezolizumab in Advanced Malignancies. Clin Cancer Res 29(13):2435-2444, 2023. e-Pub 2023. PMID: 37227176.
Nelson BE, Saleem S, Damodaran S, Somaiah N, Piha-Paul S, Moore JA, Yilmaz B, Ogbonna D, Karp DD, Dumbrava E, Tsimberidou AM, Hong DS, Rodon Ahnert J, Milton DR, Zheng X, Booser DJ, Ibrahim NK, Conley AP, Bhosale P, Rojas Hernandez CM, Tripathy D, Naing A, Meric-Bernstam F. Phase 1b study of combined selinexor and eribulin for the treatment of advanced solid tumors and triple-negative breast cancer. Cancer 129(14):2201-2213, 2023. e-Pub 2023. PMID: 37016732.
Carmagnani Pestana R, Moyers JT, Roszik J, Sen S, Hong DS, Naing A, Herzog CE, Fu S, Piha-Paul SA, Rodon J, Yap TA, Karp DD, Tsimberidou AM, Pant S, Zarzour MA, Ratan R, Ravi V, Benjamin RS, Lazar AJ, Wang WL, Daw N, Gill JB, Harrison DJ, Lewis VO, Roland CL, Patel SR, Livingston JA, Somaiah N, Ludwig JA, Conley AP, Hamerschlak N, Gorlick R, Meric-Bernstam F, Subbiah V. Impact of Biomarker-Matched Therapies on Outcomes in Patients with Sarcoma Enrolled in Early-Phase Clinical Trials (SAMBA 101). Clin Cancer Res 29(9):1708-1718, 2023. e-Pub 2023. PMID: 37058010.
Fu S, Yao S, Yuan Y, Previs RA, Elias AD, Carvajal RD, George TJ, Yuan Y, Yu L, Westin SN, Xing Y, Dumbrava EE, Karp DD, Piha-Paul SA, Tsimberidou AM, Ahnert JR, Takebe N, Lu K, Keyomarsi K, Meric-Bernstam F. Multicenter Phase II Trial of the WEE1 Inhibitor Adavosertib in Refractory Solid Tumors Harboring CCNE1 Amplification. J Clin Oncol 41(9):1725-1734, 2023. e-Pub 2023. PMID: 36469840.
Harding JJ, Piha-Paul SA, Shah RH, Murphy JJ, Cleary JM, Shapiro GI, Quinn DI, Braña I, Moreno V, Borad M, Loi S, Spanggaard I, Park H, Ford JM, Arnedos M, Stemmer SM, de la Fouchardiere C, Fountzilas C, Zhang J, DiPrimeo D, Savin C, Duygu Selcuklu S, Berger MF, Eli LD, Meric-Bernstam F, Jhaveri K, Solit DB, Abou-Alfa GK. Antitumour activity of neratinib in patients with HER2-mutant advanced biliary tract cancers. Nat Commun 14(1):630, 2023. e-Pub 2023. PMID: 36746967.
Son J, Lin HY, Fu S, Biter AB, Dumbrava EE, Karp DD, Naing A, Pant S, Piha-Paul SA, Rodon J, Subbiah V, Tsimberidou AM, Yap TA, Frumovitz MM, Jazaeri AA, Ramirez PT, Westin SN, Yuan Y, Meric-Bernstam F, Hong DS. Predictors of Oncologic Outcome in Patients Receiving Phase I Investigational Therapy for Recurrent or Metastatic Cervical Cancer. J Immunother Precis Oncol 6(1):10-18, 2023. e-Pub 2023. PMID: 36751659.
Nelson BE, Roszik J, Janku F, Hong DS, Kato S, Naing A, Piha-Paul S, Fu S, Tsimberidou A, Cabanillas M, Busaidy NL, Javle M, Byers LA, Heymach JV, Meric-Bernstam F, Subbiah V. BRAF v600E-mutant cancers treated with vemurafenib alone or in combination with everolimus, sorafenib, or crizotinib or with paclitaxel and carboplatin (VEM-PLUS) study. NPJ Precis Oncol 7(1):19, 2023. e-Pub 2023. PMID: 36801912.
Westin SN, Fu S, Tsimberidou A, Piha-Paul S, Akhmedzhanov F, Yilmaz B, McQuinn L, Brink AL, Gong J, Leung CH, Lin H, Hong DS, Pant S, Carter B, Jazaeri A, Gershenson D, Sood AK, Coleman RL, Shah J, Meric-Bernstam F, Naing A. Selinexor in combination with weekly paclitaxel in patients with metastatic solid tumors: Results of an open label, single-center, multi-arm phase 1b study with expansion phase in ovarian cancer. Gynecol Oncol 168:76-82, 2023. e-Pub 2023. PMID: 36423446.
Moyers JT, Carmagnani Pestana R, Roszik J, Hong DS, Naing A, Fu S, Piha-Paul S, Yap T, Karp D, Rodon J, Livingston JA, Zarzour MA, Ravi V, Patel S, Benjamin RS, Ludwig J, Herzog C, Ratan R, Somaiah N, Conley A, Gorlick R, Meric-Bernstam F, Subbiah V. Examining Stripes on a Herd of Zebras: Impact of Genomic Matching for Ultrarare Sarcomas in Phase 1 Clinical Trials (SAMBA 102). Clin Cancer Res 29(2):401-109, 2023. e-Pub 2023. PMID: 36288393.
Yap TA, Daver N, Mahendra M, Zhang J, Kamiya-Matsuoka C, Meric-Bernstam F, Kantarjian HM, Ravandi F, Collins ME, Francesco MED, Dumbrava EE, Fu S, Gao S, Gay JP, Gera S, Han J, Hong DS, Jabbour EJ, Ju Z, Karp DD, Lodi A, Molina JR, Baran N, Naing A, Ohanian M, Pant S, Pemmaraju N, Bose P, Piha-Paul SA, Rodon J, Salguero C, Sasaki K, Singh AK, Subbiah V, Tsimberidou AM, Xu QA, Yilmaz M, Zhang Q, Li Y, Bristow CA, Bhattacharjee MB, Tiziani S, Heffernan TP, Vellano CP, Jones P, Heijnen CJ, Kavelaars A, Marszalek JR, Konopleva M. Complex I inhibitor of oxidative phosphorylation in advanced solid tumors and acute myeloid leukemia: phase I trials. Nat Med 29(1):115-126, 2023. e-Pub 2023. PMID: 36658425.
Steeghs N, Hansen AR, Hanna GJ, Garralda E, Park H, Strauss J, Adam M, Campbell G, Carver J, Easton R, Mays K, Skrdla P, Struemper H, Washburn ML, Matheny C, Piha-Paul SA. Manufacturing-dependent change in biological activity of the TLR4 agonist GSK1795091 and implications for lipid A analog development. CTS-Clin Transl Sci 15(11):2625-2639, 2022. e-Pub 2022. PMID: 36097345.
Piha-Paul S, Simon G, Belani CP, Chao H, Gaspar K, Lee B, Dowlati A. A phase 1, open-label, dose-escalation study of L-DOS47 in combination with pemetrexed plus carboplatin in patients with stage IV recurrent or metastatic nonsquamous NSCLC. JTO Clin Res Rep 3(11):100408, 2022. e-Pub 2022. PMID: 36268537.
Goldman, JW, Martínez Bueno, A, Dooms, C, Jhaveri, K, de Miguel, MJ, Piha-Paul, SA, Unni, N, Mahipal, A, Suga, JM, Naltet, C, Zick, A, Antoñanzas Basa, M, Crown, JP, Chae, YK, DiPrimeo, D, Eli, LD, McCulloch, L, Mahalingam, D. Neratinib efficacy in patients with EGFR exon 18-mutant non-small-cell lung cancer. European Journal of Cancer 174:S82, 2022. e-Pub 2022.
Vo HH, Fu S, Hong DS, Karp DD, Piha-Paul S, Subbiah V, Janku F, Naing A, Yap TA, Rodon J, Ajani JA, Cartwright C, Johnson A, Song IW, Beck J, Kahle M, Nogueras-Gonzalez GM, Miller V, Chao C, Vining DJ, Berry DA, Meric-Bernstam F, Tsimberidou AM. Challenges and opportunities associated with the MD Anderson IMPACT2 randomized study in precision oncology. NPJ Precis Oncol 6(1):78, 2022. e-Pub 2022. PMID: 36302890.
Ravi V, Subramaniam A, Zheng J, Amini B, Trinh VA, Joseph J, Mennel RG, Bishop AJ, Sturgis EM, Goepfert RP, Yalamanchili S, Botello G, Stephen B, Piha-Paul SA, Patel AB, Lazar AJ, Conley AP, Benjamin RS, Patel SR, Futreal PA, Somaiah N, Naing A. Clinical activity of checkpoint inhibitors in angiosarcoma: A retrospective cohort study. Cancer 128(18):3383-3391, 2022. e-Pub 2022. PMID: 35792683.
Goldman JW, Piha-Paul SA, Curti B, Pedersen KS, Bauer TM, Groenland SL, Carvajal RD, Chhaya V, Kirby G, McGlinchey K, Hammond SA, Streicher KL, Townsley D, Chae YK, Voortman J, Marabelle A, Powderly J. Safety and tolerability of MEDI0562, an OX40 agonist monoclonal antibody, in combination with durvalumab or tremelimumab in adult patients with advanced solid tumors. Clin Cancer Res 28(17):3709-3719, 2022. e-Pub 2022. PMID: 35699623.
Mendoza TR, Hong DS, Peterson CB, Stephen B, Dumbrava E, Pant S, Tsimberidou AM, Yap TA, Sheshadri A, Altan M, George G, Castillo L, Rodriguez E, Gong J, Subbiah V, Janku F, Fu S, Piha-Paul SA, Ahnert JR, Karp DD, Cleeland C, Meric-Bernstam F, Naing A. Patient-reported symptom burden in patients with rare cancers receiving pembrolizumab in a phase II Clinical Trial. Sci Rep 12(1):14367, 2022. e-Pub 2022. PMID: 35999229.
Shapira-Frommer R, Mileshkin L, Manzyuk L, Penel N, Burge M, Piha-Paul SA, Girda E, Lopez Martin JA, van Dongen MGJ, Italiano A, Xu L, Jin F, Norwood K, Ott PA. Efficacy and safety of pembrolizumab for patients with previously treated advanced vulvar squamous cell carcinoma: Results from the phase 2 KEYNOTE-158 study. Gynecologic Oncology 166(2):211-218, 2022. e-Pub 2022. PMID: 35361487.
Guo C, Yu Y, Chakrabarti J, Piha-Paul SA, Moroose R, Plotka A, Shi H, Durairaj C, Wang DD, Wainberg ZA. Evaluation of pharmacokinetics and safety of talazoparib in patients with advanced cancer and varying degrees of hepatic impairment. Brit J Clin Pharmaco 88(7):3392-3403, 2022. e-Pub 2022. PMID: 35236002.
Gouda MA, Huang HJ, Piha-Paul SA, Call SG, Karp DD, Fu S, Naing A, Subbiah V, Pant S, Dustin DJ, Tsimberidou AM, Hong DS, Rodon J, Meric-Bernstam F, Janku F. Longitudinal Mnitoring of Circulating Tumor DNA to Predict Treatment Outcomes in Advanced Cancers. JCO Precis Oncol 6:e2100512, 2022. e-Pub 2022. PMID: 35834760.
Nelson BE, Ejezie CL, Stephen BA, Nardo M, Campbell E, Gong J, Hong DS, Fu S, Yap TA, Murphy MB, Piha-Paul S, Daver NG, Rojas-Hernandez CM, Naing A. Spectrum of Immune Checkpoint Inhibitor Anemias: Results From a Single Center, Early-Phase Clinical Trials Case Series Experience. J Hematol 11(3):113-120, 2022. e-Pub 2022. PMID: 35837373.
French CA, Cheng ML, Hanna GJ, DuBois SG, Chau NG, Hann CL, Storck S, Salgia R, Trucco M, Tseng J, Stathis A, Piekarz R, Lauer UM, Massard C, Bennett K, Coker S, Tontsch-Grunt U, Sos ML, Liao S, Wu CJ, Polyak K, Piha-Paul SA, Shapiro GI. Report of the First International Symposium on NUT Carcinoma. Clin Cancer Res 28(12):2493-2505, 2022. e-Pub 2022. PMID: 35417004.
Raghav KP, Stephen B, Karp DD, Piha-Paul SA, Hong DS, Jain D, Chudy Onwugaje DO, Abonofal A, Willett AF, Overman M, Smaglo B, Huey RW, Meric-Bernstam F, Varadhachary GR, Naing A. Efficacy of pembrolizumab in patients with advanced cancer of unknown primary (CUP): a phase 2 non-randomized clinical trial. J Immunother Cancer 10(5), 2022. e-Pub 2022. PMID: 35618285.
Marabelle A, Cassier PA, Fakih M, Kao S, Nielsen D, Italiano A, Guren TK, van Dongen MGJ, Spencer K, Bariani GM, Ascierto PA, Santoro A, Shah M, Asselah J, Iqbal S, Takahashi S, Piha-Paul SA, Ott PA, Chatterjee A, Jin F, Norwood K, Delord JP. Pembrolizumab for previously treated advanced anal squamous cell carcinoma: results from the non-randomised, multicohort, multicentre, phase 2 KEYNOTE-158 study. Lancet Gastroenterol Hepatol 7(5):446-454, 2022. e-Pub 2022. PMID: 35114169.
Yao S, Meric-Bernstam F, Hong D, Janku F, Naing A, Piha-Paul SA, Tsimberidou AM, Karp D, Subbiah V, Yap TA, Ahnert JR, Pant S, Dumbrava EEI, Wathoo C, Campbell E, Yu L, Yamamura Y, Fu S. Clinical characteristics and outcomes of phase I cancer patients with CCNE1 amplification: MD Anderson experiences. Sci Rep 12(1):8701, 2022. e-Pub 2022. PMID: 35610322.
Thein KZ, Karp DD, Tsimberidou A, Gong J, Sulovic S, Shah J, Milton DR, Hong DS, Janku F, McQuinn L, Stephen BA, Colen R, Carter BW, Yap TA, Piha-Paul SA, Fu S, Meric-Bernstam F, Naing A. Selinexor in combination with carboplatin and paclitaxel in patients with advanced solid tumors: Results of a single-center, multi-arm phase Ib study. Invest New Drugs 40(2):290-299, 2022. e-Pub 2022. PMID: 34562230.
Thein KZ, Piha-Paul SA, Tsimberidou A, Karp DD, Janku F, Zarifa A, Shah J, Milton DR, Bean S, McQuinn L, Gong J, Colen R, Carter BW, Subbiah V, Ogbonna DC, Pant S, Meric-Bernstam F, Naing A. Correction to: Selinexor in combination with topotecan in patients with advanced or metastatic solid tumors: Results of an open-label, single-center, multi-arm phase Ib study. Invest New Drugs 40(2):461, 2022. e-Pub 2022. PMID: 34705134.
Thein KZ, Karp DD, Tsimberidou A, Gong J, Sulovic S, Shah J, Milton DR, Hong DS, Janku F, McQuinn L, Stephen BA, Colen R, Carter BW, Yap TA, Piha-Paul SA, Fu S, Meric-Bernstam F, Naing A. Correction to: Selinexor in combination with carboplatin and paclitaxel in patients with advanced solid tumors: results of a single-center, multi-arm phase Ib study. Invest New Drugs 40(2):461, 2022. e-Pub 2022. PMID: 34731355.
Cousin S, Blay JY, Garcia IB, de Bono JS, Le Tourneau C, Moreno V, Trigo J, Hann CL, Azad AA, Im SA, Cassier PA, French CA, Italiano A, Keedy VL, Plummer R, Sablin MP, Hemming ML, Ferron-Brady G, Wyce A, Khaled A, Datta A, Foley SW, McCabe MT, Wu Y, Horner T, Kremer BE, Dhar A, O'Dwyer PJ, Shapiro GI, Piha-Paul SA. Safety, pharmacokinetic, pharmacodynamic and clinical activity of molibresib for the treatment of nuclear protein of the testis carcinoma and other cancers: Results of a Phase I/II open-label, dose escalation study. Int J Cancer 150(6):993-1006, 2022. e-Pub 2022. PMID: 34724226.
Dev R, Zhong LL, Zarifa A, Albittar AA, Rubin L, Liu S, Yap TA, Dalal S, Hui D, Karp DD, Tsimberidou AM, Piha-Paul SA, Ahnert JR, Fu S, Meric-Bernstam F, Naing A. Supportive care for the prevention of nausea, vomiting and anorexia in a phase 1B study of selinexor in advanced cancer patients: an exploratory study. Invest New Drugs 40(1):124-133, 2022. e-Pub 2022. PMID: 34559346.
Thein KZ, Fu S, Janku F, Tsimberidou AM, Piha-Paul SA, Karp DD, Shah J, Milton DR, Gong J, Sulovic S, McQuinn L, Stephen BA, Colen RR, Carter BW, Meric-Bernstam F, Naing A. Selinexor in Combination with Carboplatin and Pemetrexed in Patients with Advanced or Metastatic Solid Tumors: Results of an Open-Label, Single-Center, Multi-Arm Phase 1b Study. J Immunother Precis Oncol 5(1):10-12, 2022. e-Pub 2022. PMID: 35663832.
Kato S, Adashek JJ, Subbiah V, Fu S, Sun M, Nguyen L, Brown EJ, Yap TA, Karp DD, Piha-Paul SA, Hong DS. A phase i study of ixazomib and erlotinib in patients with advanced solid tumors. Invest New Drugs 40(1):99-105, 2022. e-Pub 2022. PMID: 34468905.
Alhalabi O, Hahn AW, Msaouel P, Meric-Bernstam F, Wilson N, Naing A, Piha-Paul S, Janku F, Pant S, Yap TA, Hong DS, Fu S, Karp D, Beltran K, Campbell E, Le H, Campbell MT, Shah A, Tannir NM, Siefker-Radtke A, Gao J, Roszik J, Subbiah V. Validation of Prognostic Scores in Patients With Metastatic Urothelial Cancer Enrolling in Phase I Targeted Therapy or Next Generation Immunotherapy Trials. Clin Genitourin Canc 21(1):e16-e24, 2022. e-Pub 2022. PMID: 34362693.
Yao S, Janku F, Koenig K, Tsimberidou AM, Piha-Paul SA, Shi N, Stewart J, Johnston A, Bomalaski J, Meric-Bernstam F, Fu S. Phase 1 trial of ADI-PEG 20 and liposomal doxorubicin in patients with metastatic solid tumors. Cancer Medicine 11(2):340-347, 2022. e-Pub 2022. PMID: 34841717.
Thein KZ, Piha-Paul SA, Tsimberidou A, Karp DD, Janku F, Fu S, Subbiah V, Hong DS, Yap TA, Shah J, Milton DR, McQuinn L, Gong J, Tran Y, Carter BW, Colen R, Meric-Bernstam F, Naing A. Selinexor in combination with standard chemotherapy in patients with advanced or metastatic solid tumors. Exp Hematol Oncol 10(1):59, 2021. e-Pub 2021. PMID: 34965890.
Akce M, El-Khoueiry A, Piha-Paul SA, Bacque E, Pan P, Zhang ZY, Ewesuedo R, Gupta D, Tang Y, Milton A, Zajic S, Judson PL, O'Bryant CL. Pharmacokinetics and safety of niraparib in patients with moderate hepatic impairment. Cancer Chemother Pharmacol 88(5):825-836, 2021. e-Pub 2021. PMID: 34324028.
Thein KZ, Piha-Paul SA, Tsimberidou A, Karp DD, Janku F, Zarifa A, Shah J, Milton DR, Bean S, McQuinn L, Gong J, Colen R, Carter BW, Subbiah V, Ogbonna DC, Pant S, Meric-Bernstam F, Naing A. Selinexor in combination with topotecan in patients with advanced or metastatic solid tumors: Results of an open-label, single-center, multi-arm phase Ib study. Invest New Drugs 39(5):1357-1365, 2021. e-Pub 2021. PMID: 33909232.
Dumbrava EI, Call SG, Huang HJ, Stuckett AL, Madwani K, Adat A, Hong DS, Piha-Paul SA, Subbiah V, Karp DD, Fu S, Naing A, Tsimberidou AM, Moulder SL, Koenig KH, Barcenas CH, Kee BK, Fogelman DR, Kopetz ES, Meric-Bernstam F, Janku F. PIK3CA mutations in plasma circulating tumor DNA predict survival and treatment outcomes in patients with advanced cancers. ESMO Open 6(5):100230, 2021. e-Pub 2021. PMID: 34479035.
Piha-Paul SA, Azaro A, Arkenau HT, Oh DY, Galsky MD, Pal SK, Hamada K, He Y, Yamamiya I, Benhadji KA, Hollebecque A. A first-in-human phase I study of TAS0728, an oral covalent binding inhibitor of HER2, in patients with advanced solid tumors with HER2 or HER3 aberrations. Invest New Drugs 39(4):1047-1056, 2021. e-Pub 2021. PMID: 33774767.
Piha-Paul SA, Geva R, Tan TJ, Lim DW, Hierro C, Doi T, Rahma O, Lesokhin A, Luke JJ, Otero J, Nardi L, Singh A, Xyrafas A, Chen X, Mataraza J, Bedard PL. First-in-human phase I/Ib open-label dose-escalation study of GWN323 (anti-GITR) as a single agent and in combination with spartalizumab (anti-PD-1) in patients with advanced solid tumors and lymphomas. J Immunother Cancer 9(8), 2021. e-Pub 2021. PMID: 34389618.
Piha-Paul SA, Thein KZ, De Souza P, Kefford R, Gangadhar T, Smith C, Schuster S, Zamboni WC, Dees CE, Markman B. First-in-human, phase I/IIa study of CRLX301, a nanoparticle drug conjugate containing docetaxel, in patients with advanced or metastatic solid malignancies. Invest New Drugs 39(4):1047-1056, 2021. e-Pub 2021. PMID: 33594602.
Ferrarotto R, Sousa LG, Qing Y, Kaya D, Stephen B, Jain D, Bell D, Pant S, Tsimberidou AM, Janku F, Blumenschein G, Glisson BS, Ahnert JR, Piha-Paul SA, Lee JJ, Wong MK, Lu C, Meric-Bernstam F, Naing A. Pembrolizumab in Patients with Refractory Cutaneous Squamous Cell Carcinoma: A Phase II Trial. Adv Ther 38(8):4581-4591, 2021. e-Pub 2021. PMID: 34241781.
Al-Zubidi N, Gombos DS, Hong DS, Subbiah V, Fu S, Ahnert JR, Piha-Paul SA, Tsimberidou AM, Karp DD, Bernstam FM, Naing A. Overview of Ocular Side Effect of Selinexor. Oncologist 26(7):619-623, 2021. e-Pub 2021. PMID: 33728727.
Tsimberidou AM, Vo HH, Subbiah V, Janku F, Piha-Paul SA, Yilmaz B, Gong J, Naqvi MF, Tu SM, Campbell M, Meric-Bernstam F, Naing A. Pembrolizumab in Patients with Advanced Metastatic Germ Cell Tumors. Oncologist 26(7):558-e1098, 2021. e-Pub 2021. PMID: 33491277.
Durairaj C, Chakrabarti J, Ferrario C, Hirte HW, Babu S, Piha-Paul SA, Plotka A, Hoffman J, Shi H, Wang DD. The Effect of Renal Impairment on the Pharmacokinetics and Safety of Talazoparib in Patients with Advanced Solid Tumors. Clin Pharmacokinet 60(7):921-930, 2021. e-Pub 2021. PMID: 33686631.
Huey RW, George GC, Phillips P, White R, Fu S, Janku F, Karp DD, Naing A, Piha-Paul S, Subbiah V, Tsimberidou AM, Pant S, Yap TA, Rodon J, Meric-Bernstam F, Shih YT, Hong DS. Patient-Reported Out-of-Pocket Costs and Financial Toxicity During Early-Phase Oncology Clinical Trials. Oncologist 26(7):588-596, 2021. e-Pub 2021. PMID: 33783054.
Hegde A, Jayaprakash P, Couillault CA, Piha-Paul S, Karp D, Rodon J, Pant S, Fu S, Ileana Dumbrava EE, Yap TA, Subbiah V, Bhosale P, Coarfa C, Higgins JP, Williams ET, Wilson TF, Lim J, Meric-Bernstam F, Sumner E, Zain H, Nguyen D, Nguyen LM, Rajapakshe K, Curran MA, Hong DS. A Phase I Dose Escalation Study to Evaluate the Safety and Tolerability of Evofosfamide in Combination with Ipilimumab in Advanced Solid Malignancies. Clin Cancer Res 27(11):3050-3060, 2021. e-Pub 2021. PMID: 33771853.
Piha-Paul SA, Dumbrava EE, Nair BC, Xiong W, Xu L, Mostorino R, Subbiah V, Tannir N, Fu S, Naing A, Janku F, Karp DD, Patel S, Daw NC, Hong D, Meric-Bernstam F, Zinner R. A Phase I Trial of the MET/ALK/ROS1 Inhibitor Crizotinib Combined with the VEGF Inhibitor Pazopanib in Patients with Advanced Solid Malignancies. OncoTargets Ther 14:3037-3049, 2021. e-Pub 2021. PMID: 33994796.
Cascone T, Sacks RL, Subbiah IM, Drobnitzky N, Piha-Paul SA, Hong DS, Hess KR, Amini B, Bhatt T, Fu S, Naing A, Janku F, Karp D, Falchook GS, Conley AP, Sherman SI, Meric-Bernstam F, Ryan AJ, Heymach JV, Subbiah V. Safety and activity of vandetanib in combination with everolimus in patients with advanced solid tumors: a phase I study. ESMO Open 6(2):100079, 2021. e-Pub 2021. PMID: 33721621.
Yao S, Janku F, Subbiah V, Stewart J, Patel SP, Kaseb A, Westin SN, Naing A, Tsimberidou AM, Hong D, Piha-Paul SA, Shi N, Johnston A, Bomalaski J, Fu S. Phase 1 trial of ADI-PEG20 plus cisplatin in patients with pretreated metastatic melanoma or other advanced solid malignancies. Br J Cancer 124(9):1533-1539, 2021. e-Pub 2021. PMID: 33674736.
Tsimberidou AM, Hong DS, Fu S, Karp DD, Piha-Paul S, Kies MS, Ravi V, Subbiah V, Patel SM, Tu SM, Janku F, Heymach J, Johnson A, Cartwright C, Zhao L, Zhang J, Berry DA, Vining DJ, Futreal A, Miller VA, Meric-Bernstam F. Precision medicine: preliminary results from the Initiative for Molecular Profiling and Advanced Cancer Therapy 2 (IMPACT2) study. NPJ Precis Oncol 5(1):21, 2021. e-Pub 2021. PMID: 33742104.
Zhao M, Scott S, Evans KW, Yuca E, Saridogan T, Zheng X, Wang H, Korkut A, Cruz Pico CX, Demirhan M, Kirby B, Kopetz S, Diala I, Lalani AS, Piha-Paul S, Meric-Bernstam F. Combining Neratinib with CDK4/6, mTOR, and MEK Inhibitors in Models of HER2-positive Cancer. Clin Cancer Res 27(6):1681-1694, 2021. e-Pub 2021. PMID: 33414137.
Alhalabi O, Hahn AW, Msaouel P, Andreev-Drakhlin AY, Meric-Bernstam F, Naing A, Piha-Paul S, Filip J, Pant S, Yap TA, Hong DS, Fu S, Karp D, Campbell E, Le H, Campbell MT, Shah AY, Tannir NM, Siefker-Radtke AO, Gao J, Roszik J, Subbiah V. Molecular profiling of metastatic bladder cancer early-phase clinical trial participants predicts patient outcomes. Mol Cancer Res 19(3):395-402, 2021. e-Pub 2021. PMID: 33323389.
Ballhausen A, Wheler JJ, Karp DD, Piha-Paul SA, Fu S, Pant S, Tsimberidou AM, Hong DS, Subbiah V, Holley VR, Huang H, Brewster AM, Koenig KB, Ibrahim NK, Meric-Bernstam F, Janku F. Phase I study of everolimus, letrozole, and trastuzumab in patients with hormone receptor-positive metastatic breast cancer or other solid tumors. Clin Cancer Res 27(5):1247-1255, 2021. e-Pub 2021. PMID: 33115815.
Hajjar J, Mendoza T, Zhang L, Fu S, Piha-Paul SA, Hong DS, Janku F, Karp DD, Ballhausen A, Gong J, Zarifa A, Peterson CB, Meric-Bernstam F, Jenq R, Naing A. Associations between the gut microbiome and fatigue in cancer patients. Sci Rep 11(1):5847, 2021. e-Pub 2021. PMID: 33712647.
How JA, Jazaeri AA, Soliman PT, Fleming ND, Gong J, Piha-Paul SA, Janku F, Stephen B, Naing A. Pembrolizumab in vaginal and vulvar squamous cell carcinoma: a case series from a phase II basket trial. Sci Rep 11(1):3667, 2021. e-Pub 2021. PMID: 33574401.
Janku F, Sakamuri D, Kato S, Huang HJ, Call SG, Naing A, Holley VR, Patel SP, Amaria RN, Falchook GS, Piha-Paul SA, Zinner RG, Tsimberidou AM, Hong DS, Meric-Bernstam F. Dose-escalation study of vemurafenib with sorafenib or crizotinib in patients with BRAF-mutated advanced cancers. Cancer 127(3):391-402, 2021. e-Pub 2021. PMID: 33119140.
Janku F, Zhang HH, Pezeshki A, Goel S, Murthy R, Wang-Gillam A, Shepard DR, Helgason T, Masters T, Hong DS, Piha-Paul SA, Karp DD, Klang M, Huang SY, Sakamuri D, Raina A, Torrisi J, Solomon SB, Weissfeld A, Trevino E, DeCrescenzo G, Collins A, Miller M, Salstrom JL, Korn RL, Zhang L, Saha S, Leontovich AA, Tung D, Kreider B, Varterasian M, Khazaie K, Gounder MM. Intratumoral injection of clostridium novyi-NT spores in patients with treatment-refractory advanced solid tumors. Clin Cancer Res 27(1):96-106, 2021. e-Pub 2021. PMID: 33046513.
Zou F, Abu-Sbeih H, Ma W, Peng Y, Qiao W, Wang J, Shah AY, Glitza Oliva IC, Piha-Paul SA, Thompson JA, Zhang HC, Thomas AS, Wang Y. Association of chronic immune-mediated diarrhea and colitis with favorable cancer response. J Natl Compr Canc Netw 19(6):700-708, 2020. e-Pub 2020. PMID: 33316767.
Janku F, Park H, Call SG, Madwani K, Oki Y, Subbiah V, Hong DS, Naing A, Velez-Bravo VM, Barnes TG, Hagemeister FB, Falchook GS, Karp DD, Wheler JJ, Piha-Paul SA, Garrido-Laguna I, Shpall EJ, Fayad LE, Neelapu SS, Meric-Bernstam F, Kurzrock R, Fanale MA. Safety and efficacy of vorinostat plus sirolimus or everolimus in patients with relapsed refractory Hodgkin Lymphoma. Clin Cancer Res 26(21):5579-5587, 2020. e-Pub 2020. PMID: 33055173.
Hahn AW, Alhalabi O, Msaouel P, Meric-Bernstam F, Naing A, Jonasch E, Piha-Paul S, Hong D, Pant S, Yap T, Campbell E, Le H, Tannir NM, Roszik J, Subbiah V. Validation of prognostic scoring systems for patients with metastatic renal cell carcinoma enrolled in phase I clinical trials. ESMO Open 5(6), 2020. e-Pub 2020. PMID: 33229506.
Marabelle A, Fakih M, Lopez J, Shah M, Shapira-Frommer R, Nakagawa K, Chung HC, Kindler HL, Lopez-Martin JA, Miller WH, Italiano A, Kao S, Piha-Paul SA, Delord JP, McWilliams RR, Fabrizio DA, Aurora-Garg D, Xu L, Jin F, Norwood K, Bang YJ. Association of tumour mutational burden with outcomes in patients with advanced solid tumours treated with pembrolizumab: prospective biomarker analysis of the multicohort, open-label, phase 2 KEYNOTE-158 study. Lancet Oncol 21(10):1353-1365, 2020. e-Pub 2020. PMID: 32919526.
Piha-Paul SA, Oh DY, Ueno M, Malka D, Chung HC, Nagrial A, Kelley RK, Ros W, Italiano A, Nakagawa K, Rugo HS, de Braud F, Varga AI, Hansen A, Wang H, Krishnan S, Norwood KG, Doi T. Efficacy and safety of pembrolizumab for the treatment of advanced biliary cancer: Results from the KEYNOTE-158 and KEYNOTE-028 studies. Int J Cancer 147(8):2190-2198, 2020. e-Pub 2020. PMID: 32359091.
Mendoza T, Sheshadri A, Altan M, Hess K, George G, Stephen B, Castillo L, Rodriguez E, Gong J, Peterson C, Rodon Ahnert J, Fu S, Piha-Paul SA, Pant S, Dumbrava E, Yap TA, Janku F, Tsimberidou AM, Subbiah V, Karp DD, Zarifa A, McQuinn LM, Cleeland C, Hong DS, Naing A. Evaluating the psychometric properties of the Immunotherapy module of the MD Anderson Symptom Inventory. J Immunother Cancer 8(2), 2020. e-Pub 2020. PMID: 33097611.
Naing A, Eder JP, Piha-Paul SA, Gimmi C, Hussey E, Zhang S, Hildebrand V, Hosagrahara V, Habermehl C, Moisan J, Papadopoulos KP. Preclinical investigations and a first-in-human phase I trial of M4112, the first dual inhibitor of indoleamine 2,3-dioxygenase 1 and tryptophan 2,3-dioxygenase 2, in patients with advanced solid tumors. J Immunother Cancer 8(2), 2020. e-Pub 2020. PMID: 32843490.
George GC, Mendoza TR, Iwuanyanwu EC, Manandhar M, Afshar SF, Piha-Paul SA, Tsimberidou A, Naing A, Cleeland CS, Hong DS. Factors affecting symptom presentation in an early-phase clinical trials clinic patient population. Invest New Drugs 38(4):1166-1174, 2020. e-Pub 2020. PMID: 31761957.
Mehnert JM, Bergsland E, O'Neil BH, Santoro A, Schellens JHM, Cohen RB, Doi T, Ott PA, Pishvaian MJ, Puzanov I, Aung KL, Hsu C, Le Tourneau C, Hollebecque A, Élez E, Tamura K, Gould M, Yang P, Stein K, Piha-Paul SA. Pembrolizumab for the treatment of programmed death-ligand 1-positive advanced carcinoid or pancreatic neuroendocrine tumors: Results from the KEYNOTE-028 study. Cancer 126(13):3021-3030, 2020. e-Pub 2020. PMID: 32320048.
Strosberg J, Mizuno N, Doi T, Grande E, Delord JP, Shapira-Frommer R, Bergsland E, Shah M, Fakih M, Takahashi S, Piha-Paul SA, O'Neil B, Thomas S, Lolkema MP, Chen M, Ibrahim N, Norwood K, Hadoux J. Efficacy and Safety of Pembrolizumab in Previously Treated Advanced Neuroendocrine Tumors: Results From the Phase 2 KEYNOTE-158 Study. Clin Cancer Res 26(9):2124-2130, 2020. e-Pub 2020. PMID: 31980466.
Chung HC, Piha-Paul SA, Lopez-Martin J, Schellens JHM, Kao S, Miller WH, Delord JP, Gao B, Planchard D, Gottfried M, Zer A, Jalal SI, Penel N, Mehnert JM, Matos I, Bennouna J, Kim DW, Xu L, Krishnan S, Norwood K, Ott PA. Pembrolizumab After Two or More Lines of Previous Therapy in Patients With Recurrent or Metastatic Small-Cell Lung Cancer: Results From the KEYNOTE-028 and KEYNOTE-158 Studies. J Thorac Oncol 15(4):618-627, 2020. e-Pub 2020. PMID: 31870883.
Piha-Paul SA, Hann CL, French CA, Cousin S, Braña I, Cassier PA, Moreno V, de Bono JS, Harward SD, Ferron-Brady G, Barbash O, Wyce A, Wu Y, Horner T, Annan M, Parr NJ, Prinjha RK, Carpenter CL, Hilton J, Hong DS, Haas NB, Markowski MC, Dhar A, O'Dwyer PJ, Shapiro GI. Phase 1 Study of Molibresib (GSK525762), a Bromodomain and Extra-Terminal Domain Protein Inhibitor, in NUT Carcinoma and Other Solid Tumors. JNCI Cancer Spectr 4(2):pkz093, 2020. e-Pub 2020. PMID: 32328561.
Taylor MH, Alva AS, Larson T, Szpakowski S, Purkaystha D, Amin A, Karpiak L, Piha-Paul SA. A mutation-specific, single-arm, phase 2 study of dovitinib in patients with advanced malignancies. Oncotarget 11(14):1235-1243, 2020. e-Pub 2020. PMID: 32292573.
Mukhtar E, Worroll D, Galletti G, Schuster S, Piha-Paul SA, Giannakakou P. Quantitative analysis of taxane drug target engagement of microtubules in circulating tumor cells from metastatic castration resistant prostate cancer patients treated with CRXL301, a nanoparticle of docetaxel. Cancer Drug Resist 3(3):636-646, 2020. e-Pub 2020. PMID: 33062959.
Falchook GS, Kurzrock R, Amin HM, Xiong W, Fu S, Piha-Paul SA, Janku F, Eskandari G, Catenacci DVT, Klevesath MB, Bruns R, Stammberger U, Johne A, Bladt F, Friese-Hamim M, Girard P, El Bawab S, Hong DS. First-in-man phase I trial of the selective MET inhibitor Tepotinib in patients with advanced solid tumors. Clin Cancer Res 26(6):1237-1246, 2020. e-Pub 2020. PMID: 31822497.
Naing A, Meric-Bernstam F, Stephen B, Karp DD, Hajjar J, Rodon Ahnert J, Piha-Paul SA, Colen RR, Jimenez C, Raghav KP, Ferrarotto R, Tu SM, Campbell M, Wang L, Sabir SH, Tapia C, Bernatchez C, Frumovitz M, Tannir N, Ravi V, Khan S, Painter JM, Abonofal A, Gong J, Alshawa A, McQuinn LM, Xu M, Ahmed S, Subbiah V, Hong DS, Pant S, Yap TA, Tsimberidou AM, Dumbrava EEI, Janku F, Fu S, Simon RM, Hess KR, Varadhachary GR, Amir Habra M. Phase 2 study of pembrolizumab in patients with advanced rare cancers. J Immunother Cancer 8(1), 2020. e-Pub 2020. PMID: 32188704.
Falchook GS, Rosen S, LoRusso PM, Watts JM, Gupta S, Coombs CC, Talpaz M, Kurzrock R, Mita MM, Cassaday RD, Harb W, Peguero JA, Smith DC, Piha-Paul SA, Szmulewitz RZ, Noel MS, Yeleswaram S, Liu P, Switzky J, Zhou G, Zheng F, Mehta AN. Development of 2 bromodomain and extraterminal inhibitors with distinct pharmacokinetic and pharmacodynamic profiles for the treatment of advanced malignancies. Clin Cancer Res 26(6):1247-1257, 2020. e-Pub 2020. PMID: 31527168.
Wang Y, Janku F, Piha-Paul S, Hess K, Broaddus R, Liu L, Shi N, Overman M, Kopetz S, Subbiah V, Naing A, Hong D, Tsimberidou AM, Karp D, Yao J, Fu S. Phase I studies of vorinostat with ixazomib or pazopanib imply a role of antiangiogenesis-based therapy for TP53 mutant malignancies. Sci Rep 10(1):3080, 2020. e-Pub 2020. PMID: 32080210.
Smyth LM, Piha-Paul SA, Won HH, Schram AM, Saura C, Loi S, Lu J, Shapiro GI, Juric D, Mayer IA, Arteaga CL, de la Fuente MI, Brufksy AM, Spanggaard I, Mau-Sorensen M, Arnedos M, Moreno V, Boni V, Sohn J, Schwartzberg LS, Gonzalez-Farre X, Cervantes A, Bidard FC, Gorelick AN, Lanman RB, Nagy RJ, Ulaner GA, Chandarlapaty S, Jhaveri K, Gavrila EI, Zimel C, Selcuklu SD, Melcer M, Samoila A, Cai Y, Scaltriti M, Mann G, Xu F, Eli LD, Dujka M, Lalani AS, Bryce R, Baselga J, Taylor BS, Solit DB, Meric-Bernstam F, Hyman DM. Efficacy and determinants of response to HER kinase inhibition in HER2-mutant metastatic breast cancer. Cancer Discov 10(2):198-213, 2020. e-Pub 2020. PMID: 31806627.
Marabelle A, Le DT, Ascierto PA, Di Giacomo AM, De Jesus-Acosta A, Delord JP, Geva R, Gottfried M, Penel N, Hansen AR, Piha-Paul SA, Doi T, Gao B, Chung HC, Lopez-Martin J, Bang YJ, Frommer RS, Shah M, Ghori R, Joe AK, Pruitt SK, Diaz LA. Efficacy of pembrolizumab in patients with noncolorectal high microsatellite instability/mismatch repair-deficient cancer: results from the phase II KEYNOTE-158 study. J Clin Oncol 38(1):1-10, 2020. e-Pub 2020. PMID: 31682550.
Subbiah V, Dumbrava EI, Jiang Y, Thein KZ, Naing A, Hong DS, Fu S, Piha-Paul SA, Tsimberidou AM, Janku F, Meric-Bernstam F, Kurzrock R, Falchook G. Dual EGFR blockade with cetuximab and erlotinib combined with anti-VEGF antibody bevacizumab in advanced solid tumors: a phase 1 dose escalation triplet combination trial. Exp Hematol Oncol 9:7, 2020. e-Pub 2020. PMID: 32337094.
Sakellaropoulos T, Vougas K, Narang S, Koinis F, Kotsinas A, Polyzos A, Moss TJ, Piha-Paul S, Zhou H, Kardala E, Damianidou E, Alexopoulos LG, Aifantis I, Townsend PA, Panayiotidis MI, Sfikakis P, Bartek J, Fitzgerald RC, Thanos D, Mills Shaw KR, Petty R, Tsirigos A, Gorgoulis VG. A deep learning framework for predicting response to therapy in cancer. Cell Rep 29(11):3367-3373.e4, 2019. e-Pub 2019. PMID: 31825821.
Ulaner GA, Saura C, Piha-Paul SA, Mayer IA, Quinn DI, Jhaveri K, Stone B, Shahin S, Mann G, Dujka M, Bryce R, Meric-Bernstam F, Solit DB, Hyman DM. Impact of FDG PET imaging for expanding patient eligibility & measuring treatment response in a genome-driven basket trial of the pan-HER kinase inhibitor, Neratinib. Clin Cancer Res 25(24):7381-7387, 2019. e-Pub 2019. PMID: 31548342.
Tsimberidou AM, Hong DS, Wheler JJ, Falchook GS, Janku F, Naing A, Fu S, Piha-Paul SA, Cartwright C, Broaddus RR, Nogueras Gonzalez GM, Hwu P, Kurzrock R. Long-term overall survival and prognostic score predicting survival: the IMPACT study in precision medicine. J Hematol Oncol 12(1):145, 2019. e-Pub 2019. PMID: 31888672.
Piha-Paul SA, Taylor MH, Spitz D, Schwartzberg L, Beck JT, Bauer TM, Meric-Bernstam F, Purkayastha D, Karpiak L, Szpakowski S, Braiteh F. Efficacy and safety of buparlisib, a PI3K inhibitor, in patients with malignancies harboring a PI3K pathway activation: a phase 2, open-label, single-arm study. Oncotarget 10(60):6526-6535, 2019. e-Pub 2019. PMID: 31741715.
Piha-Paul SA, Sachdev JC, Barve M, LoRusso PM, Szmulewitz RZ, Patel SP, Lara PN, Chen X, Hu B, Freise KJ, Modi D, Sood A, Hutti JE, Wolff J, O'Neil BH. First-in-human Study of Mivebresib (ABBV-075), an Oral Pan-inhibitor of Bromodomain and Extra Terminal Proteins, in Patients with Relapsed/Refractory Solid Tumors. Clin Cancer Res 25(21):6309-6319, 2019. e-Pub 2019. PMID: 31420359.
Maymani H, Hess K, Groisberg R, Hong DS, Naing A, Piha-Paul S, Janku F, Fu S, Tsimberidou AM, Pant S, Karp D, Liu S, Sun M, Heymach J, Simon G, Meric-Bernstam F, Subbiah V. Corrigendum to "Predicting outcomes in patients with advanced non-small cell lung cancer enrolled in early phase immunotherapy trials" [Lung Cancer 120 (June) (2018) 137-141]. Lung Cancer 136:158, 2019. e-Pub 2019. PMID: 31445783.
Ding Q, Chen H, Lim B, Damodaran S, Chen W, Tripathy D, Piha-Paul S, Luthra R, Meric-Bernstam F, Sahin AA. HER2 somatic mutation analysis in breast cancer: correlation with clinicopathological features. Hum Pathol 92:32-38, 2019. e-Pub 2019. PMID: 31351155.
Xing Y, Lin NU, Maurer MA, Chen H, Mahvash A, Sahin A, Akcakanat A, Li Y, Abramson V, Litton J, Chavez-MacGregor M, Valero V, Piha-Paul SA, Hong D, Do KA, Tarco E, Riall D, Eterovic AK, Wulf GM, Cantley LC, Mills GB, Doyle LA, Winer E, Hortobagyi GN, Gonzalez-Angulo AM, Meric-Bernstam F. Phase II trial of AKT inhibitor MK-2206 in patients with advanced breast cancer who have tumors with PIK3CA or AKT mutations, and/or PTEN loss/PTEN mutation. Breast Cancer Res 21(1):78, 2019. e-Pub 2019. PMID: 31277699.
Chung HC, Ros W, Delord JP, Perets R, Italiano A, Shapira-Frommer R, Manzuk L, Piha-Paul SA, Xu L, Zeigenfuss S, Pruitt SK, Leary A. Efficacy and safety of pembrolizumab in previously treated advanced cervical cancer: results from the phase II KEYNOTE-158 study. J Clin Oncol 37(17):1470-1478, 2019. e-Pub 2019. PMID: 30943124.
Doan HQ, Hu MI, Goldstein J, Piha-Paul SA, Subbiah V, Patel AB. Vandetanib photoinduced cutaneous toxicities. Cutis 103(5):E24-E29, 2019. e-Pub 2019. PMID: 31233590.
Meric-Bernstam F, Johnson A, Ileana Dumbrava EE, Raghav K, Balaji K, Bhatt M, Murthy RK, Rodon J, Piha-Paul SA. Advances in HER2-targeted therapy: novel agents and opportunities beyond breast and gastric cancer. Clin Cancer Res 25(7):2033-2041, 2019. e-Pub 2019. PMID: 30442682.
George GC, Iwuanyanwu EC, Buford AS, Piha-Paul SA, Subbiah V, Fu S, Karp DD, Pant S, Hinojosa CO, Hess KR, Cleeland CS, Bernstam EV, Meric-Bernstam F, Hong DS. Cancer-related internet use and Its association with patient decision making and trust in physicians among patients in an early drug development clinic: a questionnaire-based cross-sectional observational study. J Med Internet Res 21(3):e10348, 2019. e-Pub 2019. PMID: 30869638.
Mehnert JM, Varga A, Brose MS, Aggarwal RR, Lin CC, Prawira A, de Braud F, Tamura K, Doi T, Piha-Paul SA, Gilbert J, Saraf S, Thanigaimani P, Cheng JD, Keam B. Safety and antitumor activity of the anti-PD-1 antibody pembrolizumab in patients with advanced, PD-L1-positive papillary or follicular thyroid cancer. BMC Cancer 19(1):196, 2019. e-Pub 2019. PMID: 30832606.
Varga A, Piha-Paul S, Ott PA, Mehnert JM, Berton-Rigaud D, Morosky A, Yang P, Ruman J, Matei D. Pembrolizumab in patients with programmed death ligand 1-positive advanced ovarian cancer: Analysis of KEYNOTE-028. Gynecol Oncol 152(2):243-250, 2019. e-Pub 2019. PMID: 30522700.
Hyman DM, Piha-Paul SA, Won H, Rodon J, Saura C, Shapiro GI, Juric D, Quinn DI, Moreno V, Doger B, Mayer IA, Boni V, Calvo E, Loi S, Lockhart AC, Erinjeri JP, Scaltriti M, Ulaner GA, Patel J, Tang J, Beer H, Selcuklu SD, Hanrahan AJ, Bouvier N, Melcer M, Murali R, Schram AM, Smyth LM, Jhaveri K, Li BT, Drilon A, Harding JJ, Iyer G, Taylor BS, Berger MF, Cutler RE, Xu F, Butturini A, Eli LD, Mann G, Farrell C, Lalani AS, Bryce RP, Arteaga CL, Meric-Bernstam F, Baselga J, Solit DB. Author Correction: HER kinase inhibition in patients with HER2- and HER3-mutant cancers. Nature 566(7745):E11-E12, 2019. e-Pub 2019. PMID: 30755741.
Bhatty M, Kato S, Piha-Paul SA, Naing A, Subbiah V, Huang HJ, Karp DD, Tsimberidou AM, Zinner RG, Hwu WJ, Javle M, Patel SP, Hu MI, Varadhachary GR, Conley AP, Ramzanali NM, Holley VR, Kurzrock R, Meric-Bernstam F, Kwang Chae Y, Kim KB, Falchook GS, Janku F. Phase 1 study of the combination of vemurafenib, carboplatin, and paclitaxel in patients with BRAF-mutated melanoma and other advanced malignancies. Cancer 125(3):463-472, 2019. e-Pub 2019. PMID: 30383888.
Ott PA, Bang YJ, Piha-Paul SA, Razak ARA, Bennouna J, Soria JC, Rugo HS, Cohen RB, O'Neil BH, Mehnert JM, Lopez J, Doi T, van Brummelen EMJ, Cristescu R, Yang P, Emancipator K, Stein K, Ayers M, Joe AK, Lunceford JK. T-Cell-Inflamed Gene-Expression Profile, Programmed Death Ligand 1 Expression, and Tumor Mutational Burden Predict Efficacy in Patients Treated With Pembrolizumab Across 20 Cancers: KEYNOTE-028. J Clin Oncol 37(4):318-327, 2019. e-Pub 2019. PMID: 30557521.
Dumbrava EI, Brusco L, Daniels M, Wathoo C, Shaw K, Lu K, Zheng X, Strong L, Litton J, Arun B, Eterovic AK, Routbort M, Patel K, Qi Y, Piha-Paul S, Subbiah V, Hong D, Rodon J, Kopetz S, Mendelsohn J, Mills GB, Chen K, Meric-Bernstam F. Expanded analysis of secondary germline findings from matched tumor/normal sequencing identifies additional clinically significant mutations. JCO Precis Oncol 3, 2019. e-Pub 2019. PMID: 31517177.
Dumbrava EEI, Balaji K, Raghav K, Hess K, Javle M, Blum-Murphy M, Ajani J, Kopetz S, Broaddus R, Routbort M, Demirhan M, Zheng X, Pant S, Tsimberidou AM, Subbiah V, Hong DS, Rodon J, Shaw KM, Piha-Paul SA, Meric-Bernstam F. Targeting ERBB2 (HER2) Amplification Identified by Next-Generation Sequencing in Patients With Advanced or Metastatic Solid Tumors Beyond Conventional Indications. JCO Precis Oncol 3, 2019. e-Pub 2019. PMID: 32923865.
George GC, Buford A, Hess K, Piha-Paul SA, Zinner R, Subbiah V, Hinojosa C, Cleeland CS, Meric-Bernstam F, Bernstam EV, Hong DS. Cancer-Related Internet Use and Online Social Networking Among Patients in an Early-Phase Clinical Trials Clinic at a Comprehensive Cancer Center. JCO Clin Cancer Inform 2:1-14, 2018. e-Pub 2018. PMID: 30652565.
Cohen RB, Delord JP, Doi T, Piha-Paul SA, Liu SV, Gilbert J, Algazi AP, Damian S, Hong RL, Le Tourneau C, Day D, Varga A, Elez E, Wallmark J, Saraf S, Thanigaimani P, Cheng J, Keam B. Pembrolizumab for the treatment of advanced salivary gland carcinoma: findings of the phase 1b KEYNOTE-028 study. Am J Clin Oncol 41(11):1083-1088, 2018. e-Pub 2018. PMID: 29462123.
Reilley MJ, McCoon P, Cook C, Lyne P, Kurzrock R, Kim Y, Woessner R, Younes A, Nemunaitis J, Fowler N, Curran M, Liu Q, Zhou T, Schmidt J, Jo M, Lee SJ, Yamashita M, Hughes SG, Fayad L, Piha-Paul S, Nadella MVP, Xiao X, Hsu J, Revenko A, Monia BP, MacLeod AR, Hong DS. STAT3 antisense oligonucleotide AZD9150 in a subset of patients with heavily pretreated lymphoma: results of a phase 1b trial. J Immunother Cancer 6(1):119, 2018. e-Pub 2018. PMID: 30446007.
Fountzilas E, Krishnan E, Janku F, Fu S, Karp DD, Naing A, Subbiah V, Hong DS, Piha-Paul SA, Vining DJ, Tsimberidou AM. A phase I clinical trial of hepatic arterial infusion of oxaliplatin and oral capecitabine, with or without intravenous bevacizumab, in patients with advanced cancer and predominant liver involvement. Cancer Chemother Pharmacol 82(5):877-885, 2018. e-Pub 2018. PMID: 30182147.
Dembla V, Somaiah N, Barata P, Hess K, Fu S, Janku F, Karp DD, Naing A, Piha-Paul SA, Subbiah V, Tsimberidou AM, Shaw K, Meric-Bernstam F, Hong DS. Prevalence of MDM2 amplification and coalterations in 523 advanced cancer patients in the MD Anderson phase 1 clinic. Oncotarget 9(69):33232-33243, 2018. e-Pub 2018. PMID: 30237864.
Wang Y, Wang Z, Piha-Paul S, Janku F, Subbiah V, Shi N, Hess K, Broaddus R, Shan B, Naing A, Hong D, Tsimberidou AM, Karp D, Lu C, Papadimitrakopoulou V, Heymach J, Meric-Bernstam F, Fu S. Outcome analysis of phase I trial patients with metastatic KRAS and/or TP53 mutant non-small cell lung cancer. Oncotarget 9(70):33258-33270, 2018. e-Pub 2018. PMID: 30279957.
Hansen AR, Massard C, Ott PA, Haas NB, Lopez JS, Ejadi S, Wallmark JM, Keam B, Delord JP, Aggarwal R, Gould M, Yang P, Keefe SM, Piha-Paul SA. Pembrolizumab for advanced prostate adenocarcinoma: findings of the KEYNOTE-028 study. Ann Oncol 29(8):1807-1813, 2018. e-Pub 2018. PMID: 29992241.
Fujii T, Colen RR, Bilen MA, Hess KR, Hajjar J, Suarez-Almazor ME, Alshawa A, Hong DS, Tsimberidou A, Janku F, Gong J, Stephen B, Subbiah V, Piha-Paul SA, Fu S, Sharma P, Mendoza T, Patel A, Thirumurthi S, Sheshadri A, Meric-Bernstam F, Naing A. Incidence of immune-related adverse events and its association with treatment outcomes: the MD Anderson Cancer Center experience. Invest New Drugs 36(4):638-646, 2018. e-Pub 2018. PMID: 29159766.
Subbiah V, Murthy R, Hong DS, Prins RM, Hosing C, Hendricks K, Kolli D, Noffsinger L, Brown R, McGuire M, Fu S, Piha-Paul S, Naing A, Conley AP, Benjamin RS, Kaur I, Bosch ML. Cytokines produced by dendritic cells administered intratumorally correlate with clinical outcome in patients with diverse cancers. Clin Cancer Res 24(16):3845-3856, 2018. e-Pub 2018. PMID: 30018119.
Parseghian CM, Patnana M, Bhosale P, Hess KR, Shih YT, Kim B, Kopetz S, Overman MJ, Varadhachary GR, Javle M, Naing A, Piha-Paul S, Hong D, Le H, Subbiah V, Pant S. Evaluating for pseudoprogression in colorectal and pancreatic tumors Treated with immunotherapy. J Immunother 41(6):284-291, 2018. e-Pub 2018. PMID: 29668571.
Liu L, Toung JM, Jassowicz AF, Vijayaraghavan R, Kang H, Zhang R, Kruglyak KM, Huang HJ, Hinoue T, Shen H, Salathia N, Hong DS, Naing A, Subbiah V, Piha-Paul SA, Bibikova M, Granger G, Barnes B, Shen R, Gutekunst K, Fu S, Tsimberidou AM, Lu C, Eng C, Moulder SL, Kopetz ES, Amaria RN, Meric-Bernstam F, Laird PW, Fan JB, Janku F. Targeted methylation sequencing of plasma cell-free DNA for cancer detection and classification. Ann Oncol 29(6):1445-1453, 2018. e-Pub 2018. PMID: 29635542.
Maymani H, Hess K, Groisberg R, Hong DS, Naing A, Piha-Paul S, Janku F, Fu S, Tsimberidou AM, Pant S, Karp D, Liu S, Sun M, Heymach J, Simon G, Meric-Bernstam F, Subbiah V. Predicting outcomes in patients with advanced non-small cell lung cancer enrolled in early phase immunotherapy trials. Lung Cancer 120:137-141, 2018. e-Pub 2018. PMID: 29748008.
Rugo HS, Delord JP, Im SA, Ott PA, Piha-Paul SA, Bedard PL, Sachev J, Le Tourneau C, van Brummelen EMJ, Varga A, Salgado R, Loi S, Saraf S, Pietrangelo D, Karantza V, Tan AR. Safety and antitumor activity of pembrolizumab in patients with estrogen receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer. Clin Cancer Res 24(12):2804-2811, 2018. e-Pub 2018. PMID: 29559561.
Kato S, Jardim DL, Johnson FM, Subbiah V, Piha-Paul S, Tsimberidou AM, Falchook GS, Karp D, Zinner R, Wheler J, Janku F, Fu S, Lim J, Bean S, Nguyen L, Urban S, Browne E, Meric-Bernstam F, Hong DS. Phase I study of the combination of crizotinib (as a MET inhibitor) and dasatinib (as a c-SRC inhibitor) in patients with advanced cancer. Invest New Drugs 36(3):416-423, 2018. e-Pub 2018. PMID: 29047029.
Sen S, Kato S, Agarwal R, Piha-Paul S, Hess K, Karp D, Janku F, Fu S, Naing A, Pant S, Falchook G, Tang C, Wu X, Ye Y, Tsimberidou A, Subbiah V, Kurzrock R, Byers L, Westin S, Lim J, Bean S, Bass A, Nguyen L, Meric-Bernstam F, Hong D. Phase I study of nab-paclitaxel, gemcitabine, and bevacizumab in patients with advanced cancers. Br J Cancer 118(11):1419-1424, 2018. e-Pub 2018. PMID: 29695765.
Maitland ML, Piha-Paul SA, Falchook G, Kurzrock R, Nguyen L, Janisch L, Karovic S, McKee M, Hoening E, Wong S, Munasinghe W, Palma J, Donawho C, Lian GK, Ansell P, Ratain MJ, Hong DS. Clinical pharmacodynamic/exposure characterisation of the multikinase inhibitor ilorasertib (ABT-348) in a phase I dose-escalation trial. Br J Cancer 118(8):1042-1050, 2018. e-Pub 2018. PMID: 29551775.
Slosberg ED, Kang BP, Peguero J, Taylor M, Bauer TM, Berry DA, Braiteh F, Spira A, Meric-Bernstam F, Stein S, Piha-Paul SA, Salvado A. Signature program: a platform of basket trials. Oncotarget 9(30):21383-21395, 2018. e-Pub 2018. PMID: 29765547.
Sen S, Hess K, Hong DS, Naing A, Piha-Paul S, Janku F, Fu S, Subbiah IM, Liu H, Khanji R, Huang L, Moorthy S, Karp DD, Tsimberidou A, Meric-Bernstam F, Subbiah V. Development of a prognostic scoring system for patients with advanced cancer enrolled in immune checkpoint inhibitor phase 1 clinical trials. Br J Cancer 118(6):763-769, 2018. e-Pub 2018. PMID: 29462132.
Hyman DM, Piha-Paul SA, Won H, Rodon J, Saura C, Shapiro GI, Juric D, Quinn DI, Moreno V, Doger B, Mayer IA, Boni V, Calvo E, Loi S, Lockhart AC, Erinjeri JP, Scaltriti M, Ulaner GA, Patel J, Tang J, Beer H, Selcuklu SD, Hanrahan AJ, Bouvier N, Melcer M, Murali R, Schram AM, Smyth LM, Jhaveri K, Li BT, Drilon A, Harding JJ, Iyer G, Taylor BS, Berger MF, Cutler RE, Xu F, Butturini A, Eli LD, Mann G, Farrell C, Lalani AS, Bryce RP, Arteaga CL, Meric-Bernstam F, Baselga J, Solit DB. HER kinase inhibition in patients with HER2- and HER3-mutant cancers. Nature 554(7691):189-194, 2018. e-Pub 2018. PMID: 29420467.
Doi T, Piha-Paul SA, Jalal SI, Saraf S, Lunceford J, Koshiji M, Bennouna J. Safety and antitumor activity of the anti-programmed death-1 antibody pembrolizumab in patients with advanced esophageal carcinoma. J Clin Oncol 36(1):61-67, 2018. e-Pub 2018. PMID: 29116900.
Möhrmann L, Huang H, Hong DS, Tsimberidou AM, Fu S, Piha-Paul S, Subbiah V, Karp DD, Naing A, Krug AK, Enderle D, Priewasser T, Noerholm M, Eitan E, Coticchia C, Stoll G, Jordan LM, Eng C, Kopetz S, Skog J, Meric-Bernstam F, Janku F. Liquid biopsies using plasma exosomal nucleic acids and plasma cell-free DNA compared with clinical outcomes of patients with advanced cancers. Clin Cancer Res 24(1):181-188, 2018. e-Pub 2018. PMID: 29051321.
Groisberg R, Hong DS, Behrang A, Hess K, Janku F, Piha-Paul S, Naing A, Fu S, Benjamin R, Patel S, Somaiah N, Conley A, Meric-Bernstam F, Subbiah V. Characteristics and outcomes of patients with advanced sarcoma enrolled in early phase immunotherapy trials. J Immunother Cancer 5(1):100, 2017. e-Pub 2017. PMID: 29254498.
Frenel JS, Le Tourneau C, O'Neil B, Ott PA, Piha-Paul SA, Gomez-Roca C, van Brummelen EMJ, Rugo HS, Thomas S, Saraf S, Rangwala R, Varga A. Safety and efficacy of pembrolizumab in advanced, programmed death ligand 1-positive cervical cancer: results from the phase Ib KEYNOTE-028 trial. J Clin Oncol 35(36):4035-4041, 2017. e-Pub 2017. PMID: 29095678.
Dembla V, Groisberg R, Hess K, Fu S, Wheler J, Hong DS, Janku F, Zinner R, Piha-Paul SA, Ravi V, Benjamin RS, Patel S, Somaiah N, Herzog CE, Karp DD, Roszik J, Meric-Bernstam F, Subbiah V. Outcomes of patients with sarcoma enrolled in clinical trials of pazopanib combined with histone deacetylase, mTOR, Her2, or MEK inhibitors. Sci Rep 7(1):15963, 2017. e-Pub 2017. PMID: 29162825.
Goldstein JB, Tang C, Hess KR, Hong D, Subbiah V, Janku F, Fu S, Karp DD, Naing A, Tsimberidou AM, Wheler J, Zinner R, Javle M, Varadhachary GR, Wolff RA, Fogelman DR, Meric-Bernstam F, Piha-Paul SA. Outcomes of phase I clinical trials for patients with advanced pancreatic cancer: update of the MD Anderson Cancer Center experience. Oncotarget 8(50):87163-87173, 2017. e-Pub 2017. PMID: 29152071.
Mita M, Fu S, Piha-Paul SA, Janku F, Mita A, Natale R, Guo W, Zhao C, Kurzrock R, Naing A. Phase I trial of MEK 1/2 inhibitor pimasertib combined with mTOR inhibitor temsirolimus in patients with advanced solid tumors. Invest New Drugs 35(5):616-626, 2017. e-Pub 2017. PMID: 28194539.
Tsimberidou AM, Hong DS, Cartwright C, Wheler JJ, Falchook GS, Naing A, Fu S, Piha-Paul, Janku F, Meric Bernstam F, Hwu P, Kee B, Kies MS, Broaddus R, Mendelsohn J, Hess KR, Kurzrock R. Initiative for molecular profiling and advanced cancer therapy (IMPACT): an MD Anderson precision medicine study. JCO Precis Oncol 2017:PO.17.00002, 2017. e-Pub 2017. PMID: 29082359.
Johnson A, Khotskaya YB, Brusco L, Zeng J, Holla V, Bailey AM, Litzenburger BC, Sanchez N, Shufean MA, Piha-Paul S, Subbiah V, Hong D, Routbort M, Broaddus R, Mills Shaw KR, Mills GB, Mendelsohn J, Meric-Bernstam F. Clinical Use of Precision Oncology Decision Support. JCO Precis Oncol 1:PO.17.00036, 2017. e-Pub 2017. PMID: 30320296.
Ayers M, Lunceford J, Nebozhyn M, Murphy E, Loboda A, Kaufman DR, Albright A, Cheng JD, Kang SP, Shankaran V, Piha-Paul SA, Yearley J, Seiwert TY, Ribas A, McClanahan TK. IFN-γ-related mRNA profile predicts clinical response to PD-1 blockade. J Clin Invest 127(8):2930-2940, 2017. e-Pub 2017. PMID: 28650338.
Kehl KL, Fullmer CP, Fu S, George GC, Hess KR, Janku F, Karp DD, Kato S, Kizer CK, Kurzrock R, Naing A, Pant S, Piha-Paul SA, Subbiah V, Tsimberidou AM, Hong DS. Insurance clearance for early-phase oncology clinical trials following the affordable care act. Clin Cancer Res 23(15):4155-4162, 2017. e-Pub 2017. PMID: 28729355.
Fujii T, Barzi A, Sartore-Bianchi A, Cassingena A, Siravegna G, Karp D, Piha-Paul S, Subbiah V, Tsimberidou AM, Huang H, Veronese S, Di Nicolantonio F, Pingle SC, Vibat CR, Hancock S, Berz D, Melnikova VO, Erlander MG, Luthra R, Kopetz S, Meric-Bernstam F, Siena S, Lenz HJ, Bardelli A, Janku F. Mutation-enrichment next-generation sequencing for quantitative detection of KRAS mutations in urine cell-free DNA from patients with advanced cancers. Clin Cancer Res 23(14):3657-3666, 2017. e-Pub 2017. PMID: 28096270.
Groisberg R, Hong DS, Holla V, Janku F, Piha-Paul S, Ravi V, Benjamin R, Patel SK, Somaiah N, Conley A, Ali SM, Schrock AB, Ross JS, Stephens PJ, Miller VA, Sen S, Herzog C, Meric-Bernstam F, Subbiah V. Clinical genomic profiling to identify actionable alterations for investigational therapies in patients with diverse sarcomas. Oncotarget 8(24):39254-39267, 2017. e-Pub 2017. PMID: 28424409.
Fu S, Hirte H, Welch S, Ilenchuk TT, Lutes T, Rice C, Fields N, Nemet A, Dugourd D, Piha-Paul S, Subbiah V, Liu L, Gong J, Hong D, Stewart JM. First-in-human phase I study of SOR-C13, a TRPV6 calcium channel inhibitor, in patients with advanced solid tumors. Invest New Drugs 25(3):234-333, 2017. e-Pub 2017. PMID: 28150073.
Ott PA, Piha-Paul SA, Munster P, Pishvaian MJ, van Brummelen EM, Cohen RB, Gomez-Roca C, Ejadi S, Stein M, Chan E, Simonelli M, Morosky A, Saraf S, Emancipator K, Koshiji M, Bennouna J. Safety and antitumor activity of the anti-PD-1 antibody pembrolizumab in patients with recurrent carcinoma of the anal canal. Ann Oncol 28(5):1036-1041, 2017. e-Pub 2017. PMID: 28453692.
Wang Z, Piha-Paul S, Janku F, Subbiah V, Shi N, Gong J, Wathoo C, Shaw K, Hess K, Broaddus R, Naing A, Hong D, Tsimberidou AM, Karp D, Yao J, Meric-Bernstam F, Fu S. Antiangiogenesis and gene aberration-related therapy may improve overall survival in patients with concurrent KRAS and TP53 hotspot mutant cancer. Oncotarget 8(20):33796-33806, 2017. e-Pub 2017. PMID: 28430579.
Tolcher AW, Berlin JD, Cosaert J, Kauh J, Chan E, Piha-Paul SA, Amaya A, Tang S, Driscoll K, Kimbung R, Kambhampati SR, Gueorguieva I, Hong DS. A phase 1 study of anti-TGFβ receptor type-II monoclonal antibody LY3022859 in patients with advanced solid tumors. Cancer Chemother Pharmacol 79(4):673-680, 2017. e-Pub 2017. PMID: 28280971.
Subbiah V, Khawaja MR, Hong DS, Amini B, Yungfang J, Liu H, Johnson A, Schrock AB, Ali SM, Sun JX, Fabrizio D, Piha-Paul S, Fu S, Tsimberidou AM, Naing A, Janku F, Karp DD, Overman M, Eng C, Kopetz S, Meric-Bernstam F, Falchook GS. First-in-human trial of multikinase VEGF inhibitor regorafenib and anti-EGFR antibody cetuximab in advanced cancer patients. JCI Insight 2(8), 2017. e-Pub 2017. PMID: 28422758.
Fu S, Hirte H, Welch S, Ilenchuk TT, Lutes T, Rice C, Fields N, Nemet A, Dugourd D, Piha-Paul S, Subbiah V, Liu L, Gong J, Hong D, Stewart JM. Erratum to: First-in-human phase I study of SOR-C13, a TRPV6 calcium channel inhibitor, in patients with advanced solid tumors. Invest New Drugs 2(8):90380, 2017. e-Pub 2017. PMID: 28389981.
Janku F, Huang HJ, Fujii T, Shelton DN, Madwani K, Fu S, Tsimberidou AM, Piha-Paul SA, Wheler JJ, Zinner RG, Naing A, Hong DS, Karp DD, Cabrilo G, Kopetz ES, Subbiah V, Luthra R, Kee BK, Eng C, Morris VK, Karlin-Neumann GA, Meric-Bernstam F. Multiplex KRASG12/G13 mutation testing of unamplified cell-free DNA from the plasma of patients with advanced cancers using droplet digital polymerase chain reaction. Ann Oncol 28(3):642-650, 2017. e-Pub 2017. PMID: 27993791.
Reilley MJ, Bailey A, Subbiah V, Janku F, Naing A, Falchook G, Karp D, Piha-Paul S, Tsimberidou A, Fu S, Lim J, Bean S, Bass A, Montez S, Vence L, Sharma P, Allison J, Meric-Bernstam F, Hong DS. Phase I clinical trial of combination imatinib and ipilimumab in patients with advanced malignancies. J Immunother Cancer 5:35, 2017. e-Pub 2017. PMID: 28428884.
Kinahan H, Maiti A, Hess K, Dempsey J, Beatty L, Baldwin S, Hong DS, Naing A, Fu S, Tsimberidou AM, Piha-Paul S, Janku F, Karp D, Reddy S, Yennu S, Epner D, Bruera E, Meric-Bernstam F, Falchook G, Subbiah V. Post-discharge survival outcomes of patients with advanced cancer from The University of Texas MD Anderson Cancer Center Investigational Cancer Therapeutics (Phase I Trials) inpatient unit. Oncology 92(1):14-20, 2017. e-Pub 2017. PMID: 27802448.
O'Neil BH, Wallmark JM, Lorente D, Elez E, Raimbourg J, Gomez-Roca C, Ejadi S, Piha-Paul SA, Stein MN, Abdul Razak AR, Dotti K, Santoro A, Cohen RB, Gould M, Saraf S, Stein K, Han SW. Safety and antitumor activity of the anti-PD-1 antibody pembrolizumab in patients with advanced colorectal carcinoma. PLoS One 12(12):e0189848, 2017. e-Pub 2017. PMID: 29284010.
Hong DS, Morris VK, El Osta B, Sorokin AV, Janku F, Fu S, Overman MJ, Piha-Paul S, Subbiah V, Kee B, Tsimberidou A, Fogelman D, Bellido J, Shureiqi I, Huang H, Atkins J, Tarcic G, Sommer N, Lanman R, Meric-Bernstam F, Kopetz S. Phase 1B study of vemurafenib in combination with irinotecan and cetuximab in patients with metastatic colorectal cancer with BRAF V600E mutation. Cancer Discov 6(12):1352-1365, 2016. e-Pub 2016. PMID: 27729313.
Wang Z, Shi N, Naing A, Janku F, Subbiah V, Araujo DM, Patel SR, Ludwig JA, Ramondetta LM, Levenback CF, Ramirez PT, Piha-Paul SA, Hong D, Karp DD, Tsimberidou AM, Meric-Bernstam F, Fu S. Survival of patients with metastatic leiomyosarcoma: the MD Anderson Clinical Center for targeted therapy experience. Cancer Med 5(12):3437-3444, 2016. e-Pub 2016. PMID: 27882721.
Subbiah V, Holmes O, Gowen K, Spritz D, Amini B, Wang WL, Schrock AB, Meric-Bernstam F, Zinner R, Piha-Paul S, Zarzour M, Elvin JA, Erlich RL, Stockman DL, Vergilio JA, Suh JH, Stephens PJ, Miller V, Ross JS, Ali SM. Activity of c-Met/ALK inhibitor crizotinib and multi-kinase VEGF inhibitor pazopanib in metastatic gastrointestinal neuroectodermal tumor harboring EWSR1-CREB1 fusion. Oncology 91(6):348-353, 2016. e-Pub 2016. PMID: 27764830.
Pandey P, Al-Rohil RN, Goldstein JB, Tetzlaff MT, Barnes TG, Baldwin SE, Fogelman D, Abraham SC, Piha-Paul SA. Cutaneous metastasis of a mucoepidermoid carcinoma of the pancreas: first reported case. Am J Dermatopathol 38(11):852-856, 2016. e-Pub 2016. PMID: 27043340.
George GC, Iwuanyanwu EC, Anderson KO, Yusuf A, Zinner RG, Piha-Paul SA, Tsimberidou AM, Naing A, Fu S, Janku F, Subbiah V, Cleeland CS, Mendoza TR, Hong DS. Sleep quality and its association with fatigue, symptom burden, and mood in patients with advanced cancer in a clinic for early-phase oncology clinical trials. Cancer 122(21):3401-3409, 2016. e-Pub 2016. PMID: 27412379.
Wheler JJ, Janku F, Naing A, Li Y, Stephen B, Zinner R, Subbiah V, Fu S, Karp D, Falchook GS, Tsimberidou AM, Piha-Paul S, Anderson R, Ke D, Miller V, Yelensky R, Lee JJ, Hong D, Kurzrock R. TP53 alterations correlate with response to VEGF/VEGFR inhibitors: implications for targeted therapeutics. Mol Cancer Ther 15(10):2475-2485, 2016. e-Pub 2016. PMID: 27466356.
Park H, Garrido-Laguna I, Naing A, Fu S, Falchook GS, Piha-Paul SA, Wheler JJ, Hong DS, Tsimberidou AM, Subbiah V, Zinner RG, Kaseb AO, Patel S, Fanale MA, Velez-Bravo VM, Meric-Bernstam F, Kurzrock R, Janku F. Phase I dose-escalation study of the mTOR inhibitor sirolimus and the HDAC inhibitor vorinostat in patients with advanced malignancy. Oncotarget 7(41):67521-67531, 2016. e-Pub 2016. PMID: 27589687.
Subbiah V, Hess KR, Khawaja MR, Wagner MJ, Tang C, Naing A, Fu S, Janku F, Piha-Paul S, Tsimberidou AM, Herzog CE, Ludwig JA, Patel S, Ravi V, Benjamin RS, Meric-Bernstam F, Hong DS. Evaluation of novel targeted therapies in aggressive biology sarcoma patients after progression from US FDA approved therapies. Sci Rep 6:35448, 2016. e-Pub 2016. PMID: 27748430.
Goldstein J, Pandey P, Fleming N, Westin S, Piha-Paul S. A non-pregnant woman with elevated beta-HCG: A case of para-neoplastic syndrome in ovarian cancer. Gynecol Oncol Rep 17:49-52, 2016. e-Pub 2016. PMID: 27355002.
Hou MM, Wang Z, Janku F, Piha-Paul SA, Naing A, Hong D, Westin S, Coleman RL, Sood AK, Tsimberidou AM, Subbiah V, Wheler J, Zinner R, Lu K, Meric-Bernstam F, Fu S. Continuous anti-angiogenic therapy after tumor progression in patients with recurrent high-grade epithelial ovarian cancer: phase I trial experience. Oncotarget 7(23):35132-43, 2016. e-Pub 2016. PMID: 27147567.
Wheler JJ, Janku F, Naing A, Li Y, Stephen B, Zinner RG, Subbiah V, Fu S, Karp DD, Falchook GS, Tsimberidou AM, Piha-Paul SA, Anderson R, Ke D, Miller VA, Yelensky R, Lee JJ, Hong D, Kurzrock R. Cancer therapy directed by comprehensive genomic profiling: a single center study. Cancer Res 76(13):3690-701, 2016. e-Pub 2016. PMID: 27197177.
Janku F, Huang HJ, Claes B, Falchook GS, Fu S, Hong D, Ramzanali NM, Nitti G, Cabrilo G, Tsimberidou AM, Naing A, Piha-Paul SA, Wheler JJ, Karp DD, Holley VR, Zinner RG, Subbiah V, Luthra R, Kopetz S, Overman MJ, Kee BK, Patel S, Devogelaere B, Sablon E, Maertens G, Mills GB, Kurzrock R, Meric-Bernstam F. BRAF mutation testing in cell-free DNA from the plasma of patients with advanced cancers using a rapid, automated molecular diagnostics system. Mol Cancer Ther 15(6):1397-404, 2016. e-Pub 2016. PMID: 27207774.
Hong D, Infante J, Janku F, Jones S, Nguyen LM, Burris H, Naing A, Bauer TM, Piha-Paul S, Johnson FM, Kurzrock R, Golden L, Hynes S, Lin J, Lin AB, Bendell J. Phase I study of LY2606368, a checkpoint kinase 1 inhibitor, in patients with advanced cancer. J Clin Oncol 34(15):1764-71, 2016. e-Pub 2016. PMID: 27044938.
Said R, Kakadiaris E, Piha-Paul S, Fu S, Falchook G, Janku F, Wheler JJ, Zinner R, Hong DS, Kurzrock R, Tsimberidou AM. Phase I clinical trial of lenalidomide in combination with bevacizumab in patients with advanced cancer. Cancer Chemother Pharmacol 77(5):1097-102, 2016. e-Pub 2016. PMID: 27085994.
Khawaja MR, Nick AM, Madhusudanannair V, Fu S, Hong D, McQuinn LM, Ng CS, Piha-Paul SA, Janku F, Subbiah V, Tsimberidou A, Karp D, Meric-Bernstam F, Lu KH, Naing A. Phase I dose escalation study of temsirolimus in combination with metformin in patients with advanced/refractory cancers. Cancer Chemother Pharmacol 77(5):973-7, 2016. e-Pub 2016. PMID: 27014780.
Liu X, Kambrick S, Fu S, Naing A, Subbiah V, Blumenschein GR, Glisson BS, Kies MS, Tsimberidou AM, Wheler JJ, Zinner RG, Hong DS, Kurzrock R, Piha-Paul SA. Advanced malignancies treated with a combination of the VEGF inhibitor bevacizumab, anti-EGFR antibody cetuximab, and the mTOR inhibitor temsirolimus. Oncotarget 7(17):23227-38, 2016. e-Pub 2016. PMID: 26933802.
Said R, Ye Y, Hong DS, Naing A, Falchook G, Fu S, Wheler JJ, Piha-Paul S, Tsimberidou AM. Phase I clinical trial of lenalidomide in combination with 5-fluorouracil, leucovorin, and oxaliplatin in patients with advanced cancer. Cancer Chemother Pharmacol 77(3):575-81, 2016. e-Pub 2016. PMID: 26825327.
Gupta S, Argilés G, Munster PN, Hollebecque A, Dajani O, Cheng JD, Wang R, Swift A, Tosolini A, Piha-Paul SA. A phase I trial of combined ridaforolimus and MK-2206 in patients with advanced malignancies. Clin Cancer Res 21(23):5235-44, 2015. e-Pub 2015. PMID: 26187616.
Hong D, Kurzrock R, Kim Y, Woessner R, Younes A, Nemunaitis J, Fowler N, Zhou T, Schmidt J, Jo M, Lee SJ, Yamashita M, Hughes SG, Fayad L, Piha-Paul S, Nadella MV, Mohseni M, Lawson D, Reimer C, Blakey DC, Xiao X, Hsu J, Revenko A, Monia BP, MacLeod AR. AZD9150, a next-generation antisense oligonucleotide inhibitor of STAT3 with early evidence of clinical activity in lymphoma and lung cancer. Sci Transl Med 7(314):314ra185, 2015. e-Pub 2015. PMID: 26582900.
Meric-Bernstam F, Brusco L, Shaw K, Horombe C, Kopetz S, Davies MA, Routbort M, Piha-Paul SA, Janku F, Ueno N, Hong D, De Groot J, Ravi V, Li Y, Luthra R, Patel K, Broaddus R, Mendelsohn J, Mills GB. Feasibility of large-scale genomic testing to facilitate enrollment onto genomically matched clinical trials. J Clin Oncol 33(25):2753-62, 2015. e-Pub 2015. PMID: 26014291.
Piha-Paul SA, Munster PN, Hollebecque A, Argilés G, Dajani O, Cheng JD, Wang R, Swift A, Tosolini A, Gupta S. Results of a phase I trial combining ridaforolimus and MK-0752 in patients with advanced solid tumours. Eur J Cancer 51(14):1865-73, 2015. e-Pub 2015. PMID: 26199039.
Janku F, Angenendt P, Tsimberidou AM, Fu S, Naing A, Falchook GS, Hong DS, Holley VR, Cabrilo G, Wheler JJ, Piha-Paul SA, Zinner RG, Bedikian AY, Overman MJ, Kee BK, Kim KB, Kopetz ES, Luthra R, Diehl F, Meric-Bernstam F, Kurzrock R. Erratum: Actionable mutations in plasma cell-free DNA in patients with advanced cancers referred for experimental targeted therapies. Oncotarget 6(27):24581, 2015. e-Pub 2015. PMID: 26405159.
Subbiah IM, Falchook GS, Kaseb AO, Hess KR, Tsimberidou AM, Fu S, Subbiah V, Hong DS, Naing A, Piha-Paul SA, Akmal O, Janku F, Kurzrock R. Exploring response signals and targets in aggressive unresectable hepatocellular carcinoma: an analysis of targeted therapy phase 1 trials. Oncotarget 6(29):28453-62, 2015. e-Pub 2015. PMID: 26164085.
Henary H, George GC, Wheler J, Naing A, Piha-Paul S, Fu S, Mistry R, Zinner R, Kurzrock R, Hong DS. A phase 1 study of intermittently administered pazopanib in combination with continuous daily dosing of lapatinib in patients with solid tumors. Cancer Chemother Pharmacol 76(3):597-603, 2015. e-Pub 2015. PMID: 26210681.
Janku F, Claes B, Huang HJ, Falchook GS, Devogelaere B, Kockx M, Bempt IV, Reijans M, Naing A, Fu S, Piha-Paul SA, Hong DS, Holley VR, Tsimberidou AM, Stepanek VM, Patel SP, Kopetz ES, Subbiah V, Wheler JJ, Zinner RG, Karp DD, Luthra R, Roy-Chowdhuri S, Sablon E, Meric-Bernstam F, Maertens G, Kurzrock R. BRAF mutation testing with a rapid, fully integrated molecular diagnostics system. Oncotarget 6(29):26886-94, 2015. e-Pub 2015. PMID: 26330075.
Boland GM, Piha-Paul SA, Subbiah V, Routbort M, Herbrich SM, Baggerly K, Patel KP, Brusco L, Horombe C, Naing A, Fu S, Hong DS, Janku F, Johnson A, Broaddus R, Luthra R, Shaw K, Mendelsohn J, Mills GB, Meric-Bernstam F. Clinical next generation sequencing to identify actionable aberrations in a phase I program. Oncotarget 6(24):20099-110, 2015. e-Pub 2015. PMID: 26015395.
Said R, Kurzrock R, Naing A, Hong DS, Fu S, Piha-Paul SA, Wheler JJ, Janku F, Kee BK, Bidyasar S, Lim J, Wallace M, Tsimberidou AM. Dose-finding study of hepatic arterial infusion of irinotecan-based treatment in patients with advanced cancers metastatic to the liver. Invest New Drugs 33(4):911-20, 2015. e-Pub 2015. PMID: 25990659.
Meric-Bernstam F, Johnson A, Holla V, Bailey AM, Brusco L, Chen K, Routbort M, Patel KP, Zeng J, Kopetz S, Davies MA, Piha-Paul SA, Hong DS, Eterovic AK, Tsimberidou AM, Broaddus R, Bernstam EV, Shaw KR, Mendelsohn J, Mills GB. A decision support framework for genomically informed investigational cancer therapy. J Natl Cancer Inst 107(7), 2015. e-Pub 2015. PMID: 25863335.
Rodrigues HV, Ke D, Lim J, Stephen B, Bellido J, Janku F, Zinner R, Tsimberidou A, Hong D, Piha-Paul S, Fu S, Naing A, Subbiah V, Karp D, Falchook G, Kurzrock R, Wheler J. Phase I combination of pazopanib and everolimus in PIK3CA mutation positive/PTEN loss patients with advanced solid tumors refractory to standard therapy. Invest New Drugs 33(3):700-9, 2015. e-Pub 2015. PMID: 25902899.
Hong DS, Janku F, Naing A, Falchook GS, Piha-Paul S, Wheler JJ, Fu S, Tsimberidou AM, Stecher M, Mohanty P, Simard J, Kurzrock R. Xilonix, a novel true human antibody targeting the inflammatory cytokine interleukin-1 alpha, in non-small cell lung cancer. Invest New Drugs 33(3):621-31, 2015. e-Pub 2015. PMID: 25822109.
Fu S, Hou MM, Naing A, Janku F, Hess K, Zinner R, Subbiah V, Hong D, Wheler J, Piha-Paul S, Tsimberidou A, Karp D, Araujo D, Kee B, Hwu P, Wolff R, Kurzrock R, Meric-Bernstam F. Phase I study of pazopanib and vorinostat: a therapeutic approach for inhibiting mutant p53-mediated angiogenesis and facilitating mutant p53 degradation. Ann Oncol 26(5):1012-8, 2015. e-Pub 2015. PMID: 25669829.
Janku F, Angenendt P, Tsimberidou AM, Fu S, Naing A, Falchook GS, Hong DS, Holley VR, Cabrilo G, Wheler JJ, Piha-Paul SA, Zinner RG, Bedikian AY, Overman MJ, Kee BK, Kim KB, Kopetz ES, Luthra R, Diehl F, Meric-Bernstam F, Kurzrock R. Actionable mutations in plasma cell-free DNA in patients with advanced cancers referred for experimental targeted therapies. Oncotarget 6(14):12809-21, 2015. e-Pub 2015. PMID: 25980577.
Gonzalez-Angulo AM, Krop I, Akcakanat A, Chen H, Liu S, Li Y, Culotta KS, Tarco E, Piha-Paul S, Moulder-Thompson S, Velez-Bravo V, Sahin AA, Doyle LA, Do KA, Winer EP, Mills GB, Kurzrock R, Meric-Bernstam F. SU2C Phase Ib study of paclitaxel and MK-2206 in advanced solid tumors and metastatic breast cancer. J Natl Cancer Inst 107(3), 2015. e-Pub 2015. PMID: 25688104.
Falchook GS, Moulder S, Naing A, Wheler JJ, Hong DS, Piha-Paul SA, Tsimberidou AM, Fu S, Zinner R, Janku F, Jiang Y, Huang M, Parkhurst KL, Kurzrock R. A phase I trial of combination trastuzumab, lapatinib, and bevacizumab in patients with advanced cancer. Invest New Drugs 33(1):177-86, 2015. e-Pub 2015. PMID: 25323060.
Jardim DL, de Melo Gagliato D, Falchook G, Zinner R, Wheler JJ, Janku F, Subbiah V, Piha-Paul SA, Fu S, Tannir N, Corn P, Tang C, Hess K, Roy-Chowdhuri S, Kurzrock R, Meric-Bernstam F, Hong DS. MET abnormalities in patients with genitourinary malignancies and outcomes with c-MET inhibitors. Clin Genitourin Cancer 13(1):e19-26, 2015. e-Pub 2015. PMID: 25087088.
Falchook GS, Wheler JJ, Naing A, Piha-Paul SA, Fu S, Tsimberidou AM, Hong DS, Janku F, Zinner R, Jiang Y, Huang M, Lin Q, Parkhurst K, Kurzrock R. Dual antiangiogenic inhibition: a phase I dose escalation and expansion trial targeting VEGF-A and VEGFR in patients with advanced solid tumors. Invest New Drugs 33(1):215-24, 2015. e-Pub 2015. PMID: 25363205.
Falchook GS, Millward M, Hong D, Naing A, Piha-Paul S, Waguespack SG, Cabanillas ME, Sherman SI, Ma B, Curtis M, Goodman V, Kurzrock R. BRAF inhibitor dabrafenib in patients with metastatic BRAF-mutant thyroid cancer. Thyroid 25(1):71-7, 2015. e-Pub 2015. PMID: 25285888.
Tsimberidou AM, Said R, Culotta K, Wistuba I, Jelinek J, Fu S, Falchook G, Naing A, Piha-Paul S, Zinner R, Siddik ZH, He G, Hess K, Stewart DJ, Kurzrock R, Issa JP. Phase I study of azacitidine and oxaliplatin in patients with advanced cancers that have relapsed or are refractory to any platinum therapy. Clin Epigenetics 7(1):29, 2015. e-Pub 2015. PMID: 25806091.
Liu X, George GC, Tsimberidou AM, Naing A, Wheler JJ, Kopetz S, Fu S, Piha-Paul SA, Eng C, Falchook GS, Janku F, Garrett C, Karp D, Kurzrock R, Zinner R, Raghav K, Subbiah V, Hess K, Meric-Bernstam F, Hong DS, Overman MJ. Retreatment with anti-EGFR based therapies in metastatic colorectal cancer: impact of intervening time interval and prior anti-EGFR response. BMC Cancer 15(1):713, 2015. e-Pub 2015. PMID: 26474549.
Fu S, Shi N, Wheler J, Naing A, Janku F, Piha-Paul SA, Gong J, Hong D, Tsimberidou A, Zinner R, Subbiah V, Hou MM, Ramirez P, Ramondetta L, Lu K, Meric-Bernstam F. Characteristics and outcomes for patients with advanced vaginal or vulvar cancer referred to a phase I clinical trials program: the MD Anderson cancer center experience. Gynecol Oncol Res Pract 2:10, 2015. e-Pub 2015. PMID: 27231570.
Goldstein J, Patel AB, Curry JL, Subbiah V, Piha-Paul S. Photoallergic reaction in a patient receiving vandetanib for metastatic follicular thyroid carcinoma: a case report. BMC Dermatol 15(2), 2015. e-Pub 2015. PMID: 25886034.
de Melo Gagliato D, Jardim DL, Falchook G, Tang C, Zinner R, Wheler JJ, Janku F, Subbiah V, Piha-Paul SA, Fu S, Hess K, Roy-Chowdhuri S, Moulder S, Gonzalez-Angulo AM, Meric-Bernstam F, Hong DS. Analysis of MET genetic aberrations in patients with breast cancer at MD Anderson Phase I Unit. Clin Breast Cancer 14(6):468-74, 2014. e-Pub 2014. PMID: 25065564.
Tang C, Hess K, Jardim DL, Gagliato Dde M, Tsimberidou AM, Falchook G, Fu S, Janku F, Naing A, Piha-Paul S, Subbiah V, Wheler J, Zinner RG, Kurzrock R, Ellis LM, Meric-Bernstam F, Hong DS. Synergy between VEGF/VEGFR inhibitors and chemotherapy agents in the phase I clinic. Clin Cancer Res 20(23):5956-63, 2014. e-Pub 2014. PMID: 25316815.
Said R, Ye Y, Falchook GS, Janku F, Naing A, Zinner R, Blumenschein GR, Fu S, Hong DS, Piha-Paul SA, Wheler JJ, Kurzrock R, Palmer GA, Aldape K, Hess KR, Tsimberidou AM. Outcomes of patients with advanced cancer and KRAS mutations in phase I clinical trials. Oncotarget 5(19):8937-46, 2014. e-Pub 2014. PMID: 25313136.
Tsimberidou AM, Wen S, Hong DS, Wheler JJ, Falchook GS, Fu S, Piha-Paul S, Naing A, Janku F, Aldape K, Ye Y, Kurzrock R, Berry D. Personalized medicine for patients with advanced cancer in the phase I program at MD Anderson: validation and landmark analyses. Clin Cancer Res 20(18):4827-36, 2014. e-Pub 2014. PMID: 24987059.
Corrales-Medina FF, Herzog C, Hess K, Egas-Bejar D, Hong DS, Falchook G, Anderson P, Nunez C, Huh WW, Naing A, Tsimberidou AM, Wheler J, Piha-Paul SA, Janku F, Kleinerman ES, Kurzrock R, Subbiah V. Clinical characteristics and outcomes of pediatric oncology patients with aggressive biology enrolled in phase I clinical trials designed for adults: The University of Texas MD Anderson Cancer Center experience. Oncoscience 1(7):522-530, 2014. e-Pub 2014. PMID: 25587555.
Hong DS, Garrido-Laguna I, Ekmekcioglu S, Falchook GS, Naing A, Wheler JJ, Fu S, Moulder SL, Piha-Paul S, Tsimberidou AM, Wen Y, Culotta KS, Anderes K, Davis DW, Liu W, George GC, Camacho LH, Percy Ivy S, Kurzrock R. Dual inhibition of the vascular endothelial growth factor pathway: A phase 1 trial evaluating bevacizumab and AZD2171 (cediranib) in patients with advanced solid tumors. Cancer 120(14):2164-73, 2014. e-Pub 2014. PMID: 24752867.
Fu S, Hou MM, Wheler J, Hong D, Naing A, Tsimberidou A, Janku F, Zinner R, Piha-Paul S, Falchook G, Kuo MT, Kurzrock R. Exploratory study of carboplatin plus the copper-lowering agent trientine in patients with advanced malignancies. Invest New Drugs 32(3):465-72, 2014. e-Pub 2014. PMID: 24306314.
Hou MM, Liu X, Wheler J, Naing A, Hong D, Bodurka D, Schmeler K, Tsimberidou A, Janku F, Zinner R, Piha-Paul S, Hu CY, Lu K, Kurzrock R, Fu S. Outcomes of patients with metastatic cervical cancer in a phase I clinical trials program. Anticancer Res 34(5):2349-55, 2014. e-Pub 2014. PMID: 24778042.
Wheler JJ, Moulder SL, Naing A, Janku F, Piha-Paul SA, Falchook GS, Zinner R, Tsimberidou AM, Fu S, Hong DS, Atkins JT, Yelensky R, Stephens PJ, Kurzrock R. Anastrozole and everolimus in advanced gynecologic and breast malignancies: activity and molecular alterations in the PI3K/AKT/mTOR pathway. Oncotarget 5(10):3029-38, 2014. e-Pub 2014. PMID: 24912489.
Hong DS, Hui D, Bruera E, Janku F, Naing A, Falchook GS, Piha-Paul S, Wheler JJ, Fu S, Tsimberidou AM, Stecher M, Mohanty P, Simard J, Kurzrock R. MABp1, a first-in-class true human antibody targeting interleukin-1α in refractory cancers: an open-label, phase 1 dose-escalation and expansion study. Lancet Oncol 15(6):656-66, 2014. e-Pub 2014. PMID: 24746841.
Piha-Paul SA, Shin SJ, Vats T, Guha-Thakurta N, Aaron J, Rytting M, Kleinerman E, Kurzrock R. Pediatric patients with refractory central nervous system tumors: experiences of a clinical trial combining bevacizumab and temsirolimus. Anticancer Res 34(4):1939-45, 2014. e-Pub 2014. PMID: 24692729.
Piha-Paul SA, Wheler JJ, Fu S, Levenback C, Lu K, Falchook GS, Naing A, Hong DS, Tsimberidou AM, Kurzrock R. Advanced gynecologic malignancies treated with a combination of the VEGF inhibitor bevacizumab and the mTOR inhibitor temsirolimus. Oncotarget 5(7):1846-55, 2014. e-Pub 2014. PMID: 24742900.
Jardim DL, de Melo Gagliato D, Falchook GS, Janku F, Zinner R, Wheler JJ, Subbiah V, Piha-Paul SA, Fu S, Murphy MB, Ajani J, Tang C, Hess K, Hamilton SR, Roy-Chowdhuri S, Kurzrock R, Meric-Bernstam F, Hong DS. MET aberrations and c-MET inhibitors in patients with gastric and esophageal cancers in a phase I unit. Oncotarget 5(7):1837-45, 2014. e-Pub 2014. PMID: 24742823.
Ganesan P, Piha-Paul S, Naing A, Falchook G, Wheler J, Fu S, Hong DS, Kurzrock R, Janku F, Laday S, Bedikian AY, Kies M, Wolff RA, Tsimberidou AM. Phase I clinical trial of lenalidomide in combination with sorafenib in patients with advanced cancer. Invest New Drugs 32(2):279-86, 2014. e-Pub 2014. PMID: 23756764.
Wheler JJ, Janku F, Falchook GS, Jackson TL, Fu S, Naing A, Tsimberidou AM, Moulder SL, Hong DS, Yang H, Piha-Paul SA, Atkins JT, Garcia-Manero G, Kurzrock R. Phase I study of anti-VEGF monoclonal antibody bevacizumab and histone deacetylase inhibitor valproic acid in patients with advanced cancers. Cancer Chemother Pharmacol 73(3):495-501, 2014. e-Pub 2014. PMID: 24435060.
Tsimberidou AM, Adamopoulos AM, Ye Y, Piha-Paul S, Janku F, Fu S, Hong D, Falchook GS, Naing A, Wheler J, Fortier A, Kurzrock R, Hess KR. Phase I clinical trial of bendamustine and bevacizumab for patients with advanced cancer. J Natl Compr Canc Netw 12(2):194-203, 2014. e-Pub 2014. PMID: 24586081.
Said R, Banchs J, Wheler J, Hess KR, Falchook G, Fu S, Naing A, Hong D, Piha-Paul S, Ye Y, Yeh E, Wolff RA, Tsimberidou AM. The prognostic significance of left ventricular ejection fraction in patients with advanced cancer treated in phase I clinical trials. Ann Oncol 25(1):276-82, 2014. e-Pub 2014. PMID: 24356639.
Janku F, Hong DS, Fu S, Piha-Paul SA, Naing A, Falchook GS, Tsimberidou AM, Stepanek VM, Moulder SL, Lee JJ, Luthra R, Zinner RG, Broaddus RR, Wheler JJ, Kurzrock R. Assessing PIK3CA and PTEN in early-phase trials with PI3K/AKT/mTOR inhibitors. Cell Rep 6(2):377-87, 2014. e-Pub 2014. PMID: 24440717.
Rolfo C, Fanale D, Hong DS, Tsimberidou AM, Piha-Paul SA, Pauwels P, Van Meerbeeck JP, Caruso S, Bazan V, Cicero G, Russo A, Giovannetti E. Impact of microRNAs in resistance to chemotherapy and novel targeted agents in non-small cell lung cancer. Curr Pharm Biotechnol 15(5):475-85, 2014. e-Pub 2014. PMID: 24846062.
Falchook GS, Naing A, Wheler JJ, Tsimberidou AM, Zinner R, Hong DS, Fu S, Piha-Paul SA, Janku F, Hess KR, Bastida C, Kurzrock R. Dual EGFR inhibition in combination with anti-VEGF treatment in colorectal cancer. Oncoscience 1(8):540-9, 2014. e-Pub 2014. PMID: 25594061.
Jardim DL, Wheler JJ, Hess K, Tsimberidou AM, Zinner R, Janku F, Subbiah V, Naing A, Piha-Paul SA, Westin SN, Roy-Chowdhuri S, Meric-Bernstam F, Hong DS. FBXW7 mutations in patients with advanced cancers: clinical and molecular characteristics and outcomes with mTOR inhibitors. PLoS One 9(2):e89388, 2014. e-Pub 2014. PMID: 24586741.
Ganesan P, Piha-Paul S, Naing A, Falchook G, Wheler J, Janku F, Zinner R, Laday S, Kies M, Tsimberidou AM. Phase I clinical trial of lenalidomide in combination with temsirolimus in patients with advanced cancer. Invest New Drugs 31(6):1505-13, 2013. e-Pub 2013. PMID: 23982248.
Ganesan P, Janku F, Naing A, Hong DS, Tsimberidou AM, Falchook GS, Wheler JJ, Piha-Paul SA, Fu S, Stepanek VM, Lee JJ, Luthra R, Overman MJ, Kopetz ES, Wolff RA, Kurzrock R. Target-based therapeutic matching in early-phase clinical trials in patients with advanced colorectal cancer and PIK3CA mutations. Mol Cancer Ther 12(12):2857-63, 2013. e-Pub 2013. PMID: 24092809.
Wheler JJ, Tsimberidou AM, Falchook GS, Zinner RG, Hong DS, Fok JY, Fu S, Piha-Paul SA, Naing A, Kurzrock R. Combining erlotinib and cetuximab is associated with activity in patients with non small cell lung cancer (including squamous cell carcinomas) and wild-type EGFR or resistant mutations. Mol Cancer Ther 12(10):2167-75, 2013. e-Pub 2013. PMID: 23963360.
Veasey Rodrigues H, Baracos VE, Wheler JJ, Parsons HA, Hong DS, Naing A, Fu S, Falchoock G, Tsimberidou AM, Piha-Paul S, Chisholm G, Kurzrock R. Body composition and survival in the early clinical trials setting. Eur J Cancer 49(15):3068-75, 2013. e-Pub 2013. PMID: 23867127.
Hong DS, Choe JH, Naing A, Wheler JJ, Falchook GS, Piha-Paul S, Moulder SL, George GC, Choe JM, Strauss LC, Gallick GE, Kurzrock R. A phase 1 study of gemcitabine combined with dasatinib in patients with advanced solid tumors. Invest New Drugs 31(4):918-26, 2013. e-Pub 2013. PMID: 23179336.
Henary H, Hong DS, Falchook GS, Tsimberidou A, George GC, Wen S, Wheler J, Fu S, Naing A, Piha-Paul S, Janku F, Kim KB, Hwu P, Kurzrock R. Melanoma patients in a phase I clinic: molecular aberrations, targeted therapy and outcomes. Ann Oncol 24(8):2158-65, 2013. e-Pub 2013. PMID: 23576709.
Hong DS, George GC, Iwuanyanwu EC, Tavana B, Falchook GS, Piha-Paul SA, Wheler JJ, Mistry RH, Lei X, Kurzrock R. Factors related to biopsy willingness in patients with advanced cancer in a phase 1 clinic for molecularly targeted therapy. J Cancer Res Clin Oncol 139(6):963-70, 2013. e-Pub 2013. PMID: 23455881.
Wheler J, Falchook G, Tsimberidou AM, Hong D, Naing A, Piha-Paul S, Chen SS, Heymach J, Fu S, Stephen B, Fok JY, Janku F, Kurzrock R. Revisiting clinical trials using EGFR inhibitor-based regimens in patients with advanced non-small cell lung cancer: A retrospective analysis of an MD Anderson Cancer Center phase I population. Oncotarget 4(5):772-784, 2013. e-Pub 2013. PMID: 23800712.
Said R, Hong DS, Warneke CL, Lee JJ, Wheler JJ, Janku F, Naing A, Falchook GS, Fu S, Piha-Paul S, Tsimberidou AM, Kurzrock R. P53 mutations in advanced cancers: clinical characteristics, outcomes, and correlation between progression-free survival and bevacizumab-containing therapy. Oncotarget 4(5):705-14, 2013. e-Pub 2013. PMID: 23670029.
Wheler JJ, Falchook GS, Tsimberidou AM, Hong DS, Naing A, Piha-Paul SA, Chen SS, Fu S, Stephen B, Fok JY, Janku F, Kurzrock R. Aberrations in the epidermal growth factor receptor gene in 958 patients with diverse advanced tumors: implications for therapy. Ann Oncol 24(3):838-42, 2013. e-Pub 2013. PMID: 23139256.
Holsinger FC, Piha-Paul SA, Janku F, Hong DS, Atkins JT, Tsimberidou AM, Kurzrock R. Biomarker-directed therapy of squamous carcinomas of the head and neck: targeting PI3K/PTEN/mTOR pathway. J Clin Oncol 31(9):e137-40, 2013. e-Pub 2013. PMID: 23358976.
Tsimberidou AM, Leick MB, Lim J, Fu S, Wheler J, Piha-Paul SA, Hong D, Falchook GS, Naing A, Subbiah IM, Fortier A, Avritscher R, Kurzrock R. Dose-finding study of hepatic arterial infusion of oxaliplatin-based treatment in patients with advanced solid tumors metastatic to the liver. Cancer Chemother Pharmacol 71(2):389-97, 2013. e-Pub 2013. PMID: 23143207.
LoRusso PM, Piha-Paul SA, Mita M, Colevas AD, Malhi V, Colburn D, Yin M, Low JA, Graham RA. Co-administration of vismodegib with rosiglitazone or combined oral contraceptive in patients with locally advanced or metastatic solid tumors: a pharmacokinetic assessment of drug-drug interaction potential. Cancer Chemother Pharmacol 71(1):193-202, 2013. e-Pub 2013. PMID: 23064958.
Janku F, Wheler JJ, Naing A, Falchook GS, Hong DS, Stepanek VM, Fu S, Piha-Paul SA, Lee JJ, Luthra R, Tsimberidou AM, Kurzrock R. PIK3CA mutation H1047R is associated with response to PI3K/AKT/mTOR signaling pathway inhibitors in early phase clinical trials. Cancer Res 73(1):276-84, 2013. e-Pub 2013. PMID: 23066039.
Subbiah IM, Subbiah V, Tsimberidou AM, Naing A, Kaseb AO, Javle M, Fu S, Hong DS, Piha-Paul S, Wheler JJ, Hess KR, Janku F, Falchook GS, Wolff RA, Kurzrock R. Targeted therapy of advanced gallbladder cancer and cholangiocarcinoma with aggressive biology: eliciting early response signals from phase I trials. Oncotarget 4(1):153-62, 2013. e-Pub 2013. PMID: 23391555.
Falchook GS, Naing A, Hong DS, Zinner R, Fu S, Piha-Paul SA, Tsimberidou AM, Morgan-Linnell SK, Jiang Y, Bastida C, Wheler JJ, Kurzrock R. Dual EGFR inhibition in combination with anti-VEGF treatment: A phase I clinical trial in non-small cell lung cancer. Oncotarget 4(1):118-27, 2013. e-Pub 2013. PMID: 23435217.
Fu S, McQuinn L, Naing A, Wheler JJ, Janku F, Falchook GS, Piha-Paul SA, Tu D, Howard A, Tsimberidou A, Zinner R, Hong DS, Kurzrock R. Barriers to study enrollment in patients with advanced cancer referred to a phase I clinical trials unit. Oncologist 18(12):1315-20, 2013. e-Pub 2013. PMID: 24153239.
Janku F, Wheler JJ, Naing A, Stepanek VM, Falchook GS, Fu S, Garrido-Laguna I, Tsimberidou AM, Piha-Paul SA, Moulder SL, Lee JJ, Luthra R, Hong DS, Kurzrock R. PIK3CA mutations in advanced cancers: characteristics and outcomes. Oncotarget 3(12):1566-75, 2012. e-Pub 2012. PMID: 23248156.
Tsimberidou AM, Iskander NG, Hong DS, Wheler JJ, Falchook GS, Fu S, Piha-Paul S, Naing A, Janku F, Luthra R, Ye Y, Wen S, Berry D, Kurzrock R. Personalized medicine in a phase I clinical trials program: The MD Anderson Cancer Center initiative. Clin Cancer Res 18(22):6373-83, 2012. e-Pub 2012. PMID: 22966018.
Cohen PR, Prieto VG, Piha-Paul SA, Kurzrock R. The "shield sign" in two men with metastatic salivary duct carcinoma to the skin: cutaneous metastases presenting as carcinoma hemorrhagiectoides. J Clin Aesthet Dermatol 5(9):27-36, 2012. e-Pub 2012. PMID: 23050032.
Fu S, Barber FD, Naing A, Wheler J, Hong D, Falchook G, Piha-Paul S, Tsimberidou A, Howard A, Kurzrock R. Advance care planning in patients with cancer referred to a phase I clinical trials program: The MD Anderson Cancer Center experience. J Clin Oncol 30(23):2891-6, 2012. e-Pub 2012. PMID: 22778314.
Wheler J, Tsimberidou AM, Hong D, Naing A, Falchook G, Piha-Paul S, Fu S, Moulder S, Stephen B, Wen S, Kurzrock R. Survival of 1,181 patients in a phase I clinic: The MD Anderson Clinical Center for Targeted Therapy experience. Clin Cancer Res 18(10):2922-9, 2012. e-Pub 2012. PMID: 22452943.
Piha-Paul SA, Cohen PR, Kurzrock R. Salivary duct carcinoma: targeting the phosphatidylinositol 3-kinase pathway by blocking Mammalian target of rapamycin with temsirolimus. J Clin Oncol 29(26):e727-30, 2011. e-Pub 2011. PMID: 21844496.
Piha-Paul SA, Hong DS, Kurzrock R. Response of lymphangioleiomyomatosis to a mammalian target of rapamycin inhibitor (temsirolimus) - based treatment. J Clin Oncol 29(12):e333-5, 2011. e-Pub 2011. PMID: 21263090.
Janku F, Tsimberidou AM, Garrido-Laguna I, Wang X, Luthra R, Hong DS, Naing A, Falchook GS, Moroney JW, Piha-Paul SA, Wheler JJ, Moulder SL, Fu S, Kurzrock R. PIK3CA mutations in patients with advanced cancers treated with PI3K/AKT/mTOR axis inhibitor. Mol Cancer Ther 10(3):558-65, 2011. e-Pub 2011. PMID: 21216929.

Review Articles

Torrado, C, Nassif, EF, Somaiah, N, Msaouel, P, Lazar, A, Piha-Paul, SA. Advancing Understanding and Therapeutic Strategies for NUT Sarcomas. Journal of Immunotherapy and Precision Oncology 8(2):113-120, 2025. e-Pub 2025. PMID: 40070529.
Nelson, BE, Naing, A, Fu, S, Sheth, RA, Murthy, R, Piha-Paul, SA. Potentiating intratumoral therapy with immune checkpoint inhibitors: shifting the paradigm of multimodality therapeutics. Immuno-Oncology and Technology 25, 2025. e-Pub 2025. PMID: 39981134.

Abstracts

Wu T, Teymur A, Derbala MH, Stephen B, Castillo L, Yang Y, Gurses SA, Tan HN, Dumbrava EE, Tsimberidou AM, Champiat S, Hajjar J, Tang T-Y, Yap TA, Rodon Ahnert J, Piha-Paul SA, Fu S, Hong DS, Meric-Bernstam F, Naing A. Immune Complex Profiling Identifies Biomarkers of Response to Immune Checkpoint Inhibitors Across Cancers. ESMO Immuno-Oncology Congress 28(Suppl), 2025. e-Pub 2025.
Braganca Xavier C, Stephen B, Gurses S, Gocio M, Kaseb M, Yang Y, Cimo A, Derbala M, Tang T-Y, Champiat S, Pohlmann P, Gouda M, Tan H, Torrado Martin C, Rodon J, Yap T, Dumbrava E, Piha-Paul S, Tsimberidou AM, Fu S, Hong D, Meric-Bernstam F, Naing A. A phase 1 dose escalation and dose expansion trial of NP-101 in patients with advanced solid tumors. SITC 2025 13(Suppl 2), 2025. e-Pub 2025.
Hanna G, Johnson F, Zandberg D, Rabinowits G, Choudhury N, Vu P, Sun L, Cote G, Wirth L, Spira A, Chawla S, Ramirez-Marquez M, Unadkat D, Mann M, Qing X, Wang H, Piha-Paul S. A Phase 1/2 study of a first-in-class non-cellular antibody-drug conjugate, micvotabart pelidotin (micvo), in combination with pembrolizumab in advanced head & neck squamous cell carcinoma (HNSCC). SITC 2025 13(Suppl 2), 2025. e-Pub 2025.
Whelan S, Williams A, Plummer R, Evans TRJ, Pacey S, Piha-Paul S, Duska L, Carter L, Weiss J, Munster P, Richardson D, El-KhoueiryA, Szmulewitz R, Liao J, De Bono J, Neuman L, Wu JQ, Lee E, Mani M, Chan E, Kom J, Schwab A, Cherala G, Sharp A. Translational Insights from a First-in-Human Study of NX-1607, an Oral CBL-B Inhibitor, in Advanced Solid Tumors. SITC 2025 13(Suppl 2), 2025. e-Pub 2025.
George G, Piha-Paul SA, Rodon Ahnert J, Dumbrava EE, Tsimberidou AM, Appleton G, Yap TA, Meric-Bernstam F, Hong DS. Dietary links with symptoms in early-phase immune checkpoint combinations trials. 2025 ASCO Quality Care Symposium 21(#10 Suppl), 2025. e-Pub 2025.
Adesoye T, Elders ML, Le H, Hong D, Belay SY, Rodon JA, Dumbrava EE, Naing A, Piha-Paul SA, Fu S, Tang T-Y, Tsimberidou AM, Tam AL, Murthy R, McNeill LH, Meric-Bernstam F. Research biopsy participation and safety in cancer therapeutic trials. AAR-NCI-EORTC 2025, 2025. e-Pub 2025.
Uzunparmak B, Su F, Johnson AM, Shaw KR, Kong EK, Korkut A, Braganca-Xavier C, Yuan Y, Fowler N, Paradiso F, Kontselidze L, Butusova A, Bagaev A, Dumbrava EE, Rodon-Ahnert J, Hong DS, Fu S, Yap TA, Naing A, Piha-Paul SA, Ferrarotto R, Iorgulescu B, Kulkarni S, Patel KP, Meric-Bernstam F. Clinical Utility of Comprehensive Genomic and Transcriptomic Analysis to Guide Therapy for Patients with Metastatic Solid Tumors. AAR-NCI-EORTC 2025 24(10_Suppl), 2025. e-Pub 2025.
Gouda MA, King L, Tang T-Y, Dumbrava EE, Champiat S, Piha-Paul SA, Pohlmann PR, Naing A, Fu S, Tsimberidou AM, Rodon J, Yap TA, Meric-Bernstam F, Hong DS. Discrepancies Between Calculated and Actual Creatinine Clearance: A Phase 1 Trial Unit Experience. AAR-NCI-EORTC 2025 24(10_Suppl), 2025. e-Pub 2025.
Fu S, Braganca Xavier C, Keyomarsi K, Wang Y, Ferry-Galow K, Wilsker D, Paradiso F, Kushnarev V, Yuan Y, Previs RA, Elias AD, Carvajal R, George TJ, Yao S, Yuan Y, Dumbrava EI, Piha-Paul SA, Tsimberidou AM, Rodon Ahnert J, Westin S, Meric-Bernstam F. Biomarker analyses of WEE1 inhibition in patients with refractory CCNE1 amplified solid tumors. AAR-NCI-EORTC 2025 24(10_Suppl), 2025. e-Pub 2025.
Tan HN, Yap TA, Rodon J, Stephan B, Dumbrava EE, Piha-Paul S, Fu S, Champiat S, Akhave N, Gillison M, Heymach JV, Hong D, Meric-Bernstam, Naing A. Clinical Outcomes and Biomarker Correlates of Patients with Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma Treated with Novel Immunotherapies in Phase 1 Trials. AAR-NCI-EORTC 2025 24(10_Suppl), 2025. e-Pub 2025.
Venturini J, Baysal M, Chakraborty A, Fu S, Hong DS, Piha-Paul SA, Naing A, Rodon J, Yap TA, Dumbrava EE, Beck J, Liu Y, Zhang J, Futreal A, Meric-Bernstam F, Tsimberidou AM. MD Anderson IMPACT2 study: Mutation enrichment analysis by tumor type and gene co-occurrence patterns in patients with DDR and non-DDR alterations. ESMO Congress 2025 36(Suppl 2), 2025. e-Pub 2025.
Schmidt S, Baysal M, Fu S, Hong DS, Piha-Paul SA, Naing A, Rodon J, Yap TA, Dumbrava EE, Beck J, Meric-Bernstam F, Tsimberidou AM. Concordance analysis of DNA and RNA profiling: Results of the MD Anderson IMPACT2 study in precision oncology. ESMO Congress 2025 36(Suppl 2), 2025. e-Pub 2025.
Moreno Garcia V, Calvo E, Villaruz L, Felip E, Bahleda R, Manley C, Garcia Lorenzo E, Yarza R, Soto-Castillo JJ, Hasan A, Billiard J, Da Silva J, Chen A, Steinbach D, Weber S, Rafeq S, Bandekar R, Bates S, Knoblauch RE, Piha-Paul S. Phase I study of intratumoral administration of JNJ-87704916, an oncolytic virus, as monotherapy and in combination with cetrelimab in advanced solid tumors. ESMO Congress 2025 36(Suppl 2), 2025. e-Pub 2025.
Piha-Paul S, Spira AI, Choudhury N, Chawla SP, Cote GM, Wirth LJ, Sun L, Ramirez M, Unadkat D, Mann M, He S, Crochiere M, Bogg O, Qing X, Wang H, Hanna GJ. A phase I/II study of a first-in-class non-cellular antibody-drug conjugate, micvotabart pelidotin (MICVO), in combination with pembrolizumab in select advanced solid tumors. ESMO Congress 2025 36(Suppl 2), 2025. e-Pub 2025.
Anja W, Sharp A, Evans TRJ, Pacey S, Piha-Paul SA, Duska LR, Carter L, Weiss J, Munster P, Richardson DL, El-Khoueiry AB, Szmulewitz R, Liao J, De Bono JS, Neuman L, Jameson K, Whelan S, Schwab A, Cherala G, Plummer R. First-in-class CBL-B inhibitor NX-1607: Phase Ia data in patients with advanced solid tumors. ESMO Congress 2025 36(Suppl 2), 2025. e-Pub 2025.
Sehgal K, Corral Jaime J, Powell SF, Perez CA, Fontana E, Kinglsey E, Longo Munoz F, Piha-Paul SA, Sanborn RE, Hyman J, Toffalorio F, Wang T, Chafin W, Peters S. Sigvotatug vedotin (SV), an investigational integrin beta-6 (IB6)–directed antibody‒drug conjugate (ADC), and pembrolizumab combination therapy: Initial results from an ongoing phase 1 study (SGNB6A-001). 2025 ASCO Annual Meeting 43(16_Suppl), 2025. e-Pub 2025.
Su F, Uzunparmak B, Johnson A, Shaw KR, Fowler NH, Kontselidze L, Bagaev A, Butusova A, Dumbrava EE, Rodon Ahnert J, Fu S, Hong DS, Yap TA, Naing A, Piha-Paul SA, Ferrarotto R, Iorgulescu B, Kulkarni S, Patel K, Meric-Bernstam F. Clinical utility of comprehensive transcriptome testing in advanced solid tumors. 2025 ASCO Annual Meeting, 2025. e-Pub 2025.
Piha-Paul SA, Yamamoto N, Kuboki Y, Safran H, Ajari I, Takahashi S, Sekiya M, Sawamoto R, Ueki H, Kawakami S. SPYK04, a novel RAF-MEK molecular glue: Dose escalation (DE) in first-in-human study for MAPK pathway-altered solid tumors. 2025 ASCO Annual Meeting 43(16_Suppl), 2025. e-Pub 2025.
Reddy RA, Naing A, Lopez-Berestein G, Rodriguez-Aguayo C, Momin HA, Madhyannapu A, Yuan Y, Pasyar S, Karp DD, Pant S, Piha-Paul SA, Fu S, Tsimberidou AM, Coleman RL, Sood AK, Westin SN. EphA2 siRNA in DOPC nanoliposomes (EPHARNA): A phase I clinical trial in patients with solid tumors. 2025 ASCO Annual Meeting 43(16_Suppl), 2025. e-Pub 2025.
Venturini J, Baysal MA, Chakraborty A, Yap TA, Fu S, Hong DS, Piha-Paul SA, Naing A, Rodon Ahnert J, Dumbrava EE, Beck J, Andersen C, Kahle M, Vining DJ, Meric-Bernstam F, Tsimberidou AM. Clinical outcomes of patients with or without DNA repair pathway alterations by treatment type: The MD Anderson Cancer Center IMPACT 2 study. 2025 ASCO Annual Meeting 43(16_Suppl), 2025. e-Pub 2025.
Piha-Paul SA, Sankhala KK, Menzies AM, Quinones J, Sowell RT, Nambiar P, Shine R, Kacena K, Thomas S, Ali L, Sankar N, Kitada T, Luke JJ, Long GV. Phase I dose escalation trial of STX-001, an LNP-encapsulated self-replicating mRNA expressing IL-12, in patients (pts) with advanced solid tumors. 2025 ASCO Annual Meeting 43(16_Suppl), 2025. e-Pub 2025.
Braganca Xavier C, Lei K, Le Hung Kahle M, Tsimberidou AM, Naing A, Dumbrava EE, Rodon Ahnert J, Pohlmann PR, Piha-Paul SA, Fu S, Champiat S, Yap TA, Tang T-Y, Kopetz S, Meric-Bernstam F, Hong DS. Colorectal cancer with gene fusions: Navigating the genomic landscape and treatment selection in a phase I unit. 2025 ASCO Annual Meeting 43(16_Suppl), 2025. e-Pub 2025.
Uk Lim J, Kang L, Le H, Tang T-Y, Champiat S, Dumbrava EE, Le X, Naing A, Piha-Paul A, Rodon Ahnert J, Tsimberidou AM, Yap TA, Fu S, Meric-Bernstam F, Hong DS. Therapeutic responses in 555 advanced NSCLC patients enrolled in phase I studies at MD Anderson Cancer Center. 2025 ASCO Annual Meeting 43(16_Suppl), 2025. e-Pub 2025.
Fox DA, Bhamidipati D, Lin HY, Hinkle LE, Pham CT, Rodon Ahnert J, Champiat S, Dumbrava EE, Fu S, Kang L, Le H, Meric-Bernstam F, Naing A, Piha-Paul SA, Pohlmann PR, Tang T-Y, Tsimberidou AM, Yap TA, Huey RW, Hong DS. Outcomes of young-onset colorectal cancer vs late-onset colorectal cancer patients on phase 1 matched and non-matched therapies. 2025 ASCO Annual Meeting, 2025. e-Pub 2025.
Gouda M, Gonugunta A, Dumbrava E, Yap TA, Rodon J, Piha-Paul SA, Pohlmann PR, Damodaran S, Murthy R, Valero V, Mouabbi J, Tripathy D, Sahin A, Chen H, Meric-Bernstam. HER2 Loss Following Treatment with Trastuzumab Deruxtecan in Patients with Metastatic Breast Cancer. SABCS 2024 31(12_Suppl), 2025. e-Pub 2025.
Sommerhalder D, Durm GA, Maki R, LoRusso PM, Piha-Paul SA, Bedard PL, Chau N, Venetsanakos E, Hume S, Qiu J, Martorana M, Kieran MW, Da Costa D, Lakhani N. Phase 1 dose escalation and expansion study of the PTK7-targeted antibody-drug conjugate DAY301 in patients with locally advanced or metastatic solid tumors. AACR Annual Meeting 2025 95(8_Suppl_2), 2025. e-Pub 2025.
Torrado C, Tomczak K, Dumbrava EE, Sun B, Ngoi N, Arrechedera C, Para ER, Rodon Anhert J, Piha-Paul SA, Tsimberidou AM, Fu S, Naing A, Pohlmann PR, Hong DS, Meric-Bernstam F, Msaouel P, Haymaker CL, Yap TA. Clinical and translational study of the TGF-β monoclonal antibody SAR439459 in combination with the PD-1 inhibitor cemiplimab for patients (pts) with advanced solid tumors: Results from the phase 1b TACTIC trial. AACR Annual Meeting 2025 85(8_Suppl_2), 2025. e-Pub 2025.
Henry JT, Pavlick AC, Humphries T, Kum S, Gutierrez M, Piha-Paul SA, Vaena D, Sen S, Spira A, Sonpavde G, Harrabi O, Jin F, Bolin NS, Chow LQ, Wan HI, Perez CA. INCLINE-101: A Phase 1/2 Trial of TAC-001 (TLR9 agonist-CD22 mAb) in Advanced or Metastatic Solid Tumors. AACR Annual Meeting 2025 85(8_Suppl_2), 2025. e-Pub 2025.
Braganca Xavier C, Andersen C, Lim JT, Slade JH, Bean SA, Kang L, Le H, Tsimberidou A, Naing A, Hong D, Dumbrava E, Rodon J, Pohlmann P, Piha-Paul S, Champiat S, Yap TA, T-Y T, Meric-Bernstam F, Fu S. Modulating treatment outcomes of patients with solid tumors in immunotherapy trials: a drug interaction analysis from a phase I unit. AACR Annual Meeting 2025 85(8_Suppl_1), 2025. e-Pub 2025.
Piha-Paul SA, Goel S, Liao C-Y, Gbrail NY, Dayyani F, Kazmi S, Lavasani S, Ni S, Sun C, Hennessy K, Wang H, Peng P, Fan J, Javle M. Safety and pharmacokinetics of tinengotinib monotherapy in different doses and dosing schedules in advanced solid tumors. AACR Annual Meeting 2025 85(8_Suppl_1), 2025. e-Pub 2025.
Nelson BE, Nkrumah J, Gouda M, Rodon J, Piha-Paul S, Lim B. Genomic landscape in metaplastic breast cancer: Results from the AACR GENIE Database. AACR Annual Meeting 2025 85(2_Suppl_1), 2025. e-Pub 2025.
Piha-Paul SA, Goel S, C-Y L, Gabrail N, Dayyani F, Kazmi S, Lavasani S, Hennessy K, Wang H, Sun C, Peng P, Fan J, Javle M. Correlation of clinical and biomarker data in FGFR inhibitor failed metastatic cholangiocarcinoma patients with tumor response to tinengotinib. AACR Annual Meeting 2025 85(8_Suppl_1), 2025. e-Pub 2025.
George GC, Lee H, Piha-Paul SA, Dumbrava E, Tsimberidou A, Fu S, Appleton G, Noor L, Rodon J, Yap TA, Meric-Bernstam F, Hong DS. Food choices of patients with advanced cancer at start of early-phase combination trials with immune checkpoint blockade. AACR Annual Meeting 2025, 2025. e-Pub 2025.
Ngoi NYL, Rodon J, Dumbrava EE, Garmezy B, Hong DS, Piha-Paul S, Tsimberidou AM, Fu S, Naing A, Pohlmann PR, Tang T-Y, Clemente H, Rhudy J, Valladolid C, Salguero C, Velez NA, Tran HT, Meric-Bernstam F, Yap TAA. TalaCom: Phase Ib investigator-initiated trial combining talazoparib and axitinib in patients with DNA damage response mutated cancers or BRCA1/2 wildtype ovarian cancer incorporating prospective intrapatient dose titration. ESMO Targeted Anticancer Therapies (TAT) Congress 2025 10(Suppl 2), 2025. e-Pub 2025.
Stephen B, Kwiatkowski E, Anderson MR, Derbala MH, Salih I, Castillo L, Yang Y, Gurses SA, Lim JT, Kiekers AR, Le H, Kang L, Xu M, Ahmed J, Tan HN, Champiat S, T-Y T, Dumbrava EE, Fu S, Piha-Paul SA, Rodon Ahnert J, Tsimberidou AM, Yap T, Yuan Y, Hong DS, Meric-Bernstam F, Bhosale P, Naing A. Impact of liver metastases and systemic biomarkers on immunotherapy response and survival outcomes in patients with solid tumors. AACR IO 2025 13(2_Suppl), 2025. e-Pub 2025.
Piha-Paul S, Tolcher A, Vandross A, Spira A, Armstrong M, Burns M. Phase I dose-escalation trial of AMXT 1501 dicaprate plus difluoromethylornithine: A dual agent approach targeting immunosuppressive polyamine metabolism. SITC 2024 12(Suppl 3), 2024. e-Pub 2024.
Derbala M, McGonagle K, Batra H, Stephen B, Gurses S, Lee S, Hwang W, Hwang S, C-Y O, Gouda M, Castillo L, Zarifa A, Rodriguez E, Hong D, Piha-Paul S, Rodon J, Karp D, Meric-Bernstam F, Raso MG, Naing A. Artificial Intelligence-powered assessment of tumor microenvironment in pre-treatment and on-treatment biopsies informs treatment outcomes to pembrolizumab in patients with rare tumors. SITC 2024 12(Suppl 3), 2024. e-Pub 2024.
Stephen B, Anderson M, Kwiatkowski E, Derbala M, Yang Y, Lim J, Klekers A, Dumbrava E, Fu S, Piha-Paul S, Rodon J, Tsimberidou A, Yap T, Yuan Y, Hong D, Meric-Bernstam F, Bhosale P, Naing A. Impact of liver metastasis on immunotherapy in patients with solid tumors. SITC 2024 12(Suppl 3), 2024. e-Pub 2024.
Donatelli S, Call J, Spira A, Bartolomé, de Miguel M, Chen X, Lakhani N, Panchadbhai S, Piha-Paul S. Tumor Microenvironment Pharmacodynamic Effect of Nemvaleukin Less Frequent Intravenous Dosing in multiple solid tumors: Results from the phase 1/2 ARTISTRY-3 study. SITC 2024 12(Suppl 3), 2024. e-Pub 2024.
Coleman N, Ngoi NYL, Nguyen D, Nelson B, Dumbrava E, Fu S, Hong DS, Karp D, Naing A, Piha-Paul SA, Rodon J, Tsimberidou A, Lim B, Pohlman P, Meric-Bernstam F, Litton JK, Arun B, Yap TA. Poly(ADP-Ribose) Polymerase (PARP) inhibition in metastatic breast cancer: comparison of therapeutic outcomes between patients with BRCA1/2 mutations and other alterations. 36th EORTC-NCI-AACR 211(Suppl 1), 2024. e-Pub 2024.
Subbiah V, Drilon A, Bestvina C, Garon EB, Wirth L, Worden F, Piha-Paul S, Rotow J, Johnson M, Kang H, Dong SM, Weiss J, Pennell NA, Sukrithan V, Lombard A, Szpurka AM, Li J, Manvelyan M, Avsar E, Brose MS. First-in-human, phase 1 study of a selective RET inhibitor, LOXO-260, in patients with RET inhibitor refractory, RET-altered cancers. 36th EORTC-NCI-AACR 211(Suppl 1), 2024. e-Pub 2024.
Patel M, Hamilton E, Piha-Paul S, Henry J, Banerji U, Al-Hallak MN, Okada H, Qian M, Zhang X, Said N, Chatikhine V, Fontana E. Preliminary results from a Phase 1, first-in-human study of DS-9606a, a Claudin 6 (CLDN6)-directed antibody–drug conjugate (ADC), in patients (pts) with tumor types known to express CLDN6. ESMO Congress 2024 35(Suppl 2), 2024. e-Pub 2024.
Fu S, Tsimberidou AM, Dumbrava EE, Yuan Y, McLeod S, Karp D, Rodon J, Yu H, Peng J, Daniel LM, Piha-Paul SA, Naing A, Meric-Bernstam F. Phase I Study of Pamiparib and Cabozantinib in Patients with Metastatic Solid Tumors Harboring Homologous Recombination Deficiency (HRD). ESMO Congress 2024 35(Suppl 2), 2024. e-Pub 2024.
Tsimberidou AM, Fu S, Hong DS, Piha-Paul SA, Naing A, Rodon J, Yap TA, Karp DD, Dumbrava EE, Heymach J, Ajani JA, Cartwright C, Beck J, Andersen CR, Kahle M, Vining DJ, Ross JS, Chao CY, Berry DA, Meric-Bernstam F. Final Results of IMPACT 2, a Randomized Study Evaluating Molecular Profiling and Targeted Agents in Metastatic Cancer at MD Anderson Cancer Center. ESMO Congress 2024 35(Suppl 2), 2024. e-Pub 2024.
Luo J, Kim J, Walton S, Nguyen T, Paik P, Chaft J, Hsu R, Piha-Paul S, Janne P, Sholl L, DuBois S, Hanna G, Shapiro G, French C. Molecular characterization of NUT carcinoma: A report from the NUT carcinoma registry. 2024 ASCO Annual Meeting 42(suppl 16), 2024. e-Pub 2024.
George G, Piha-Paul S, Dumbrava E, Subbiah V, Fu S, Tsimberidou A, Pant S, Appleton G, Noor L, Yap T, Rodon Ahnert J, Meric-Bernstam F, Cleeland C, Mendoza T, Hong D. Patient-reported symptom interference with activity- and mood-related functioning prior to start of an early-phase oncology combination trial including immune checkpoint blockade. 2024 ASCO Annual Meeting 42(suppl 16), 2024. e-Pub 2024.
Garralda E, Wang J, Gianoukakis A, Taylor M, Spigel D, Piha-Paul S, Morgensztern D, Arnold S, Alonso G, García-Pardo M, García-Corbacho J, Forster M, Krebs M, Italiano A, Subbiah V, Serrano S, Fisher G, Brook S, Arkenau H-T, Garrido P. A phase-1 dose escalation and expansion study of EP0031, a next-generation selective RET inhibitor (SRI), in patients with SRI-naïve or pretreated advanced RET-altered NSCLC and other tumors. 2024 ASCO Annual Meeting 42(suppl 16), 2024. e-Pub 2024.
Gouda M, Lin H, Kang L, Le H, Dumbrava E, Fu S, Karp D, Tsimberidou A, Naing A, Piha-Paul S, Pohlmann P, Rodon Ahnert J, Yap T, Meric-Bernstam F, Hong D. Response to RAF/MEK/ERK inhibitors in patients with RAS altered and wild-type tumors. 2024 ASCO Annual Meeting 42(suppl 16), 2024. e-Pub 2024.
Fu S, Piha-Paul S, Singh S, Peng J, Keenan B, Mei J, Lynch K, Li L, Song M, Zhang X. A first-in-human phase I study of ATG-031, anti-CD24 antibody, in patients with advanced solid tumors or B-cell non-Hodgkin lymphomas (PERFORM). 2024 ASCO Annual Meeting 42(suppl 16), 2024. e-Pub 2024.
McKean M, Hutson T, Piha-Paul S, Micaily I, Liao M, Humphreys R, Brock G, Sahr N, Amber V, Spira A. A phase 1/1b first-in-human (FIH) study of JZP898 as monotherapy and in combination with pembrolizumab in adult patients with advanced or metastatic solid tumors. 2024 ASCO Annual Meeting 42(suppl 16), 2024. e-Pub 2024.
Torrado Martin C, Rai K, Moawad M, Dumbrava E, Fu S, Hong D, Karp D, Meric-Bernstam F, Naing A, Pohlmann P, Rodon Ahnert J, Tsimberidou A, Yap T, Said R, Pelosof L, Piha-Paul S. A phase 1 study of the BET inhibitor ZEN003694 in combination with the MEK1/2 inhibitor binimetinib in solid tumors with RAS pathway alterations and triple-negative breast cancer (NCI number 10449). 2024 ASCO Annual Meeting 42(suppl 16), 2024. e-Pub 2024.
Foldi J, Piha-Paul S, Villaruz L McArthur H, Olson M, Jonathan E, Ostrander B, Krishnan K, Luke J. A phase 1 dose-escalation and expansion study of an intratumorally administered dual STING agonist (ONM-501) alone and in combination with cemiplimab in patients with advanced solid tumors and lymphomas. 2024 ASCO Annual Meeting 42(suppl 16), 2024. e-Pub 2024.
Gouda M, Shunyakova J, Naing A, Dumbrava E, Hong D, Yuan Y, Yang P, Myers A, Liang Y, Ping J, Karp D, Tsimberidou A, Rodon Ahnert J, Yap T, Piha-Paul S, Meric-Bernstam F, Fu S. A phase I study of TAK-659 and paclitaxel in patients with taxane-refractory advanced solid tumors. 2024 ASCO Annual Meeting 42(suppl 16), 2024. e-Pub 2024.
Peters S, Hollebecque A, Sehgal K, Lopez J, Calvo E, Dowlati A, Bockorny B, Perez C, Sanborn R, Patnaik A, Fontana E, Galvao V, Kingsley E, Patilea-Vrana G, Wang T, Knonwles S, Piha-Paul S. Efficacy and safety of sigvotatug vedotin, an investigational ADC, in NSCLC: Updated phase 1 results (SGNB6A-001). 2024 ASCO Annual Meeting 42(suppl 16), 2024. e-Pub 2024.
Luke J, Kennedy L, Sankar N, Menzies A, van Akkooi A, Gonzalez M, Urban J, Gill M, Atkins C, Quiñones J, Miller B, Duhamel A, Sowell R, Nambiar P, Kitada T, Piha-Paul S, Sankhala K, Long G. A phase I trial of intratumoral STX-001: A novel self-replicating mRNA expressing IL-12 alone or with pembrolizumab in advanced solid tumors. 2024 ASCO Annual Meeting 42(suppl 16), 2024. e-Pub 2024.
Villalona-Calero M, D-Y O, Garralda E, Vieito M, Huang J, Piha-Paul S. A phase 1 study evaluating the safety, pharmacokinetics, and efficacy of fadraciclib, an oral CDK2/9 inhibitor, in patients with advanced solid tumors and lymphoma. 2024 ASCO Annual Meeting 42(suppl 16), 2024. e-Pub 2024.
Piha-Paul S, De La Fuente M, Iwamoto F, Nagpal S, Weise A, J-J Z, Chandra S, Chen C, Fu Y, Yang Z, Tsai K. Interim analysis of ABM-1310, a blood-brain barrier-penetrant BRAF inhibitor, in patients with BRAF V600-mutated solid tumors. 2024 ASCO Annual Meeting 42(suppl 16), 2024. e-Pub 2024.
Piha-Paul S, Call J, Spira A, Bartolome J, de Miguel MJ, Du Y, DiLea C, Panchabhai S, Lakhani N. Recommended phase 2 dose (RP2D) of nemvaleukin alfa in patients (pts) with advanced solid tumors treated with less frequent intravenous (IV) dosing (ARTISTRY-3). 2024 ASCO Annual Meeting 42(suppl 16), 2024. e-Pub 2024.
Tsimberidou A, Fu S, Hong D, Piha-Paul S, Naing A, Rodon Ahnert J, Yap T, Karp D, Dumbrava E, Heymach J, Ajani J, Cartwright C, Beck J, Andersen C, Kahle M, Vining D, Ross J, Chao C, Berry D, Meric-Bernstam F. Results of IMPACT 2, a randomized study evaluating molecular profiling and targeted agents in metastatic cancer at MD Anderson Cancer Center. 2024 ASCO Annual Meeting 42(suppl 16), 2024. e-Pub 2024.
Torrado Martin C, Brink A, Gouda M, Kang L, Osburn J, Patterson C, Charles S, Poullard A, Urschel G, Dumbrava E, Karp D, Naing A, Piha-Paul S, Pohlmann P, Rodon Ahnert J, Tsimberidou A, Yap T, Hong D, Meric-Bernstam F, Fu S. Telehealth consultations and recruitment trends in clinical trials: A retrospective analysis at investigational cancer therapeutics, a dedicated phase I department at The University of Texas MD Anderson Cancer Center. 2024 ASCO Annual Meeting 42(suppl 16), 2024. e-Pub 2024.
Fu S, Piha-Paul S, Singh S, Peng J, Keenan B, Mei J, Lynch K, Li L, Song M, Zhang X. A first-in-human phase I study of ATG-031, anti-CD24 antibody, in patients with advanced solid tumors or B-cell non-Hodgkin lymphomas (PERFORM). J Clin Oncol 42(suppl 16), 2024. e-Pub 2024.
Dudek A, O'Shaugnessy J, Piha-Paul S, Uprety D, Kitchens B, Hutson T, Rank B, Stokes M, Dudgeon C, Surguladze D, Lightcap E, Drees J, Harrison B, Li R, LaCayo A, Mattson P, Bose N, Karim D, Gargano M, Iglesias J. A multicenter, open‑label, phase 1a study of HC‑5404 in patients with advanced solid tumors 42(suppl 16), 2024. e-Pub 2024.
Piha-Paul SA, Xu B, Fan Y, Yuan Y, Lavasani S, Mortimer J, Goel S, Tsimberidou A, Ibrahim N, Abouharb S, Barcenas C, Iheme A, Karp D, Rodon Ahnert J, Dumbrava E, Fan J, Peng P, Sun C, Wang H, Hennessy K, Fu X, Xu R, Ni S, Wu F, Meric-Bernstam F. The efficacy and safety of tinengotinib in patients with advanced or metastatic HR+/HER2-breast cancer or TNBC. San Antonio Breast Cancer Symposium 2023 84(9_Suppl), 2024. e-Pub 2024.
Yap T, Dumbrava E, Rodon Ahnert J, Tsimberidou A, Hong D, Piha-Paul S, Karp D, Fu S, Naing A, Pohlmann P, Rhudy J, Berenji-Jalaei S, Cole A, Valladolid C, Dufner D, Bockorny B, Bullock A, Fein D, Buchbinder E, Choudhury A, Haddox C, Lee E, Wulf G, Ivy P, Said R, Shapiro G, Meric-Bernstam F. NCI10217: Phase Ib biomarker-driven tumor-agnostic combination (Combo) trial of copanlisib (Copa) and olaparib (Ola) in molecularly-selected patients (pts) with advanced cancers with PIK3CA hotspot, PTEN and DNA damage response (DDR) mutations. AACR Annual Meeting 2024 84(7_Suppl), 2024. e-Pub 2024.
Piha-Paul S, C-Y L, Fonkoua L, Mahipal A, Goel S, Fountzilas C, Shen L, Li D, Deming D, Dayyani F, Han W, Niu Z, Fan J, Peng P, Wang H, Huang P, Wu F, Javle M. Tinengotinib in patients with advanced solid tumors harboring actionable FGFR1-3 mutations. AACR Annual Meeting 2024 84(6_Suppl), 2024. e-Pub 2024.
Uzunparmak B, Su F, Johnson AM, Nomie K, Fowler N, Kontselidze L, Bagaev A, Butusova A, Dumbrava EE, Rodon-Ahnert J, Fu S, Hong DS, Yap TA, Naing A, Piha-Paul SA, Karp DD, Pohlmann PR, Tsimberidou AM, Patel KP, Meric-Bernstam F. Comprehensive genomic and transcriptomic analysis to guide therapy for patients with metastatic solid tumors. AACR Annual Meeting 2024 84(6_Suppl), 2024. e-Pub 2024.
Hongqian G, Kumar Subudhi S, Han W, C-Y L, Zhang S, Dai T, Peng P, Sun C, Wang H, Hennessy K, Fu X, Yu Y, Wu Y, Xu R, Huang P, Neo L, Wu F, Fan J, Piha-Paul SA. The efficacy and safety of tinengotinib in patients with heavily pretreated metastatic castration-resistant prostate cancer (mCRPC). 2024 ASCO Genitourinary Cancers Symposium 42(Suppl 4), 2024. e-Pub 2024.
Bhamidipati D, Haro-Silerio J, Dumbrava E, Fu S, Hong D, Karp D, Naing A, Pant S, Piha-Paul S, Rodon Ahnert J, Tsimberidou A, Johnson A, Lee M, Raghav K, Morris V, Overman M, Kopetz S, Meric-Bernstam F, Yap T, Dasari A. Clinical characterization and therapeutic outcomes of patients (pts) with colorectal cancer (CRC) harboring somatic BRCA1/2 mutations. ASCO Gastrointestinal Cancers Symposium 42(Suppl 3), 2024. e-Pub 2024.
Prenen H, Lesimple T, Robert M, Machiels J-P, Delafontaine B, Tomasini P, Meniawy T, Kotecki N, Cutsem EV, Piha-Paul S, Schweizer M, Gadgeel S, Kodo S, Ouali K, Kuboki Y, Daniel J, Ebiana V, Howe J, Spitz S, Italiano A. A Phase 1 Study Exploring the Safety and Tolerability of the Small-Molecule PD-L1 Inhibitor INCB099280 in Select Advanced Solid Tumors. ESMO Immuno-Oncology Symposium 20(Suppl), 2023. e-Pub 2023.
George GC, Piha-Paul SA, Fu S, Dumbrava E, Subbiah V, Tsimberidou A, Blumenschein G, Pant S, Appleton G, Noor L, Rodon Ahnert J, Yap T, Meric-Bernstam F, Cleeland C, Mendoza T, Hong DS. Patient-reported baseline symptomatic adverse events in early-phase trials of combination treatments with immune checkpoint blockade, and their association with concurrent global health status, health utilities and clinical factors. AACR-NCI-EORTC International Conference on Moledular Targets and Cancer Therapeutics 22(12_Suppl), 2023. e-Pub 2023.
Garralda E, Guzman A, Garrido P, Gianoukakis AG, Taylor M, Piha-Paul S, Krebs MG, Italiano A, Clark L, Fisher G, Arkenau T, Subbiah V. Preliminary results from a phase I/II study evaluating the safety, tolerability, and efficacy of EP0031, a next generation selective RET inhibitor, in patients with advanced RET-altered malignancies. AACR-NCI-EORTC International Conference on Moledular Targets and Cancer Therapeutics 22(12_Suppl), 2023. e-Pub 2023.
Ahmed J, Stephen B, Beyaz S, Chung C, Kilic E, Khawaja MR, Yang Y, Nick AM, Raso MG, Toro EB, Karp DD, Piha-Paul SA, Sood A, Ng C, Johnson AM, Soliman PT, Meric-Bernstam F, Lu KH, Naing A. Temsirolimus in combination with metformin in patients with advanced or recurrent endometrial cancer. AACR-NCI-EORTC International Conference on Moledular Targets and Cancer Therapeutics 22(12_Suppl), 2023. e-Pub 2023.
Hamid O, Piha-Paul S, Liu S, Boccia R, Call J, Wise-Draper T, Alistar AT, Olszanski A, Wrangle J, Shields A, Manzano A, Calvo E, Panchabhai S, Asha S, Du Y, Mayo C, Rider L, Ernstoff M. Subcutaneous nemvaleukin alfa in combination with pembrolizumab in patients with refractory solid tumors (ARTISTRY-2). SITC Annual Meeting 20023 11(Suppl 1), 2023. e-Pub 2023.
Piha-Paul S, Call J, Spira A, Manzano A, Calvo E, de Miguel M, Asha S, Du Y, DiLea C, Rege B, Dalal R, Panchabhai S, Lakhani N. Assessment of safety and immunologic activity of nemvaleukin alfa in patients with advanced solid tumors treated with less frequent intravenous dosing (ARTISTRY-3). SITC Annual Meeting 2023 11(Suppl 1), 2023. e-Pub 2023.
Bupathi M, Wang J, Hu-Lieskovan S, Piha-Paul S, Chmielowski B, Garmezy B, Najjar Y, Stein M, Yao L, Kanodia J, Clynes R, McGovern P, Thompson B. A phase 1, first-in-human (FIH), open-label, dose-finding and expansion study of XmAb808, a B7H3 x CD28 bispecific antibody, in combination with pembrolizumab in patients with advanced solid tumors. SITC Annual Meeting 223 11(Suppl 1), 2023. e-Pub 2023.
Yap TA, Piha-Paul SA, Karp D, Dumbrava EE, Hong DS, Fu S, Subbiah V, Tsimberidou AM, Rodon J, Rhudy J, Valladolid C, Yuan Y, Jana B, Spiliopoulou P, Randall L, Poklepovic A, Sehgal K, Shapiro GI, Said R, Meric-Bernstam F. NCI10221: Phase II Multicenter Biomarker Driven Combination Trial of Copanlisib and Nivolumab in Patients with Molecularly-selected Advanced Solid Tumors (BaCoN). ESMO Congress 2023 34(Suppl 2):S487-S488, 2023. e-Pub 2023.
Patel MR, Doi T, Koyama T, Falchook GS, Friedman CF, Piha-Paul SA, Gutierrez M, Awad MM, Mattour AH, Satoh T, Okamoto N, Singh J, Yoshizuka N, Qian M, Qian X, Tran BP Dosunmu O, Lu P, Johnson ML. Ifinatamab deruxtecan (I-DXd; DS-7300) in patients with advanced solid tumors: Updated clinical and biomarker results from a phase I/II study. ESMO Congress 2023 34(Suppl 2), 2023. e-Pub 2023.
Javle M, Kankeu Fonkoua L, Mahipal A, Liao C-Y, Fountzilas C, Li D, Pelster M, Goel S, Peng P, Sun C, Wang H, Hennessy K, Fu X, Neo L, Shan Y, Huang P, Wu D, Wu F Fan J, Piha-Paul SA. Tinengotinib in Patients with Advanced, Fibroblast Growth Factor Receptor (FGFR) inhibitor Refractory/Relapsed Cholangiocarcinoma. ESMO Congress 2023 34(Suppl 2):S215-S216, 2023. e-Pub 2023.
Johnson B, Willis J, Williams C, Wang X, Smith G, You YN, Dumbrava E, Fu S, Karp D, Naing A, Piha-Paul S, Rodon Ahnert J, Tsimberidou A, Yap T, Overman M, Pant S, Hong D, Kopetz S, Meric-Bernstam F, Subbiah V. Molecular landscape and survival outcomes on early phase clinical trials in sporadic young onset colorectal cancer. 2023 ASCO Annual Meting 41(Suppl 16), 2023. e-Pub 2023.
George GC, Piha-Paul SA, Fu S, Rodon Ahnert J, Yap TA, Subbiah V, Dumbrava E, Tsimberidou A, Pant S, Appleton G, Noor L, Meric-Bernstam F, Cleeland CS, Mendoza TR, Hong DS. Baseline symptom, health status, and health utilities in patients in early-phase clinical trials combining immune checkpoint blockade with other anticancer therapies. 2023 ASCO Annual Meeting 41(Suppl 16), 2023. e-Pub 2023.
Luo J, Lee E, Sanchez M, Finstein B, Hertzler H, Luong N, Tamen R, NguyenT, Paik PK, Chaft JE, Piha-Paul SA, Janne PA, Sholl LM, Cheng ML, DuBois SG, Hanna GJ, Nishino M, Shapiro G, French CA. Initial chemotherapy for locally advanced and metastatic NUT carcinoma: A report from the NUT Carcinoma Registry. 2023 ASCO Annual Meeting 41(Suppl 16), 2023. e-Pub 2023.
Nardo M, Reilley M, Biter A, Lim JA, Bean S, Nguyen L, Bhosale P, Ager C, Couillault C, Piha-Paul S, Fu S, Tsimberidou A, Yap T, Naing A, Rodon Ahnert J, Subbiah V, Karp D, Curran M, Hong D. Lefitolimod (TLR agonist) and ipilimumab in patients with advanced solid tumors: A phase I trial. 2023 ASCO Annual Meeting 41(Suppl 16), 2023. e-Pub 2023.
Falchook G, Liang Y, Harvey D, Fu S, Weitao Y, Qin Y, Zhang X, Henry J, Zou Q, Shan B, Liang P, Wang C, Li W, Pamuklar Z, Pei Y, Chang Z, Wang J, Piha-Paul S, Bhave M, Yin Y. First-in-human phase 1 study of pimicotinib (ABSK021), a CSF-1R inhibitor, in patients with advanced solid tumors. 2023 ASCO Annual Meeting 41(Suppl 16), 2023. e-Pub 2023.
Piha-Paul S, Goel S, C-Y L, Gabrail N, Dayyani F, Kazmi S, Yuan Y, Lavasani S, Fan J, Peng P, Sun C, Wang H, Hennessy K, Fu X, Ni S, Tan HX, Ngo B, Ru Q, Wu F, Javle M. Preliminary safety and efficacy of tinengotinib tablets as monotherapy and combination therapy in advanced solid tumors: A phase Ib/II clinical trial. 2023 ASCO Annual Meeting 41(Suppl 16), 2023. e-Pub 2023.
Sommerhalder D, Piha-Paul S, Pelster M, Borad M, Vandross A, Spira A, Perez S, Brinton L Kelly K, Ramanathan R, Reilley M. A phase 1/2, first-in-human trial of ZB131, a novel antibody targeting cancer-specific plectin (CSP) in advanced solid tumors. 2023 ASCO Annual Meeting 41(Suppl 16), 2023. e-Pub 2023.
Piha-Paul S, Nagpal S, Weise A, Braiteh F, Chen C, Huang C, Liu W, Hu Y, Yang Z, Tsai K. A phase 1, multicenter, open-label study of a new BRAF inhibitor ABM-1310 in adult patients (pts) with BRAFv600-mutated solid tumors. 2023 ASCO Annual Meeting 41(Suppl 16), 2023. e-Pub 2023.
Nelson B, Roszik J, Noia Barreto CM, Nardo M, Ahmed J, Campbell E, Johnson A, Piha-Paul S, Glitza I, Westhers S-P, Cabanillas M, Javle M, Meric-Bernstam F, Subbiah V. RAF-inhibitor rechallenge therapy in BRAF aberrated pan-cancers: RE-RAFFLE study. 2023 ASCO Annual Meeting 41(Suppl 16), 2023. e-Pub 2023.
Nelson B, Sheth R, Kelly K, Park H, Patel S, McKinley D, O'Brien S, Parra Palau JL, Piha-Paul S. First in human phase Ⅰ study of BMS-986299 as monotherapy and combined with nivolumab and ipilimumab in advanced solid tumors. 2023 ASCO Annual Meeting 41(Suppl 16), 2023. e-Pub 2023.
Hollebecque A, Lopez J, Piha-Paul S, Dowlati A, Patnaik A, Galvao V, Bockorny B, Sehgal K, Kingsley E, Sanborn R, Perez C, Peters S, Yan M, Nazarenko N, Calvo E. SGN-B6A, an integrin beta-6 (ITGB6)-targeted antibody-drug conjugate (ADC), in patients with advanced solid tumors: Updated results from a phase 1 study (SGNB6A-001). 2023 ASCO Annual Meeting 41(Suppl 16), 2023. e-Pub 2023.
Nardo M, Gouda M, Ahmed J, Noia Barreto CM, Nelson B, Araujo D, Blumenschein G, Tsimberidou A, Piha-Paul S, Dumbrava E, Hong D. Predictors of survival outcomes in patients (pts) with advanced solid tumors treated with cellular therapies in early clinical trials. 2023 ASCO Annual Meeting 41(Suppl 16), 2023. e-Pub 2023.
Davidson T, Le H, Campbell E, Ozenne C, Dumbrava E, Fu S, Hong D, Karp D, Naing A, Piha-Paul S, Rodon Ahnert J, Tsimberidou A, Yap T, Meric-Bernstam F, Subbiah V. Clinical trial deserts: US urban vs rural patient enrollment among patients with advanced cancer in phase 1 clinical trials at a major cancer center. 2023 ASCO Annual Meeting 41(Suppl 16), 2023. e-Pub 2023.
Ngoi NY, Lin HY, Dumbrava E, Fu S, Karp DD, Naing A, Pant S, Piha-Paul SA, Rodon J, Subbiah V, Tsimberidou AM, Campbell E, Urrutia S, Hong DS, Meric-Bernstam F, Yuan Y, Yap TA. Dynamic changes in monocyte and reticulocyte counts predict mechanism-based anemia development and recovery during ATR inhibitor treatment in phase I/II trials. AACR Annual Meeting 2023 83(7_Suppl), 2023. e-Pub 2023.
Lemech C, Zhou C, Zhan X, Shi Y, Liu J, Piha-Paul SA, Richardson G, Qin G, Song PH, Shi L, Sun Y, Xia Y. GQ1001: A next generation HER2-targeting ADC that exhibits promising early clinical efficacy with excellent tolerance in a multi-center, Phase Ia study. AACR Annual Meeting 2023 83(8_Suppl), 2023. e-Pub 2023.
Jamal S, Nagrial A, Carlino M, Cosman R, Joshua A, Eek R, Piha-Paul S, Hamid O, Liu J. ENB-003, an ETBR antagonist, in combination with pembrolizumab for advanced solid tumor: The ENBolden trial. AACR Annual Meeting 2023 83(8_Suppl), 2023. e-Pub 2023.
Nelson BE, Janku F, Fu S, Dumbrava EI, Hong DS, Karp D, Naing A, Rodon J, Tsimberidou A, Amaria RN, Conley A, Damodaran S, Raghav KPS, Kreider BL, Tung D, Varterasian M, Khazaie K, Piha-Paul S. Phase Ib study of pembrolizumab in combination with intratumoral injection of clostridium novyi-NT in patients with advanced solid tumors. AACR Annual Meeting 2023 83(8_Suppl), 2023. e-Pub 2023.
Uzunparmak B, Haymaker C, Raso G, Zhu C, Masciari S, Wang L, Kirby B, Lin H, Gorur A, Cimo A-M, Kennon A, Ding Q, Palmieri A, Urschel GE, Yuan Y, Feng G, Rizvi Y, Hussain A, Subbiah V, Yap TA, Rodon-Ahnert J, Piha-Paul SA, Hong DS, Meric-Bernstam F, Dumbrava EE. HER2-low expression in patients with advanced or metastatic solid tumors. AACR Annual Meeting 2023 83(7_Suppl), 2023. e-Pub 2023.
Le Torneau C, Piha-Paul SA, Prenen H, Delafontaine B, Pinato DJ, Santoro A, Kristeleit R, Spencer KR, Gandadhar TC, Burris H, Kotecki N, Basu B, Graham DM, Di Gaicomo AM, Sahebjam S, Di Nicola M, Gomez-Roca C, Tomasini P, Ascierto PA, Curigliano G, Karasic T, Geschwindt R, Daniel J, Van Cutsem E. A phase 1 study exploring the safety and tolerability of the small molecule PD-L1 inhibitor, INCB086550, in patients with select advanced tumors. SITC Annual Meeting 2022 10(Suppl. 2):A804, 2022. e-Pub 2022.
Hollebecque A, Lopez J, Piha-Paul SA, Dowlati A, Patnaik A, Galvao V, Buckorny B, Sehgal K, Kingsley E, Sanborn RE, Peters S, Sun Y, Patilea-Vrana G, Nazarenko N, Calvo E. A first-in-human trial of an integrin beta-6 targeted antibody-drug conjugate (ADC), SGN-B6A, in patients with advanced solid tumors: Interim results of a Phase 1 study (SGNB6A-001). SITC Annual Meeting 2022 10(Suppl. 2):A762, 2022. e-Pub 2022.
Piha-Paul SA, Bourayou N, Schaub R, Yang Y-O, Wei W, Mayes P, Gangadhar TC. A phase 1, first-in-human, open-label, multicenter study of INCA32459, a bispecific anti-PD1 and anti-LAG-3 antibody, in patients with select advanced malignancies. SITC Annual Meeting 2022 10(Suppl. 2):A755, 2022. e-Pub 2022.
Prenen H, Lesimple T, Robert M, Delafontaine B, Machiels J-P, MeniawyT, Van Cutsem E, Kotecki N, Piha-Paul SA, Schweizer MT, Gadgeel SM, Daniel J, Viviers L, Howe J, Italiano A. A phase 1 study exploring the safety and tolerability of the small-molecule PD-L1 inhibitor, INCB099280, in patients with select advanced solid tumors. SITC Annual Meeting 2022 10(Suppl. 2):A765, 2022. e-Pub 2022.
Yap TA, Ngoi N, Dumbrava EE, Karp DD, Rodon Ahnert J, Fu S, Hong DS, Naing A, Pant S, Piha-Paul SA, Subbiah V, Tsimberidou AM, Dufner D, Rhudy J, Gore S, Ivy SP, Yuan Y, Westin SN, Mills GB, Meric-Bernstam F. NCI10329: Phase Ib Sequential Trial of Agents against DNA Repair (STAR) Study to investigate the sequential combination of the Poly(ADP-Ribose) Polymerase inhibitor (PARPi) olaparib (ola) and WEE1 inhibitor (WEE1i) adavosertib (ada) in patients (pts) with DNA Damage Response (DDR)-aberrant advanced tumors, enriched for BRCA1/2 mutated and CCNE1 amplified cancers. 34th EORTC-NCI-AACR Symposium 174(Suppl 1):S7, 2022. e-Pub 2022.
Goldman J, Martinez Bueno A, Dooms C, Jhaveri K, de Miguel MJ, Piha-Paul SA, Unni N, Mahipal A, Suga JM, Naltet C, Zick A, Antonanzas Basa M, Crown J, Chae YK, DiPrimeo D, Eli LD, McCulloch L, Mahalingam D. Neratinib efficacy in patients with EGFR exon 18-mutant non-small-cell lung cancer: findings from the SUMMIT basket trial. Eur J Cancer: Abstracts, 34th EORTC-NCI-AACR Symposium 174(Suppl 1):S82, 2022. e-Pub 2022.
Piha-Paul S, Oh DY, Garralda E, Vieito M, Huang J, Kirschbaum M, Villanona-Calero M. A phase 1/2, open-label, multicenter study to investigate the safety, pharmacokinetics, and efficacy of fadraciclib (CYC065), an oral CDK2/9 inhibitor, in subjects with advanced solid tumors and lymphoma. 34th EORTC-NCI-AACR Symposium 174(Suppl 1):S17-S18, 2022. e-Pub 2022.
Ngoi, NY, Pilie, PG, Piha-Paul, SA, Dumbrava, EE, Fu, S, Hong, DS, Karp, DD, Naing, A, Pant, S, Rodon Ahnert, J, Subbiah, V, Tsimberidou, AM, Salguero, C, Brown, CV, Hoadley, WE, Johnson, A, Yuan, Y, Westin, SN, Meric-Bernstam, F, Yap, TA. DNA Damage Response (DDR) Basket of Baskets (D-BOB) Trial: Pase 1/2 Study of the ATR Inhibitor (ATRi) berzosertib and PD-L1 inhibitor avelumab in patients (pts) with advanced solid tumors with DDR molecular alterations. 34th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer therapeutics 174(Suppl 1):S10, 2022. e-Pub 2022.
Ngoi N, Pilie PG, Piha-Paul SA, Dumbrava EE, Fu S, Hong DS, Karp DD, Naing A, Pant S, Rodon Ahnert J, Subbiah V, Tsimberidou AM, Salguero C, Brown CV, Hoadley WE, Johnson A, Yuan Y, Westin SN, Meric-Bernstam F, Yap TA. DNA Damage Response (DDR) Basket of Baskets (D-BOB) Trial: Phase 1/2 Study of the ATR inhibitor (ATRi) berzosertib and PD-L1 inhibitor avelumab in patients (pts) with advanced solid tumors with DDR molecular alterations. 34th EORTC-NCI-AACR Symposium 174(Suppl 1), 2022. e-Pub 2022.
Ngoi NY, Lin H, Ileana Dumbrava EE, Fu S, Karp D, Naing A, Pant S, Rodon J, Piha-Paul SA, Subbiah V, Tsimberidou AM, Campbell E, Urrutia S, Hong DS, Meric-Bernstam F, Yuan Y, Yap TA. Correlation of clinical, genomic and hematological parameters with ATR inhibitor (ATRi) outcomes in phase I/II clinical trials. ESMO Congress 2022 33(Suppl 7):S761-S762, 2022. e-Pub 2022.
Doi T, Patel M, Falchook G, Koyama T, Friedman C, Piha-Paul S, Gutierrez M, Abdul-Karim R, Awad M, Adkins D, Takahashi S, Kadowaki S, Cheng B, Ikeda N, Laadem A, Yoshizuka N, Qian M, Dosunmu O, Arkenau HT, Johnson M. DS-7300 (B7-H3 DXd Antibody Drug Conjugate [ADC]) Shows Durable Antitumor Activity in Advanced Solid Tumors: Extended Follow-up of a Phase 1/2 Study. ESMO Congress 2022 33(Suppl 7):S744-S745, 2022. e-Pub 2022.
DiPeri TD, Kong K, Karp DD, Ajani JA, Pant S, Piha-Paul SA, Dumbrava EI, Meric-Bernstam F. Discordance of HER2 expression and/or amplification on repeat testing. AACR Annual Meeting 2022 82(12_Supplement), 2022. e-Pub 2022.
Piha-Paul SA, Gupta M, Oh D-Y, Hong Kim Y, Young Rha S, Kang Y-K, Garcia MD, Fleitas Kanonnikoff T, Arrazubi Arrula V, Aviano K, Demuth T, Ku G. A phase 2, multi-center, open-label study of cinrebafusp alfa (PRS-343) in combination with ramucirumab and paclitaxel in patients with HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma and in combination with tucatinib in patients with HER2 low gastric or gastroesophageal junction (GEJ) adenocarcinoma. AACR Annual Meeting 2022 82(12_Supplement), 2022. e-Pub 2022.
Nelson BE, Roszik J, Janku F, Hong D, Kato S, Naing A, Piha-Paul SA, Fu S, Tsimberidou A, Cabanillas M, Busaidy N, Javle M, Byers L, Heymach J, Meric-Bernstam F. B-Raf V600E harboring non-melanoma cancers treated with Vemurafenib monotherapy and in combination with Everolimus/Sorafenib/Crizotinib/Paclitaxel+ Carboplatin: A pooled analysis of five phase 1/2 studies. AACR Annual Meeting 2022 82(12_Supplement), 2022. e-Pub 2022.
Piha-Paul SA, Elliott CF, Du Y, Graham JR, Desai M, Wang Y, Dalal RP, Lakhani NJ. ARTISTRY-3: Effect of nemvaleukin alfa with a less frequent IV dosing schedule as monotherapy and in combination with pembrolizumab and impact on the tumor microenvironment (TME) in patients (pts) with advanced solid tumors. 2022 ASCO Annual Meeting 40(Suppl. 16), 2022. e-Pub 2022.
Piha-Paul SA, Xu B, Singh Raghav KP, Meric-Bernstam F, Janku F, Dumbrava EE, Fu S, Karp DD, Rodon Ahnert J, Conley AP, Mott F, Ajani JA, Hong DS, Fan Y, Peng P, Levin WJ, Ngo B, Ru QC, Wu F, Javle MM. First-in-human, phase I study of TT-00420, a multiple kinase inhibitor, as a single agent in advanced solid tumors. 2022 ASCO Annual Meeting 40(Suppl. 16), 2022. e-Pub 2022.
Ngoi N, Lin HY, Dumbrava EE, Fu S, Karp DD, Naing A, Pant S, Piha-Paul SA, Rodon Ahnert J, Subbiah V, Tsimberidou AM, Campbell E, Hong DS, Meric-Bernstam F, Yuan Y, Yap TA. Baseline predictors of hematological toxicity in patients with advanced cancer treated with ATR inhibitors in phase I/II clinical trials. 2022 ASCO Annual Meeting 40(Suppl. 16), 2022. e-Pub 2022.
Coleman N, DiPeri TP, Nguyen D, Naing A, Piha-Paul SA, Tsimberidou AM, Zheng X, Johnson A, Wang W, Shaw KR, Dumbrava EE, Fu S, Rodon J, Rodon Ahnert J, Hong DS, Subbiah V, Yap TA, Luthra R, Patel KP, Meric-Bernstam F. Repeat large panel genomic sequencing identifies actionable alterations and characterizes the genomic landscape in patients with metastatic solid tumors. 2022 ASCO Annual Meeting 40(Suppl. 16), 2022. e-Pub 2022.
Nelson BE, Saleem S, Damodaran S, Somaiah N, Piha-Paul SA, More JA, Yilmaz B, Karp DD, Dumbrava EE, Tsimberidou AM, Hong DS, Rodon Ahnert J, Booser DJ, Ibrahim NK, Conley AP, Bhosale P, Rojas Hernandez CM, Tripathy D, Naing A, Meric-Bernstam F. Phase Ib study of selinexor and eribulin combination in advanced solid tumors and triple-negative breast cancer. 2022 ASCO Annual Meeting 40(Suppl. 16), 2022. e-Pub 2022.
Harding JJ, Piha-Paul SA, Shah RH, Cleary JM, Quinn DI, Brana I, Moreno V, Borad MJ, Loi S, Spanggaard I, Ford JM, DiPrimeo D, Berger MF, DeFazio Eli L, Meric-Bernstam F, Solit DB, Abou-Alfa GK. Targeting HER2 mutation–positive advanced biliary tract cancers with neratinib: Final results from the phase 2 SUMMIT basket trial. 2022 ASCO Annual Meeting 40(Suppl. 16), 2022. e-Pub 2022.
Nelson BE, Andersen C, Yuan Y, Hong DS, Naing A, Karp DD, Yap TA, Rodon Ahnert J, Campbell E, Tsimberidou AM, Dumbrava EE, Fu S, Piha-Paul SA, Pant S, Blumenschein GR, Altan M, Tawbi HA, Tannir NM, Meric-Bernstam F, Subbiah V. Effect of immunotherapy and time-of-day infusion chronomodulation on survival in advanced cancers+A935:W935. 2022 ASCO Annual Meeting 40(Suppl. 16), 2022. e-Pub 2022.
Alhalabi O, Tannir NM, Momin HA, Yilmaz B, Stephen B, Ejezie CL, Moyers JT, Gurses SA, How J, Fu S, Rodon Ahnert J, Hong DS, Piha-Paul SA, Subbiah V, Dumbrava EE, Karp DD, Janku F, Meric-Bernstam F, Naing A. Phase Ib trial of selinexor (SEL) in combination with nivolumab (NIVO) alone or nivolumab plus ipilimumab (NIVO+IPI) in patients (pts) with advanced malignancies: The renal cell carcinoma (RCC) experience. 2022 ASCO Annual Meeting 40(Suppl. 16), 2022. e-Pub 2022.
Piha-Paul SA, Gutierrez M, Vaccaro GM, Masood A, Brown-Glaberman U, Grilley-Olson JE, Kindler HL, Zalupski M, Heath EI, Piha-Paul SA, Zhou P, Lu H, Ansari S, Hayman J, Schmitt MW, Coveler AL. Preliminary results of a phase 1 study of sea-CD40, gemcitabine, nab-paclitaxel, and pembrolizumab in patients with metastatic pancreatic ductal adenocarcinoma (PDAC). ASCO Gastrointestinal Cancers Symposium 40(4_suppl), 2022. e-Pub 2022.
Klempner S, Strickler J, Gourley L, Jacquemont C, Bhatia V, Hunder N, Odegard V, Piha-Paul S. A Phase 1/2 study of SBT6050 combined with trastuzumab deruxtecan (T-Dxd) or trastuzumab and tucatinib with or without capecitabine in patients with Her2-expressing pr Her2-amplified cancers. SITC Annual Meeting 2021 9(Suppl 2), 2021. e-Pub 2021.
Van Cutsem E, Prenen H, Delafontaine B, Spencer K, Mitchell T, Burris H, Kotecki N, Kristeleit R, Pinato D, Sahebjam S, Graham D, Karasic T, Daniel J, O'Hayer K, Geschwindt R, Piha-Paul SA. Phase 1 Study Of INCB086550, an ORAL PD-L1 Inhibitor, In Immune-Checkpoint Naive Patients With Advanced Solid Tumors. SITC Annual Meeting 2021 9(Suppl 2), 2021. e-Pub 2021.
Riese R, Luke J, Lewis K, Janku F, Piha-Paul SA, Verschraegen C, Brennan A, Armstrong M, Varterasian M, Sokolovska A. SYNB1891, A Bacterium Engineered To Produce A Sting Agonist, Demonstrates Target Engagement In Humans Following Intratumoral Injection. SITC Annual Meeting 2021 9(Suppl 2), 2021. e-Pub 2021.
George GC, Kim AJ, Gebremeskel M, Manandhar M, Pradeep HM, Piha-Paul SA, Rodon Ahnert J, Subbiah V, Karp DD, Cleeland CS, Hong DS. Compliance with dietary guidelines and its relationship with symptoms and clinical outcomes in patients with advanced cancer in early-phase oncology clinical trials. ASCO Quality Care Symposium 39(Suppl 28), 2021. e-Pub 2021.
Johnson ML, Doi T, Piha-Paul SA, Sen S, Shimizu T, Cheng B, Yoshizuka N, Okamoto N, Okuda Y, Zian X, Serbest G, Hammett T, Brady WE, Patel MR, Bendell JC. A phase I/II multicenter, first-in-human study of DS-7300 (B7-H3 DXd-ADC) in patients (pts) with advanced solid tumors. ESMO Congress 2021 32(Suppl_5), 2021. e-Pub 2021.
Moyers J, Nguyen D, Hong DS, Ileana Dumbrava E, Fu S, Karp D, Naing A, Pant S, Janku F, Piha-Paul S, Rodon J, Subbiah V, Tsimberidou AM, Meric-Bernstam F, Yap T. Adherence to the Food and Drug Administration (FDA) Guidance for the Co-Development of Two or More Investigational New Drugs in Phase 1/2 Cancer Trials. ESMO Congress 2021 32(Suppl_5):S1105–S1106, 2021. e-Pub 2021.
Piha-Paul SA, Mahalingam D, Mulcahy MF, Kalyan A, Li H, Wu E, Kurman M, Lee S, Lin Y, Tang S, Hsiao C, Pan J, Chien S. ACE1702, a first-in-class, off-the-shelf, selected natural killer cell [oNK] product using antibody cell conjugation technology [ACC], with pre-clinical and early clinical activity in HER2 < 3+ tumors. ESMO Congress 2021 32(Suppl_5), 2021. e-Pub 2021.
Papadopoulos K, Yap TA, Piha-Paul SA, Lorusso P, Hu-Lieskovan S, Shepherd CJ, Marshall S, Holz J, Poon E, Grabowska UB, Kayitalire L. A first-in-human phase I study of FS120, an OX40/CD137 tetravalent bispecific antibody, in patients with advanced malignancies. ESMO Congress 2021 32(Suppl_5), 2021. e-Pub 2021.
Burton E, Ileana Dumbrava E, Peng W, Milton D, Amaria R, McQuade J, Glitza IC, Hong DS, Patel S, Rodon J, Yap TA, Naing A, Piha-Paul SA, Balmes G, Lazar A, Meric-Bernstam F, Hwu P, Davies MA, Tawbi HA. Ph I/II study of PI3K-β inhibitor GSK2636771 (G771) in combination with pembrolizumab (P) in patients (pts) with PTEN loss and melanoma or other advanced solid tumors. ESMO Congress 2021 32(Suppl_5), 2021. e-Pub 2021.
Klempner SJ, Beeram M, Sabanathan D, Chan A, Hamilton E, Loi S, Oh D, Emens LA, Patnaik A, Kim JE, Park YH, Odegard V, Hamke S, Jang G, Jacquemont, Hunder N, Piha-Paul. Interim results of a phase I/Ib study of SBT6050 monotherapy and pembrolizumab combination in patients with advanced HER2-expressing or amplified solid tumors. ESMO Congress 2021 32(Suppl_5), 2021. e-Pub 2021.
Calvo E, Hollebecque A, Dowlati A, Piha-Paul SA, Galvao V, Lopez J, Sehgal K, Bockorny B, Braiteh F, Peters S, Sanborn RE, Zhou P, Nazarenko N, Patnaik A. A first-in-human trial of the integrin beta-6-targeted antibody–drug conjugate, SGN-B6A, in patients with advanced solid tumors. ESMO Congress 221 32(Suppl_5), 2021. e-Pub 2021.
Coleman N, Abbot C, Somaiah N, Piha-Paul SA, Pant S, Rodon J, Call SG, Boyle S, Meric-Bernstam F, Janku F. Whole exome sequencing of tumor tissue and circulating tumor DNA in gastrointestinal stromal tumors (GIST). AACR Annual Meeting 2021 81(13 Suppl), 2021. e-Pub 2021.
Vo HH, Fu S, Hong DS, Karp DD, Piha-Paul SA, Subbiah V, Janku F, Naing A, Yap TA, Rodon Ahnert J, Ajani JA, Cartwright C, Naqvi MF, Nogueras-Gonzalez GM, Miler VA, Palmer GA, Vining DJ, Berry DA, Meric-Bernstam F, Tsimberidou AM. Initiative for Molecular Profiling and Advanced Cancer Therapy (IMPACT2): Challenges and Opportunities in Conducting an MD Anderson Randomized Study in Precision Oncology. ASCO Annual Meeting 2021 39(Suppl 15), 2021. e-Pub 2021.
Westin SN, Fu S, Tsimberidou AM, Piha-Paul SA, Akhmedzhanov F, Yilmaz B, McQuinn L, Brink AL, Gong J, Hong Leung C, Lin HY, Hong DS, Pant S, Jazaeri AA, Gershenson DM, Sood AK, Coleman RL, Shah JJ, Meric-Bernstam F, Naing A. Selinexor in combination with weekly paclitaxel in patients with advanced or metastatic solid tumors: Results of an open label, single-center, multiarm phase 1b study. ASCO Annual Meeting 2021 39(Suppl 15), 2021. e-Pub 2021.
Abo-Zahrah R, Karp DD, Adat A, Yap TA, Fu S, Rodon Ahnert J, Piha-Paul SA, Tsimberidou AM, Naing A, Subbiah V, Dumbrava EE, Overman MJ, Pradyuman Patel S, Amaria RN, Neville Westin S, Meric-Bernstam F, Janku F. Patients with advanced solid cancers treated with ERK inhibitors exhibit pseudo-progression in lymphatic nodes. ASCO Annual Meeting 2021 39(Suppl 15), 2021. e-Pub 2021.
Mettu NB, Staroudub A, Piha-Paul SA, Abdul-Karim RM, Tinoco G, Shafique MR, Smith V, Baccei C, Chun PY. Results of a phase 1 dose-escalation study of AMV564, a novel T-cell engager, alone and in combination with pembrolizumab in patients with relapsed/refractory solid tumors. ASCO Annual Meeting 2021 39(Suppl 15), 2021. e-Pub 2021.
Piha-Paul SA, Xu B, Janku F, Dumbrava EE, Fu S, Karp DD, Meric-Bernstam F, Hong DS, Rodon Ahnert J, Tsimberidou AM, Javle MM, Fan Y, Peng P, Levin WJ, Ngo B, Wang H, Sun C, Ru QC, Wu F. Phase I study of TT-00420, a multiple kinase inhibitor, as a single agent in advanced solid tumors. ASCO Annual Meeting 2021 39(Suppl 15), 2021. e-Pub 2021.
Coleman N, Naing A, Zhang S, Piha-Paul SA, Tsimberidou AM, Janku F, Rodon J, Pant S, Dumbrava EE, Fu S, Hong DS, Meric-Bernstam F, Subbiah V. Phase I study of mTORC1/2 inhibitor sapanisertib (TAK-228) in combination with metformin in patients (pts) with mTOR/AKT/PI3K pathway alterations and advanced solid malignancies. ASCO Annual Meeting 2021 39(Suppl 15), 2021. e-Pub 2021.
Yap TA, Dumbrava EE, Rodon Ahnert J, Hong DS, Pant S, Karp DD, Piha-Paul SA, Subbiah V, Tsimberidou AM, Fu S, Janku F, Montez S, Ahmad-Taha MT, Guerrero D, Nazarenko NN, Moore Y, Soth M, Kovacs J, Heffernan TP, Jones P. First-in-human biomarker-driven phase I trial of the potent and selective glutaminase-1 (GLS1) inhibitor IACS-6274 (IPN60090) in patients (pts) with molecularly selected advanced solid tumors. ASCO Annual Meeting 2021 39(15 Suppl), 2021. e-Pub 2021.
Patnaik A, Calvo E, Piha-Paul SA, Hollebecque A, Galvao V, Lopez JS, Braiteh FS, Sanborn RE, Zhou P, Nazarenko NN, Dowlati A. A phase 1 study of SGN-B6A, an antibody-drug conjugate targeting integrin beta-6, in patients with advanced solid tumors (SGNB6A-001, Trial in Progress). ASCO Annual Meeting 2021 39(Suppl 15), 2021. e-Pub 2021.
Hamid O, Liu SV, Boccia RV, Call JA, Wise-Draper TM, Alistar AT, Powderly JD, Carthon BC, Vaishampayan UN, Olszanski AJ, Wrangle JM, Shields AF, Piha-Paul SA, Desai M, Du Y, Sun L, Wang Y, Losey H, Hopkinson C, Ernstoff MC. Selection of the recommended phase 2 dose (RP2D) for subcutaneous nemvaleukin alfa: ARTISTRY-2. ASCO Annual Meeting 2021 39(Suppl 15), 2021. e-Pub 2021.
Piha-Paul SA, Bendell JC, Tolcher A, Shroff R, Pohlmann PR, Hurvitz SA, Krishnamurthy A, Pandya N, Olwill SA, Zettl M, Aviano K, Mar L, Jolicoeur P, Morales Kastresana A, Schlosser C, Bruns I, Bexon A, Ku GY. Clinical and biomarker activity of PRS-343, a bispecific fusion protein targeting 4-1BB and HER2, from a phase 1 study in patients with advanced solid tumors (Study PRS-343-PCS_04_16). AACR Annual Meeting 2021 81(13 Suppl), 2021. e-Pub 2021.
O'Sullivan Coyne G, Do KT, Kummar S, Takebe N, Piha-Paul SA, Piekarz R, Wilsker D, Miller B, Ferry-Galow K, Parchment R, Juwara L, Ong MJ, Mittra A, Doroshow JH, Chen AP. Phase I trial of the triplet berzosertib (M6620, VX-970), veliparib and cisplatin (BVP) in patients with advanced solid tumors. AACR Annual Meeting 2021 81(13 Suppl), 2021. e-Pub 2021.
Fu S, Yao S, Yuan Y, Previs RA, Elias AD, Carvajal R, George TJ, Yuan Y, Yamamura Y, Westin S, Xing Y, Ileana Dumbrava EE, Karp DD, Piha-Paul SA, Tsimberidou AM, Rodon J, Takebe N, Kunos C, Lu K, Keyomarsi K, Meric-Bernstam M. Phase II trial of the Wee1 inhibitor adavosertib in advanced refractory solid tumors with CCNE1 amplification. AACR Annual Meeting 2021 81(13 Suppl), 2021. e-Pub 2021.
Harding JJ, Cleary JM, Quinn DI, Brana I, Moreno V, Borad MJ, Loi S, Spanggaard I, Park H, Ford JM, Arnedos M, Stemmer SM, De La Fouchardiere C, Ramirez SV, Fountzilas C, Zhang J, Xu F, Lalani AS, Piha-Paul SA, Abou-Alfa GK. Targeting HER2 (ERBB2) mutation-positive advanced biliary tract cancers with neratinib: Results from the phase II SUMMIT 'basket' trial. 2021 Gastrointestinal Cancers Symposium 39(suppl 3), 2021. e-Pub 2021.
Naing A, Karp DD, Piha-Paul SA, Haymaker C, Parra ER, Yang F, Pant S, Hong DS, Fu S, Yap TA, Stephen B, Yang Y, Lin H, Hong Leung C, Daver N, Choi Y, Hajjar J, Wistuba I, Hwu PM, Meric-Bernstam M, Rodon J. Immune correlates associated with clinical outcomes in patients with advanced malignancies treated with avelumab and OX40 agonist. SITC Annual Meeting 2020 8(3), 2020. e-Pub 2020.
Powderly JD, Carthon BC, Ernstoff MS, Olszanski AJ, Wrangle JM, Shields AF, Piha-Paul SA, Curtis KK, Bidollari I, Du Y, Sun L, Putiri EL, Wang Y, Losey HC, Dezumbe B, Vaishampayan UN. Phase 1/2 study of subcutaneously administered ALKS 4230, a novel engineered cytokine, as monotherapy and in combination with pembrolizumab, in patients with advanced solid tumors: ARTISTRY-2. SITC Annual Meeting 2020 8(3 Suppl), 2020. e-Pub 2020.
Piha-Paul SA, Starodub AN, Karim R, Shafique M, Tinoco Swarez GR, Guegg C, Smith V, Chun P. Single-agent anti-tumor activity in relapsed/refractory solid tumors: interim data from the Phase 1 solid tumor trial of AMV564, a novel T-cell engager. SITC Annual Meeting 2020 8(3), 2020. e-Pub 2020.
Mitchell TC, Shaebjam S, Mehnert JM, Krasic T, O'Hayer K, Geschwindt R, Spitz S, Liu H, Bendell JC, Piha-Paul SA. Pharmacodynamic biomarkers demonstrate T-cell activation in patients treated with the oral PD-L1 inhibitor INCB086550 in a phase 1 clinical trial. SITC Annual Meeting 2020 8(3), 2020. e-Pub 2020.
Thein KZ, Tsimberidou AM, Piha-Paul SA, Janku F, Karp DD, Fu S, Zarifa A, Gong J, Yap TA, Hong DS, Subbiah V, Pant S, Meric-Bernstam F, Naing A. Selinexor in combination with carboplatin and pemetrexed (CP) in patients with advanced or metastatic solid tumors: Results of an open label, single-center, multi-arm phase Ib study. ESMO Asia Virtual Congress 31(Suppl 6):S1271, 2020. e-Pub 2020.
Thein KZ, Tsimberidou AM, Piha-Paul SA, Janku F, Karp DD, Fu S, Zarifa A, Gong J, Hong DS, Yap TA, Subbiah V, Pant S, Meric-Bernstam F, Naing A. Selinexor in combination with standard chemotherapy in patients with advanced solid tumours: Results of an open label, single-center, multi-arm phase Ib study. ESMO Asia Virtual Congress 2020 31(Suppl_6), 2020. e-Pub 2020.
Emens LA, Beeram M, Hamilton EP, Piha-Paul SA, Odegard V, Hamke S, Hunder N, Klempner SJ. A phase 1/1b study of SBT6050, a HER2-directed monoclonal antibody conjugated to a toll-like receptor 8 agonist, in subjects with advanced HER2-expressing solid tumors. SITC Annual Meeting 2020 8(3), 2020. e-Pub 2020.
Davar D, Simonelli M, Gutierrez M, Calvo E, Melear J, Piha-Paul SA, Richards D, Dallos M, Parameswaran J, Kumar V, Zhao X, Dutta S, Melero I. Interleukin-8–neutralizing monoclonal antibody BMS-986253 plus nivolumab (NIVO) in biomarker-enriched, primarily anti–PD-(L)1–experienced patients with advanced cancer: initial phase 1 results. SITC Annual Meeting 2020 8(3), 2020. e-Pub 2020.
Gouda M, Huang H, Piha-Paul S, Call SG, Karp D, Fu S, Naing A, Subbiah V, Pant S, Tsimberidou AM, Hong DS, Rodon J, Meric-Bernstam F. Circulating Tumor DNA Dynamics Predict Outcomes of Systemic Therapy in Patients with Advanced Cancers. EORTC-NCI-AACR 2020 138(Suppl 2), 2020. e-Pub 2020.
Huey R, George G, Phillips P, White R, Fu S, Janku F, Karp DD, Naing A, Piha-Paul SA, Subbiah V, Tsimberidou AM, Pant S, Yap TA, Rodon Ahnert J, Meric-Bernstam F, Shih Y-CT, Hong DS. Patient-reported out-of-pocket costs and financial toxicity during early-phase oncology clinical trials. AACR Virtual Conference: Thirteenth AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved 29(12_suppl), 2020. e-Pub 2020.
Dumbrava EI, Huang HJ, Stuckett A, Madwani K, Adat A, Hong DS, Piha-Paul S, Subbiah V, Karp D, Fu S, Naing A, Tsimberidou AM, Moulder S, Koenig K, Barcenas CH, Kee B, Fogelman D, Kopetz S, Meric-Bernstam F, Janku F. PR10 PIK3CA mutations in plasma cell-free DNA predict survival and treatment outcomes in patients with advanced cancers. AACR Special Conference on Targeting PI3K/mTOR Signaling 18(10_Suppl), 2020. e-Pub 2020.
Ku G, Bendell JC, Tolcher AW, Hurvitz SA, Krishnamurthy A, El-Khoueiry AB, Patnaik A, Shroff RT, Noonan A, Hahn NM, Matrana M, Zettl M, Aviano K, Mar L, Jolicoeur P, Olwill S, Bruns I, Piha-Paul S. A phase I dose escalation study of PRS-343, a HER2/4-1BB bispecific molecule, in patients with HER2-positive malignancies. ESMO Annual Meeting 2020 31(Suppl_4), 2020. e-Pub 2020.
Hong DS, Fogelman D Shaikh F, Dupont-Roettger D, Bisdas S, Illeana Dumbrava EE, Piha-Paul SA, liu L, Dugourd D, Yamamura Y, Fu S. A phase Ib study on a TRPV6-inhibitor, SORC13 in patients with advanced solid tumours. ESMO Virtual Congress 2020 31(Suppl_4), 2020. e-Pub 2020.
Thein KZ, Tsimberidou AM, Piha-Paul SA, Janku F, Karp DD, Fu S, Zarifa A, Gong J, Yap TA, Hong DS, Subbiah V, Pant S, Meric-Bernstam F, Naing A. Selinexor in combination with carboplatin and paclitaxel in patients with advanced or metastatic solid tumours: Results of an open label, single-center, multi-arm phase Ib study. ESMO Virtual Congress 2020 31(Suppl_4), 2020. e-Pub 2020.
Alhalabi O, Hahn AW, Msaouel P, Meric-Bernstam F, Naing A, Piha-Paul SA, Janku F, Pant S, Yap TA, Hong DS, Fu S, Karp DD, Campbell E, Campbell MT, Shah AY, Tannir N, Siefker-Radtke AO, Gao J, Roszik J, Subbiah V. Validation of prognostic scores in patients with metastatic bladder carcinoma (mBC) enrolled in early phase clinical trials. ESMO Virtual Congress 2020 31(Suppl_4), 2020. e-Pub 2020.
Thein KZ, Tsimberidou AM, Piha-Paul SA, Janku F, Karp DD, Fu S, Zarifa A, Gong J, Hong DS, Yap TA, Subbiah V, Pant S, Meric-Bernstam F, Naing A. Selinexor in combination with topotecan in patients with advanced or metastatic solid tumours: Results of an open label, single-center, multi-arm phase Ib study. ESMO Virtual Congress 2020 31(Suppl_4), 2020. e-Pub 2020.
Piha-Paul SA, Piha-Paul SA, Ileana-Dumbrava E, Ileana-Dumbrava E, Janku F, Janku F, Karp DD, Karp DD, Meric-Bernstam F, Meric-Bernstam F, Rodon J, Rodon J, Ngo B, Ngo B, Peng P, Peng P, Wu F, Wu F. Phase I study of TT-00420, a multiple kinase inhibitor, in patients with triple negative breast cancers and other advanced solid tumors. AACR Annual Meeting 2020 80(16 Suppl), 2020. e-Pub 2020.
Nusrat M, Nusrat M, Tapia C, Tapia C, Call GS, Call GS, Hong DS, Hong DS, Piha-Paul SA, Piha-Paul SA, Subbiah V, Subbiah V, Rodon J, Rodon J, Tsimberidou AM, Tsimberidou AM, Adat A, Adat A, Wang Y, Wang Y, Meric-Bernstam F, Meric-Bernstam F, Overman MJ, Overman MJ, Kopetz S, Kopetz S, Janku F, Janku F. Evaluation of cytotoxic T cell infiltration and clinical benefit from PD-L1 checkpoint inhibition among PIK3CA mutant microsatellite stable (MSS) metastatic adenocarcinoma patients. AACR Annual Meeting 2020 80(16 Suppl), 2020. e-Pub 2020.
Naing A, Karp D, Piha-Paul SA, Pant S, Subbiah V, Bodurka DC, Fu S, Jazeri AA, Kato S, Schmeler K, Nick A, Yang Y, Akhmedzhanov FO, Fessahaye S, Gong J, Stephen B, Johnson AM, Soliman PT, Sood AK, Meric-Bernstam F, Lu KH. Temsirolimus in combination with metformin in patients with advanced or refractory endometrial cancers. AACR Annual Meeting 2020 80(16 Suppl), 2020. e-Pub 2020.
Mukhtar E, Worroll D, Galletti G, Schuster S, Piha-Paul SA, Giannakakou P. Analysis of taxane drug target engagement of microtubules in circulating tumor cells from metastatic castration resistant prostate cancer patients treated with CRLX301, a nanoparticle of docetaxel. AACR Annual Meeting 2020 80(16 Suppl), 2020. e-Pub 2020.
Starodub A, Piha-Paul SA, Karim R, Ruegg C, Smith V, Chun PY. A phase I study to evaluate the T-cell engager AMV564 alone and in combination with pembrolizumab in subjects with advanced solid tumors. ASCO20 Virtual Meeting 38(15_Suppl), 2020. e-Pub 2020.
Bendell JC, Doi T, Patel MR, Piha-Paul SA, Sen S, Shimizu T, Cheng B, Mekan SF, Myobatake Y, Okuda Y, Serbest G, Johnson ML. A phase I/II, two-part, multicenter, first-in-human study of DS-7300a in patients with advanced solid malignant tumors. ASCO20 Virtual Meeting, 38(15_Suppl), 2020. e-Pub 2020.
Goldman JW, Piha-Paul SA, Curti BD, Pedersen K, Bauer TM, Groenland SL, Carvajal RD, Chhaya V, Hammond SA, Streicher K, Townsley DM, Chae YK, Voortman J, Marabelle A, Powderly JD. Safety and tolerability of MEDI0562 in combination with durvalumab or tremelimumab in patients with advanced solid tumors. ASCO20 Virtual Meeting 38(15_Suppl), 2020. e-Pub 2020.
Powderly JD, Chmielowski B, Brahmer JR, Piha-Paul SA, Bowyer SE, LoRusso P, Catenacci DVT, Wu C, Barve MA, Chisamore MJ, Nasrah N, Johnson D, Ho W. Phase I/II dose-escalation and expansion study of FLX475 alone and in combination with pembrolizumab in advanced cancer. ASCO20 Virtual Meeting 38(15_Suppl), 2020. e-Pub 2020.
Alhalabi O, Hahn AW, Meric-Bernstam F, Naing A, Piha-Paul SA, Janku F, Pant S, Yap TA, Hong DS, Fu S, Campbell E, Le H, Shah AY, Campbell MT, Tannir NM, Siefke-Radtke AO, Gao J, Roszik J, Subbiah V. Outcomes and the impact of genomic characteristics on patients with metastatic urothelial carcinoma enrolled in early phase trials. ASCO20 Virtual Meeting, 38(15_Suppl), 2020. e-Pub 2020.
Huey R, George G, Phillips P, White R, Fu S, Janku F, Karp DD, Naing A, Piha-Paul SA, Subbiah V, Tsimberidou AM, Pant S, Yap TA, Ahnert JR, Meric-Bernstam F, Shih YT, Hong DS. Patient-reported out-of-pocket costs and financial toxicity during early-phase oncology clinical trials. 2020 ASCO Annual Meeting 38(15_suppl), 2020. e-Pub 2020.
Marabelle A, Marabelle A, Cassier PA, Cassier PA, Fakih M, Fakih M, Kao SC-H, Kao SC-H, Nielsen D, Nielsen D, Italiano A, Italiano A, Guren T, Guren T, Van dongen M, Van dongen M, Spencer KR, Spencer KR, Bariani GM, Bariani GM, Ascierto PA, Ascierto PA, Santoro A, Santoro A, Hiret S, Hiret S, Ott PA, Ott PA, Piha-Paul SA, Piha-Paul SA, Liu C-C, Liu C-C, Leiby MA, Leiby MA, Norwood K, Norwood K, Delord J-P, Delord J-P. Pembrolizumab for previously treated advanced anal squamous cell carcinoma: Pooled results from the KEYNOTE-028 and KEYNOTE-158 studies. ASCO20 Virtual Meeting 38(15_Suppl), 2020. e-Pub 2020.
Hahn AW, Alhalabi O, Meric-Bernstam F, Naing A, Jonasch E, Msaouel P, Piha-Paul SA, Hong DS, Pant S, Yap TA, Campbell E, Le H, Tannir NM, Roszik J, Subbiah V. Phase I clinical trials as a therapeutic option for patients with metastatic renal cell carcinoma (mRCC). ASCO20 Virtual Meeting 38(15_Suppl), 2020. e-Pub 2020.
Guitierrez M, Guitierrez M, Long GV, Long GV, Friedman CF, Friedman CF, Richards DA, Richards DA, Corr B, Corr B, Bastos BR, Bastos BR, Uemura MI, Uemura MI, Conkling PR, Conkling PR, Moreno V, Moreno V, Edenfield WJ, Edenfield WJ, Becerra CR, Becerra CR, Piha-Paul SA, Piha-Paul SA, Peterson AC, Peterson AC, Brown M, Brown M, James LP, James LP, Zheng M, Zheng M, Jiang J, Jiang J, Kollia G, Kollia G, Swijter A, Swijter A, Ascierto PA, Ascierto PA. Anti-CTLA-4 probody BMS-986249 alone or in combination with nivolumab in patients with advanced cancers: Initial phase I results. ASCO20 Virtual Meeting 38(15_Suppl), 2020. e-Pub 2020.
Akce M, El-Khoueiry AB, Piha-Paul SA, Bacue E, Pan P, Zhang Z-Y, Ewesuedo R, Gupta D, Milton A, Judson P, O'Bryant CL. Pharmacokinetics and safety following a single oral dose of niraparib in patients with moderate hepatic impairment. ASCO20 Virtual Meeting, 38(15_Suppl), 2020. e-Pub 2020.
Gouda MA, Huang HJ, Piha-Paul SA, Call SG, Karp DD, Fu S, Naing A, Subbiah V, Pant S, Tsimberidou AM, Hong DS, Ahnert JR, Meric-Bernstam F, Janku F. Genomically informed longitudinal monitoring of circulating tumor DNA (ctDNA) predicts outcomes of cancer therapy. ASCO20 Virtual Meeting 38(15_Suppl), 2020. e-Pub 2020.
Cousin S, Blay J-Y, Garcia IB, DeBono JS, Le Tourneau C, Moreno V, Trigo JM, Hann CL, Azad A, Im S-A, Ferron-Brady G, Datta A, Wu Y, Horner T, Kremer BE, Dhar A, O'Dwyer PJ, Shapiro G, Piha-Paul SA. BET inhibitor molibresib for the treatment of advanced solid tumors: Final results from an open-label phase I/II study. ASCO20 Virtual Meeting 38(15_Suppl), 2020. e-Pub 2020.
Dowlati A, Belani CP, Simon GR, Chao H, Piha-Paul. Phase I dose escalation study of immunoconjugate L-DOS47 in combination with pemetrexed/carboplatin in non-squamous non-small cell lung cancer (NSCLC) patients. ASCO20 Virtual Meeting 38(15_Suppl), 2020. e-Pub 2020.
Colen RR, Ahmed S, Elshafeey N, Karp DD, Pant S, Piha-Paul SA, Hong DS, Yap TA, Fu S, Tsimberidou AM, Stephen B, Gong J, Rodon Ahnert J, Naing A. Radiomics to predict response to pembrolizumab in patients with advanced rare cancers. ASCO-SITC Clinical Immuno-Oncology Symposium 38(suppl 5), 2020. e-Pub 2020.
Zhao M, Zhao M, Scott S, Scott S, Evans K, Evans K, Yuca E, Yuca E, Saridogan T, Saridogan T, Demirhan ME, Demirhan ME, Kirby BP, Kirby BP, Kopetz S, Kopetz S, Diala I, Diala I, Lalani AS, Lalani AS, Piha-Paul SA, Piha-Paul SA, Meric-Bernstam F, Meric-Bernstam F. Combinatorial therapies of neratinib for HER2-amplified cancer. AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics 18(12_Suppl), 2019. e-Pub 2019.
Hegde A, Jayaprakash P, Sumner E, Nguyen D, Zain H, Piha-Paul SA, Karp D, Rodon J, Pant S, Fu S, Dumbrava E, Yap T, Subbiah V, Bhosale P, Higgins J, Williams ET, Wilson TF, Meric-Bernstam F, Curran M, Hong D. A phase 1 dose escalation study to evaluate the safety and tolerability of evofosfamide in combination with ipilimumab in advanced solid malignancies. SITC 2019 7(Suppl 1):190, 2019. e-Pub 2019.
Huey R, George G, Phillips P, White R, Fu S, Janku F, Karp DD, Naing A, Piha-Paul SA, Subbiah V, Tsimberidou AM, Pant S, Yap TA, Rodon Ahnert J, Meric-Bernstam F, Y-CT S, Hong DS. Out-of-pocket costs and financial toxicity experienced by patients in early phase clinical trials. ASCO Quality Care Symposium 37(27_Suppl), 2019. e-Pub 2019.
Naing A, Meric-Bernstam F, Karp D, Rodon JA, Piha-Paul SA, Subbiah V, Hong DS, Pant S, Fu S, Janku F, Yap TA, Tsimberidou AM, Illeana Dumbrava EE, Colen RR, Hess KR, Campbell MT, Tu S, Jimenez C, Habra MA, Varadhachary GR. Pembrolizumab in Advanced Rare Cancers. ESMO Congress 2019 30(Suppl 5), 2019. e-Pub 2019.
Marabelle A, Fakih MG, Lopez J, Shah M, Shapira-Frommer R, Nakagawa K, Chung HC, Kindler HL, Lopez-Martin JA, Miller W, Italiano A, Kao S, Piha-Paul SA, Delord J, McWilliams RR, Aurora-Garg D, Chen M, Jin F, Norwood K, Bang Y. Association of tumor mutational burden with outcomes in patients with select advanced solid tumors treated with pembrolizumab in KEYNOTE-158. ESMO Congress 2019 30(Suppl 5), 2019. e-Pub 2019.
O'Malley D, Marabelle A, De Jesus-Acosta A, Piha-Paul SA, Arkhipov A, Longo F, Motola-Kuba D, Shapira-Frommer R, Geva R, Rimel BJ, Lopez-Martin JA, Hansen AR, Mehnert JM, Chen X, Jin F, Norwood K, Ott PA. Pembrolizumab in Patients with MSI-H Advanced Endometrial Cancer from the KEYNOTE-158 Study. ESMo Congress 2019 30(Suppl 5), 2019. e-Pub 2019.
Hansen AR, Strauss J, Chaves J, Piha-Paul SA, Park H, Garralda E, Matheny CJ, Carver J, Moore A, Hug BA. A phase I, open-label study of GSK1795091 administered in combination with immunotherapies in participants with advanced solid tumours (NCT03447314). ESMO Congress 2019 30(Suppl 5), 2019. e-Pub 2019.
Tsimberidou AM, Hong DS, Fu S, Karp D, Piha-Paul SA, Kies M, Ravi V, Subbiah V, Patel S, Tu S, Janku F, Heymach J, Johnson A, Zhao L, Zhang J, Berry DA, Vining D, Futreal A, Miller VA, Meric-Bernstam F. Precision medicine: Preliminary results from the initiative for molecular profiling and advanced cancer therapy 2 (IMPACT 2) study. ESMO Congress 2019 30(Suppl 5), 2019. e-Pub 2019.
Harding J, Cleary J, Shapiro G, Braña I, Moreno V, Quinn D, Borad M, Loi S, Spanggaard I, Stemmer S, Dujka M, Cutler R, Xu F, Eli L, Macia S, Lalani A, Bryce R, Bernstam FM, Solit D, Hyman D, Piha-Paul S. Treating HER2-mutant advanced biliary tract cancer with neratinib: benefits of HER2-directed targeted therapy in the phase 2 SUMMIT 'basket' trial 30(Suppl 4):iv127, 2019. e-Pub 2019. PMID: 32085018.
Chung HC, Piha-Paul SA, Lopez-Martin J, Schellens JHM, Kao S, Jr MW, J-P D, Gao B, Planchard D, Gottfried M, Zer A, Jalal SI, Penel N, Mehnert JM, Matos I, Bennouna J, D-W K, Xu L, Krishnan S, Norwood K, Ott PA. Pembrolizumab after two or more lines of prior therapy in patients with advanced small-cell lung cancer (SCLC): Results from the KEYNOTE-028 and KEYNOTE-158 studies. Cancer Res: Proceedings of the American Association for Cancer Research Annual Meeting 2019 79(13 Suppl), 2019. e-Pub 2019.
Won HH, Selcuklu D, Piha-Paul SA, Saura C, Rodon J, Mayer IA, Loi S, Shapiro GI, Lu J, Brufsky A, Zimel C, Melcer M, Scaltriti M, Eli LD, Cutler Jr RE, Lalani AS, Bryce RP, Arteaga C, Meric-Bernstam F, Berger MF, Solit DB, Schram A, Hyman DM. Paired tumor and cfDNA in patients with HER2-mutant solid tumors treated with neratinib reveals convergence of multiple on-target resistance mechanisms: Results from the SUMMIT "Basket" Trial. Cancer Res: Proceedings of the American Association for Cancer Research Annual Meeting 2019 79(13 Suppl), 2019. e-Pub 2019.
Papadopoulos K, Eder P, Piha-Paul, SA, Gimmi C, Hussey E, Zhang S, Li L, Habermehl C, Naing A. First-in-human Phase I study of M4112, the first dual inhibitor of indoleamine 2,3-dioxygenase-1 and tryptophan 2,3-dioxygenase 2, in patients with advanced solid malignancies. Cancer Res; Proceedings of the American Association for Cancer Research Annual Meeting 2019 79(13 Suppl), 2019. e-Pub 2019.
Y-J B, Ueno M, Malka D, Chung HC, Nagrial A, Kelley RK, Piha-Paul SA, Ros W, Italiano A, Nakagawa K, Rugo HS, De Braud FG, Varga AI, Hansen AR, Gao C, Krishnan S, Norwood K, Doi T. Pembrolizumab (pembro) for advanced biliary adenocarcinoma: Results from the KEYNOTE-028 (KN028) and KEYNOTE-158 (KN158) basket studies. ASCO Annual Meeting 2019 37(15_Suppl), 2019. e-Pub 2019.
Idris T, Barghash M, Kotrotsou A, Huang HJ, Subbiah V, Kaseb AO, Piha-Paul SA, Hong DS, Meric-Bernstam F, Javle MM, Janku F, Colen RR. CT-based radiogenomic signature to identify isocitrate dehydrogenase (IDH)1/2 mutations in advanced intrahepatic cholangiocarcinoma. ASCO Annual Meeting 2019 37(15_Suppl), 2019. e-Pub 2019.
Reilley M, Tsimberidou AM, Piha-Paul SA, Yap TA, Fu S, Naing A, Rodon J, Nguyen LM, Ager C, Meng M, Jayaprakash P, Schmidt M, Baumann M, Meric-Bernstam F, Curran MA, Hong DS. Phase 1 trial of TLR9 agonist lefitolimod in combination with CTLA-4 checkpoint inhibitor ipilimumab in advanced tumors. ASCO Annual Meeting 20219 37(15_Suppl), 2019. e-Pub 2019.
Uboha NV, Milhem MM, Kovacs C, Amin A, Magley A, Purkayastha DD, Piha-Paul SA. Phase II study of spartalizumab (PDR001) and LAG525 in advanced solid tumors and hematologic malignancies. ASCO Annual Meeting 2019 37(15_Suppl), 2019. e-Pub 2019.
Piha-Paul SA, Wan Q, Xiong W, Peng P, Yang X, Wu H, Ngo B, Wu F. A phase I, first-in-human, dose-escalation and dose-expansion study of the multitarget kinase inhibitor TT-00420 in patients with advanced solid tumors. ASCO Annual Meeting 2019 37(15_Suppl), 2019. e-Pub 2019.
Mittra A, O'Sullivan Coyne GH, Do KT, Piha-Paul SA, Kummar S, Takebe N, Bruns A, Juwara L, Rubinstein L, Hogu M, Kinders RJ, Parchment RE, Miller B, Wilsker D, Monge B CM, Khan SH, Doyle LA, Doroshow JH, Chen AP. Safety and tolerability of veliparib, an oral PARP inhibitor, and M6620 (VX-970), an ATR inhibitor, in combination with cisplatin in patients with refractory solid tumors. ASCO Annual Meeting 2019 37(15_Suppl), 2019. e-Pub 2019.
Yap TA, Rodon Ahnert J, Piha-Paul SA, Fu S, Janku F, Karp DD, Naing A, Ileana Dumbrava EE, Pant S, Subbiah V, Tsimberidou AM, Hong DS, Rose KM, Xu Q, Vellano CP, Mahendra M, Jones P, Di Francesco ME, Marszalek JR, Meric-Bernstam F. Phase I trial of IACS-010759 (IACS), a potent, selective inhibitor of complex I of the mitochondrial electron transport chain, in patients (pts) with advanced solid tumors. ASCO Annual Meeting 2019 37(15_Suppl), 2019. e-Pub 2019.
Patel SP, Pelster M, Mostorino R, Wolff JE, Ramathal C, Chen X, Hu B, Piha-Paul SA. Cell-free DNA in uveal melanoma: Results from the first-in-human trial of mivebresib (ABBV-075). ASCO Annual Meeting 2019 37(15_Suppl), 2019. e-Pub 2019.
Huey R, George G, Phillips P, White R, Fu S, Janku F, Karp DD, Naing A, Piha-Paul SA, Subbiah V, Tsimberidou AM, Pant S, Yap TA, Ahnert JR, Meric-Bernstam F, Shih Y-CT, Hong DS. Out of pocket costs and financial toxicity experienced by patients in early phase clinical trials. ASCO Annual Meeting 2019 37(Suppl), 2019. e-Pub 2019.
Smyth LM, Saura C, Piha-Paul SA, Lu J, Mayer IA, Brufsky AM, Spanggaard I, Arnedos M, Cutler RE, Hyman. Update on the phase II SUMMIT trial: Neratinib + fulvestrant for HER2-Mutant, HR-positive, metastatic breast cancer. ESMO Breast Cancer 2019 Conference 30(Suppl 3), 2019. e-Pub 2019.
Smyth LM, Piha-Paul SA, Saura C, Loi S, Lu J, Shapiro GI, Juric D, Mayer IA, Arteaga C, de la Fuente M, Brufsky AM, Mau-Sorensen M, Arnedos M, Moreno V, Sohn J-H, Schwartzberg L, Gonzàlez-Farré, Cervantes A, Mann G, Shahin S, Cutler R, Jr, Eli LD, Xu F, Bagulho T, Lalani AS, Bryce R, Solit DB, Hyman DM, Meric-Bernstam F, Baselga J. Neratinib + fulvestrant for HER2-mutant, HR-positive, metastatic breast cancer: Updated results from the phase 2 SUMMIT trial. Cancer Research; Proceedings of the 2018 San Antonio Breast Cancer Symposium 79(4 Suppl), 2019. e-Pub 2019.
Strosberg JR, Mizuno N, Doi T, Grande E, J-P D, Shapira-Frommer R, Bergsland EK, Shah MH, Fakih M, Takashashi S, Piha-Paul SA, O'Neil B, Thomas S, Lolkema MP, Wang JD, Ibrahim N, Pruitt SK, Hadoux J. Pembrolizumab treatment of advanced neuroendocrine tumors: Results from the phase II KEYNOTE-158 study. 2019 Gastrointestinal Cancers Symposium 37(Suppl 4), 2019. e-Pub 2019.
Pant S, Subbiah V, Rodon J, Janku F, Hong D, Karp D, Piha-Paul S, Tsimberidou AM, Naing A, Fu S, Savage RE, Chai F, Yu Y, Tith K, Alfattal R, Schwartz B, Meric-Bernstam F, Yap T. A phase I dose escalation study of ARQ 751 in adult patients with advanced solid tumors with AKT1, 2, 3 genetic alterations, activating PI3K mutations, PTEN-null, or other known actionable PTEN mutations. 30th EORTC-NCI-AACR Molecular Targets and Cancer Therapeutics 103(S1), 2018. e-Pub 2018.
Ferrarotto R, Glisson B, Blumenschein G, Hong D, Piha-Paul S, Rodon Ahnert J, Pant S, Tsimberidou A, Janku F, Alshawa A, Jain D, Rejon M, Hess K, Colen R, Lu C, Stephen B, Tapia C Mendoza T, Meric-Bernstam F, Naing A. Efficacy of pembrolizumab in patients with cutaneous squamous cell carcinoma. 30th EORTC-NCI-AACR Symposium Abstract Book 103(S1), 2018. e-Pub 2018.
Ahmed S, Elshafeey N, Huang HJ, Madwani K, Fu S, Tsimberidou AM, Piha-Paul SA, Naing A, Hong D, Karp DD, Cabrilo G, Kopetz S, Subbiah V, Kee BK, Eng C, Morris VK, Meric-Bernstam F, Colen R, Janku F. Circulating tumor cell-free DNA correlates with the total tumor volume and survival in patients with advanced cancers. 30th EORTC-NCI-AACR Molecular Targets and Cancer Therapeutics Symposium 103(S1), 2018. e-Pub 2018.
Reilley MJ, Ager C, Meng M, Tsimberidou AM, Piha-Paul SA, Yap TA, Fu S, Naing A, FACP, Rodon J, Nguyen L, Bhosale P, Schmidt M, Baumann M, Meric-Bernstam F, Curran MA, Hong D. Combination of subcutaneously administered TLR9 agonist lefitolimod with CTLA-4 checkpoint inhibitor ipilimumab - A phase I trial in patients with advanced solid tumors. SITC 33rd Annual Meeting 2018, 2018. e-Pub 2018.
Reilley M, Ager C, Meng M, Tsimberidou AM, Piha-Paul SA, Yap T, Fu S, Naing A, Rodon J, Nguyen L, Bhosale P, Schmidt M, Baumann M, Meric-Bernstam F, Curran M, Hong DS. Combination of subcutaneously administered TLR9. SITC Annual Meeting 2018 6(Suppl 1), 2018. e-Pub 2018.
Pant S, Subbiah V, Rodon J, Janku F, Hong DS, Karp D, Piha-Paul SA, Tsimberidou AM, Naing A, Fu S, Savage RE, Chai F, Yu Y, Schwartz B, Meric-Bernstam F, Yap T. Results of a phase I dose escalation study of ARQ 751 in adult subjects with advanced solid tumors with AKT1, 2, 3 genetic alterations, activating PI3K mutations, PTEN-null, or other known actionable PTEN mutations. AACR Annual Meeting 2018 78(13 Suppl), 2018. e-Pub 2018.
O'Sullivan Coyne GH, Do KT, Kummar S, Takebe N, Flanagan Quinn M, Piha-Paul SA, Bruns A, Juwara L, Sharon E, Piekarz R, Streicher H, Rubinstein L, Wilsker D, Kinders RJ, Parchment RE, Levy EB, Doyle A, Doroshow JH, Chen AP. Phase I trial of the triplet M6620 (formerly VX970) + veliparib + cisplatin in patients with advanced solid tumors. ASCO Annual Meeting 2018 36(15_Suppl), 2018. e-Pub 2018.
Tsimberidou AM, Hong DS, Wheler JJ, Falchook GS, Naing A, Fu S, SA <, Janku F, Cartwright C, Broaddus R, Nogueras-Gonzalez GM, Hwu P, Kurzrock R. Precision medicine: Clinical outcomes including long-term survival according to the pathway targeted and treatment period—The IMPACT study. ASCO Annual Meeting 2018 36(15_Suppl), 2018. e-Pub 2018.
Carleton M, Powers J, Phillips P, Beg MS, Lee JJ, Rahma OE, Piha-Paul SA, Lee E, HestirK, Xu K, Pandya D, Inamdar SP, Perna SK, S-MA H, Waingerg ZA. Pharmacodynamics (PD) and genomic profiling of pts treated with cabiralizumab (cabira) + nivolumab (NIVO) provide evidence of on-target tumor immune modulations and support future clinical applications. ASCO Annual Meeting 2018 36(15_Suppl), 2018. e-Pub 2018.
Piha-Paul SA, Piha-Paul SA, Amin A, Amin A, Kovacs C, Kovacs C, Magley A, Magley A, Purkayastha DD, Purkayastha DD, Zhuo Y, Zhuo Y. A phase 2, open-label study of the combination of spartalizumab (PDR001) and LAG525 for patients with advanced solid tumors and hematologic malignancies. ASCO Annual Meeting 2018 36(15_Suppl), 2018. e-Pub 2018.
Piha-Paul SA, Sachdev JC, Barve MA, LoRusso P, Zelig Szmulewitz R, Patel SP, McKee MD, Wolff JE, Hu B, Sood A, Chen X, Wilson SC, O'Neil BH. Results of the first-in-human study of ABBV-075 (mivebresib), a pan-inhibitor of bromodomain (BD) and extra terminal (BET) proteins, in patients (pts) with relapsed/refractory (R/R) solid tumors. ASCO Annual Meeting 2018 36(15_Suppl), 2018. e-Pub 2018.
Kheder E, Hess KR, Xing Y, Cortez MA, Subbiah V, Janku F, Fu S, Naing A, Karp DD, Piha-Paul SA, Yap TA, Pant S, Rodon Ahnert J, Tawbi HA, Welsh JW, Meric-Bernstam F, Hong DS. TP53 mutations and programmed cell death ligand-1 expression in solid tumors: Associations with clinical factors and outcomes. ASCO Annual Meeting 2018 36(15_Suppl), 2018. e-Pub 2018.
Piha-Paul SA, Fu S, Hong DS, Janku F, Karp DD, Naing A, Pant S, Rodon Ahnert J, Subbiah V, Tsimberidou AM, Yap TA, Meric-Bernstam F. Phase I study of the pan-HER inhibitor neratinib given in combination with everolimus, palbociclib or trametinib in advanced cancer subjects with EGFR mutation/amplification, HER2 mutation/amplification or HER3/4 mutation. ASCO Annual Meeting 2018 36(15_Suppl), 2018. e-Pub 2018.
Fountzilas E, Krishnan E, Janku F, Fu S, Karp DD, Naing A, Subbiah V, Hong DS, Piha-Paul SA, Vining DJ, Tsimberidou AM. A phase I clinical trial of hepatic arterial infusion of oxaliplatin and oral capecitabine, with or without systemic bevacizumab, for patients with advanced cancer and liver involvement. ASCO Annual Meeting 2018 36(15_Suppl), 2018. e-Pub 2018.
George G, Mendoza TR, Iwuanyanwu EC, Shi Q, Piha-Paul SA, Williams LA, Karp DD, Naing A, Janku F, Bokhari RH, Wang SX, Hong DS, Cleeland CS. Longitudinal patient-reported symptom severity and symptom interference with activity-related and mood-related functioning and survival in patients with advanced cancer on early-phase clinical trials of immunotherapeutic or targeted agents. ASCO Annual Meeting 2018 36(15_Suppl), 2018. e-Pub 2018.
Chung HC, Schellens JHM, J-P D, Perets R, Italiano A, Shapira-Frommer R, Manzuk L, Piha-Paul SA, Wang J, Zeigenfuss S, Pruitt SK, Marabelle A. Pembrolizumab treatment of advanced cervical cancer: Updated results from the phase 2 KEYNOTE-158 study. ASCO Annual Meeting 2018 36(15_Suppl), 2018. e-Pub 2018.
O'Neil BH, Modi D, LoRusso P, Wong S, Motwani M, Sachdeve JC, Wolff JE, Patel SP, Hu B, Zelig Szmulewitz R, Sood A, Barve MA, McKee MD, Piha-Paul SA. Gene expression and cytokine modulation in a first in human (FIH) study of a pan BET inhibitor ABBV-075 in solid tumors. ASCO Annual Meeting 2018 36(15_Suppl), 2018. e-Pub 2018.
Chung HC, Lopez-Martin JA, Chuan-Hao Kao S, Miller WH, Ros W, Gao B, Marabelle A, Gottfried M, Zer A, Delord J-P, Penel N, Jalal SI, Xu L, Zeigenfuss S, Pruitt SK, Piha-Paul SA. Phase 2 study of pembrolizumab in advanced small-cell lung cancer (SCLC): KEYNOTE-158. ASCO Annual Meeting 2018 36(15_Suppl), 2018. e-Pub 2018.
Groisberg R, Hess KR, Hong DS, Heymach J, Naing A, Piha-Paul SA, Janku F, Javel MM, I-N HM, Conley AP, Meric-Bernstam F, Subbiah V. Outcomes of patients with gene fusion driven cancers treated on early phase clinical trials. ASCO Annual Meeting 2018 36(15_Suppl), 2018. e-Pub 2018.
Meric-Bernstam F, Beeram M, Mayordomo JI, Hanna DL, Ajani JA, Blum Murphy MA, Murthy RK, Piha-Paul SA, Mauer TM, Bendell JC, El-Khoueiry AB, Lenz H-J, Press MF, Royer N, Hausman DF. Single agent activity of ZW25, a HER2‑targeted bispecific antibody, in heavily pretreated HER2‑expressing cancers. ASCO Annual Meeting 2018 36(15_Suppl), 2018. e-Pub 2018.
Patel SP, Patel SP, Wolff JE, Wolff JE, Mostorino RM, Mostorino RM, Chen X, Chen X, McKee MD, McKee MD, Piha-Paul SA, Piha-Paul SA. Uveal melanoma patients (pts) treated with abbv-075 (mivebresib), a pan-inhibitor of bromodomain and extraterminal (BET) proteins: Results from a phase 1 study. ASCO Annual Meeting 2018 36(15_Suppl), 2018. e-Pub 2018.
Hamilton E, Meric-Bernstam F, Infante J, Murthy R, Patnaik A, Piha-Paul SA, Tolcher A, Hausman D, Royer N, Beeram M. Phase 1 dose escalation with ZW25, a HER2-targeted bispecific antibody, in patients (pts) with HER2-high breast cancer (BC). SABCS 2018 78(4_Suppl), 2018. e-Pub 2018.
Alshawa A, Alshawa A, Fujii T, Fujii T, Abu Sbeih H, Abu Sbeih H, Blechacz B, Blechacz B, Bilen MA, Bilen MA, Hess KR, Hess KR, Suarez-Almazor ME, Suarez-Almazor ME, Hong DS, Hong DS, Tsimberidou AM, Tsimberidou AM, Gong J, Gong J, Stephen B, Stephen B, Subbiah V, Subbiah V, Piha-Paul SA, Piha-Paul SA, Fu S, Fu S, Mendoza TR, Mendoza TR, Thirumurthi S, Thirumurthi S, Meric-Bernstam F, Meric-Bernstam F, Naing A, Naing A, Miller E, Miller E. Hepatotoxicity in advanced cancer patients receiving immune-based cancer treatment. 2018 ASCO-SITC Immuno-Oncology Symposium 36(5_Suppl), 2018. e-Pub 2018.
Falchook GS, Talpaz M, Mita M, Szmulewitz R, Piha-Paul S, Harb W, Morgensztern D, Kaplan J, Munster P, Cornell RF, Zheng F, Yeleswaram S, Zhou G, Cassaday R. Phase 1/2 study of INCB054329, a bromodomain and extraterminal (BET) protein inhibitor, in patients (pts) with advanced malignancies. AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics 17(1 Suppl), 2018. e-Pub 2018.
Ileana Dumbrava E, Ileana Dumbrava E, Balaji K, Balaji K, Raghav K, Raghav K, Javle M, Javle M, Blum-Murphy M, Blum-Murphy M, Sajan B, Sajan B, Kopetz S, Kopetz S, Boraddus R, Boraddus R, Routbort M, Routbort M, Pant S, Pant S, Tsimberidou A, Tsimberidou A, Subbiah V, Subbiah V, Hong DS, Hong DS, Rodon Ahnert J, Rodon Ahnert J, Shaw K, Shaw K, Piha-Paul SA, Piha-Paul SA, Meric-Bernstam F, Meric-Bernstam F. Targeting HER2 (ERBB2) amplification identified by next-generation sequencing (NGS) in patients with advanced or metastatic solid tumors. AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics 17(1 Suppl), 2018. e-Pub 2018.
Piha-Paul SA, Xiong WW, Moss T, Mostorino RM, Sedelmeier S, Hess K, Fu S, Hong DS, Janku F, Karp D, Naing A, Pant S, Rodon J, Subbiah V, Tsimberidou AM, Yap T, Javle M, Tapia C, Shaw KR, Eterovic K, Mills GB, Meric-Bernstam F. Phase II study of the PARP inhibitor talazoparib in advanced cancer patients with somatic alterations in BRCA1/2, mutations/deletions in PTEN or PTEN loss, aberrations in other BRCA pathway genes, and germline mutations in BRCA1/2 (not breast or ovarian cancer). AACR-NCI EORTC International Conference on Molecular Targets and Cancer Therapeutics 17(1 Suppl), 2018. e-Pub 2018.
Zhao M, Scott S, Evans K, Yuca E, Murthy R, Avogadri-Connors F, Cutler R, Lalani AS, Piha-Paul S, Meric-Bernstam F. Exploring optimal targeted combination therapies with neratinib for HER2 breast cancer. AACR Annual Meeting 2017 77(13_Suppl), 2017. e-Pub 2017.
Sen S, Hess K, Hong D, Naing A, Piha-Paul S, Janku F, Fu S, Liu H, Jiang Y, Khanji R, Karp D, Tsimberidou A, Tannier N, Meric-Bernstam F, Subbiah V. Development of a novel prognostic scoring system for patient selection in immune checkpoint inhibitor phase I clinical trials. AACR Annual Meeting 2017 77(19), 2017. e-Pub 2017.
Hyman DM, Piha-Paul SA, Rodon J, Saura C, Shapiro GI, Quinn DI, Moreno V, Mayer IA, Arteaga C, Boni V, Calvo E, Loi S, Lockhart AC, Smyth LM, Erinjeri J, Scaltriti M, Ulaner G, Torris J, Patel J, Tang J, Meng F, Selcuklu D, Won H, Boluvier N, Berger MF, Jr CR, Xu F, Butturini A, Eli SD, Mann G, Lalani AS, Bryce RP, Meric-Bernstam F, Baselga J, Solit DB. Neratinib in HER2 or HER3 mutant solid tumors: SUMMIT, a global, mulit-histology, open-label, phase 2 'basket' study. AACR Annual Meeting 2017 77(19), 2017. e-Pub 2017.
Kheder E, Huang HJ, Wu A, Hong DS, Piha-Paul SA, Karp DD, Fu S, Subbiah V, Tsimberidou AM, Naing A, Diab A, Javle M, Kopetz S, Sood AK, Kurie JM, Meric-Bernstam F, Gleeson M, Janku F. Detection of circulating antibodies against KRAS in patients with advanced cancers. AACR Annual Meeting 2017 77(19), 2017. e-Pub 2017.
Sakamuri D, Kato S, Huang HJ, Naing A, Holley VR, Patel S, Piha-Paul SA, Tsimberidou AM, Hong DS, Meric-Bernstam F, Janku F. Dose escalation study of vemurafenib with crizotinib or sorfenib in patients with BRAF-mutated advance cancers. ESMO 2017 Congress 28(Suppl 5), 2017. e-Pub 2017.
Jassowicz A, Liu L, Huang H, Hong DS, Naing A, Subbiah V, Piha-Paul SA, Toung J, Vijayaraghavan R, Zhang R, Kang H, Fu S, Tsimberidou AM, Lu C, Eng C, Moulder S, Kopetz S, Amaria R, Meric-Bernstam F, Janku F. Targeted methylation sequencing of plasma cell-free DNA identifies patients with advanced breast, colorectal, non-small cell lung cancer, melanoma with poor outcomes. ESMO 2017 Congress 28(Suppl 5), 2017. e-Pub 2017.
Beeram M, Hamilton E, Blum Murphy M, Hausman D, Infante JR, Korn R, Patnaik A, Piha-Paul SA, Rasco D, Rowse G, Thimmarayappa J, Tolcher A, Meric-Bernstam F. Phase 1 dose-escalation study of single-agent ZW25, a HER2-targeted bispecific antibody, in patients (pts) with HER2-expressing cancers. ESMO 2017 Congress 28(Suppl 5), 2017. e-Pub 2017.
Mehnert JM, Rugo HS, O'Neil BH, Santoro A, Schellens JHM, Cohen RB, Doi T, Ott PA, Pishvaian MJ, Puzanov I, Aung KL, Hsu C, Le Tourneau C, Soria J-C, Elez E, Tamura K, Gould M, Zhao G, Stein K, Piha-Paul SA. Pembrolizumab for patients with PD-L1-positive advanced carcinoid or pancreatic neuroendocrine tumors: Results from the KEYNOTE-028 study. ESMO 2017 Congress 28(Suppl 5), 2017. e-Pub 2017.
Ott PA, Bang Y-J, Razak ARA, Bennouna J, Soria J-C, Rugo HS, Cohen RB, O'Neil BH, Mehnert JM, Lopez J, Doi T, van Brummelen E, Levitan D, Zhao G, Emancipator K, Stein K, Joe A, Ayers M, Lunceford J, Piha-Paul SA. Relationship of PD-L1 and T-cell inflamed gene expression profile (GEP) to clinical response in a multicohort trial of solid tumors (KEYNOTE [KN] 028). ESMO 2017 Congress 28(Suppl 5), 2017. e-Pub 2017.
Parseghian C, Patnana M, Bhosale P, Hess K, Kopetz S, Overman M, Naing A, Piha-Paul S, Subbiah V, Hong D, Le H, Pant S. Evaluating for pseudoprogression in colorectal and pancreatic tumors treated with immunotherapy. ESMO World Congress on Gastrointestinal Cancer 2017 28(Suppl 3), 2017. e-Pub 2017.
Piha-Paul SA, Piha-Paul SA, Sharma S, Sharma S, Shih C, Shih C, O'Neil BH, O'Neil BH, Zhou Q, Zhou Q, Yu T, Yu T. A phase I study of the tolerability, safety, pharmacokinetics and preliminary antitumor effects of KBP-5209, a novel pan-HER inhibitor, in patients with advanced solid tumors. 2017 ASCO Annual Meeting 35(15_suppl), 2017. e-Pub 2017.
Tsimberidou AM, Hong DS, Cartwright C, Wheler JJ, Falchook GS, Naing A, Fu S, Piha-Paul SA, Janku F, Hwu P, Kee BK, Kies MS, Broaddus R, Mendelsohn J, Hess KR, Kurzrock R, Authors A. Initiative for Molecular Profiling and Advanced Cancer Therapy (IMPACT): An MD Anderson precision medicine study. 2017 ASCO Annual Meeting 35(15_suppl), 2017. e-Pub 2017.
Naing A, Lopez-Berestein G, Fu S, Tsimberidou AM, Pant S, Piha-Paul SA, Janku F, Hong DS, Sulovic S, Meng X, Jazaeri AA, Ng CS, Karp DD, Subbiah V, Meric-Bernstam F, Mitra R, Wu S, Sood A, Coleman RL. EphA2 gene targeting using neutral liposomal small interfering RNA (EPHARNA) delivery: A phase I clinical trial. 2017 ASCO Annual Meeting I 35(15_suppl), 2017. e-Pub 2017.
Naing A, Fu S, Tsimberidou AM, Pant S, Piha-Paul SA, Janku F, Hong DS, Colen RR, Carter BW, Evans E, Tawbi HAH, Karp DD, Subbiah V, Dev R, Hess KR, Ueno NT, Simon GR, Overman MJ, Coleman RL, Meric-Bernstam F. Phase IB study to evaluate the safety of selinexor in combination with multiple standard chemotherapy agents in patients with advanced malignancies. 2017 ASCO Annual Meeting 35(15_suppl), 2017. e-Pub 2017.
Sen S, Sen S, Piha-Paul SA, Piha-Paul SA, Kato S, Kato S, Karp DD, Karp DD, Janku F, Janku F, Fu S, Fu S, Pant S, Pant S, Tsimberidou AM, Tsimberidou AM, Subbiah V, Subbiah V, Kurzrock R, Kurzrock R, Meric-Bernstam F, Meric-Bernstam F, Hong DS, Hong DS. Phase I study of nab-paclitaxel, gemcitabine, and bevacizumab in advanced cancers. 2017 ASCO Annual Meeting 35(15_suppl), 2017. e-Pub 2017.
Dumbrava EEI, Brusco L, Daniels MS, Wathoo C, Shaw KR, Lu KH, Zheng X, Strong LC, Keating Litton J, Arun B, Eterovic AK, Routbort M, Piha-Paul SA, Subbiah V, Hong DS, Kopetz S, Mendelsohn Mills GB, Chen K, Meric-Bernstam F. Prevalence of incidental germline pathogenic (PV) and likely pathogenic (LPV) variants in hereditary cancer-related genes identified in matched tumor/normal sequencing of advanced solid tumors. 2017 ASCO Annual Meeting 35(15_suppl), 2017. e-Pub 2017.
Maitland ML, Sharma M, Zhao B, McKee MD, Karovic S, Thomeas V, McIver M, Yang H, Piha-Paul SA, Falchook GS, Karrison T, Kurzrock R, Janish LA, Hoening E, Wong S, Munasinghe W, Ansell PJ, Ratain MJ, Schwartz LH, Hong DS. Pharmaco-kinetics/dynamics (PK/PD) evaluation and individual patient cross-over studies with growth trajectory assessment to adaptively develop ilorasertib. 2017 ASCO Annual Meeting 35(15_suppl), 2017. e-Pub 2017.
Varadhachary GR, Singh Raghav KP, Pant S, Janku F, Fu S, Hong DS, Piha-Paul SA, Colen RR, Subbiah V, Painter J, Tsimberidou AM, Stephen B, Karp DD, McQuinn L, Mendoza TR, Hess KR, Meric-Bernstam F, Naing A. Phase II study for the evaluation of efficacy of pembrolizumab (MK-3475) in patients with cancer of unknown primary. 2017 ASCO Annual Meeting 35(15_suppl), 2017. e-Pub 2017.
Piha-Paul SA, Hierro C, Boni V, Moreno V, Hahn NM, Bitting RL, Bauer TM, Aggarwal RR, Gourlay S, Smith P, Venetsanakos E, Meric-Bernstam F, Brameld K, Karr D, Tabernero J. A phase 1, multicenter, dose-escalation study of PRN1371, an irreversible covalent FGFR1-4 kinase inhibitor, in patients with advanced solid tumors, followed by expansion cohorts in patients with FGFR genetic alterations. 2017 ASCO Annual Meeting I 35(15_suppl), 2017. e-Pub 2017.
Meric-Bernstam F, Beeram M, Blum MA, Hausman DF, InfanteJR, Patnaik A, Piha-Paul SA, Rasco DW, Rowse G, Thimmarayappa J, Tolcher AW, Hamilton EP. Phase 1 dose escalation of ZW25, a HER2-targeted bispecific antibody, in patients (pts) with HER2-expressing cancers. 2017 ASCO Annual Meeting 35(15_suppl), 2017. e-Pub 2017.
Moehrmann L, Huang HJ, Hong DS, Tsimberidou AM, Fu S, Piha-Paul SA, Subbiah V, Karp DD, Naing A, Krug A, Enderle D, Priewasser T, Noerholm M, Eng C, Kopetz S, Skog J, Meric-Bernstam F, Janku F. Liquid biopsies of plasma exosomal nucleic acids, plasma cell-free DNA, and survival of patients with advanced cancers. 2017 ASCO Annual Meeting I 25(15_suppl), 2017. e-Pub 2017.
Dumbrava EEI, Brusco L, Daniels MS, Wathoo C, Shaw KR, Lu KH, Zheng X, Strong LC, Keating Litton J, Arun B, Eterovic AK, Piha-Paul SA, Subbiah V, Hong DS, Woodman SE, Mendelsohn J, Yap TA, Mills GB, Chen K, Meric-Bernstam F. Pathogenic variants in DNA damage response (DDR) genes in patients with advanced solid tumors. 2017 ASCO Annual Meeting 35(15_suppl), 2017. e-Pub 2017.
Varga A, Piha-Paul SA, Ott PA, Mehnert JM, Berton-Rigaud D, Morosky A, Zhao GQ, Rangwala RA, Matei D. Pembrolizumab in patients (pts) with PD-L1–positive (PD-L1+) advanced ovarian cancer: Updated analysis of KEYNOTE-028. 2017 ASCO Annual Meeting 35(15_suppl), 2017. e-Pub 2017.
Groisberg R, Subbiah V, Hong D, Janku F, Piha-Paul S, Naing A, Benjamin R, Putal SK, Somaiah N, Conley A. Characteristics and outcomes of patients with advanced sarcoma enrolled in early phase immunotherapy trials. AACR Annual Meeting 2017 77(13_Suppl), 2017. e-Pub 2017.
Janku F, Barzi A, Sartore-Bianchi A, Fujii T, Cassingena A, Siravegna G, Karp DD, Piha-Paul SA, Subbiah V, Tsimberidou AM, Huang HJ, Veronese S, Di Nicolantonio F, Erlander MG, Luthra R, Kopetz S, Meric-Bernstam F, Siena S, Lenz H-J, Bardelli A. Mutation enrichment next-generation sequencing for quantitative detection of KRAS mutations in urine cell-free DNA from patients with advanced colorectal and other cancers. 2017 Gastrointestinal Cancers Symposium 35(Suppl 4S), 2017. e-Pub 2017.
Dembla V, Ray D, Lockett P, Fullmer C, Subramanian H, Subbiah V, Fu S, Janku F, Tsimberidou AM, Naing A, Piha-Paul SA, Hong DS, Pant S, Miller VA, Lim J, Le H, Karp DD. Drug development in the MD Anderson Cancer Center (MDACC) Clinical Translational Research Center (CTRC) - 2011-2015: The challenge of precision medicine in a very broad playing field. 28th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics 68(Suppl 1), 2016. e-Pub 2016.
Fujii T, Colen R, Bilen M, Hess K, Jajjar J, Suarez-Almazor M, Alshawa A, Hong D, Stephen B, Janku F, Subbiah V, Kato S, Karp D, Piha-Paul S, Tsimberidou A, Fu S, Sharma P, Meric-Bernstam F, Naing A. Incidence of immune-related adverse events in patients who received immunotherapy and radiographic analysis to predict pneumonitis. 28th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics 68(Suppl 1), 2016. e-Pub 2016.
George G, George G, Buford A, Buford A, Hess K, Hess K, Piha-Paul S, Piha-Paul S, Zinner R, Zinner R, Subbiah V, Subbiah V, Iwuanyanwu E, Iwuanyanwu E, Cleeland C, Cleeland C, Meric-Bernstam F, Meric-Bernstam F, Bernstam E, Bernstam E, Hong D, Hong D. Cancer-related internet use in patients with advanced cancer in a phase I clinical trials clinic. 28th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics 68(Suppl 1), 2016. e-Pub 2016.
Ayers M, Lunceford J, Nebozhyn M, Murphy E, Loboda A, Kaufman DR, Albright A, Cheng J, Kange PS, Shankaran V, Piha-Paul SA, Yearley J, Seiwert T, Ribas A, McClanahan TK. An immune-related gene expression profile delineates features of the tumor microenvironment required for clinical response to PD-1 blockade. 31st Annual Meeting of the SITC 2016 4(Suppl 1):48, 2016. e-Pub 2016.
Wang H, Markman B, De Souza P, Dees EC, Gangadhar TC, Piha-Paul SA, Zamboni WC, Murphy C, Senderowicz. A dose-escalation study of weekly intravenous CRLX301 in patients with advanced solid tumor malignancies. 41st ESMO Congress 2016 27(Suppl 6), 2016. e-Pub 2016.
Wang H, Zamboni W, Tolcher A, Lakhani N, Piha-Paul SA, Caliri K, Crowell T, Senderowicz A. Pharmacokinetics (PK) of CRLX101 administered weekly in patients (pts) with advanced solid tumors. 41st ESMO Congress 2016 27(Suppl 6), 2016. e-Pub 2016.
Lakhani N, Piha-Paul SA, Senderowicz A, Caliri K, Crowell T, Wang H Tolcher A. Evaluation of weekly dosing of CRLX101 alone and in combination with bevacizumab (bev) in patients (pts) with advanced solid tumors. 41st ESMO Congress 2016 27(Suppl 6), 2016. e-Pub 2016.
Hansen A, Massard C, Ott PA, Haas N, Lopez J, Ejadi S, Wallmark J, Keam B, Delord J, Aggarwal R, Gould M, Qiu P, Saraf S, Keefe S, Piha-Paul S. Pembrolizumab for patients with advanced prostate adenocarcinoma: Preliminary results from the KEYNOTE-028 study. 41st ESMO Congress 27(Suppl 6), 2016. e-Pub 2016.
Fujii T, Vibat CR, Karp DD, Piha-Paul SA, Subbiah V, Tsimberidou AM, Fu S, Hong DS, Huang HJ, Madwani K, Andrews DL, Hancock S, Naing A, Luthra R, Kee BK, Kopetz S, Erlander MG, Melnikova V, Meric-Bernstam F, Janku F. Circulating tumor DNA assay performance for detection and monitoring of KRAS mutations in urine from patients with advanced cancers. AACR 107th Annual Meeting 76(14 Suppl), 2016. e-Pub 2016.
O'Dwyer PJ, Piha-Paul SA, French C, Harward S, Ferron-Brady G, Wu Y, Barbash O, Wyce A, Annan M, Horner T, Parr NJ, Prinjha RK, Carpenter C, Shapiro G, Dhar A, Hann C. GSK525762, a selective bromodomain (BRD) and extra terminal protein (BET) inhibitor: results from part 1 of a phase I/II open-label single-agent study in patients with NUT midline carcinoma (NMC) and other cancers. AACR 107th Annual Meeting 76(14 Suppl), 2016. e-Pub 2016.
Madwani K, Huang HJ, Shelton DN, Fu S, Tsimberidou AM, Piha-Paul SA, Naing A, Hong DS, Karp DD, Andrews DL, Cabrillo G, Kopetz ES, Luthra R, Kee BK, Eng C, Morris VK, Karlin-Neumann GA, Meric-Bernstam F, Janku F. Quantity of KRAS mutations in cell-free DNA is associated with survival of patients with advanced cancers. AACR 107th Annual Meeting 76(14 Suppl), 2016. e-Pub 2016.
Johnson A, Khotskaya Y, Brusco L, Zeng J, Holla V, Bailey AM, Litzenburger B, Sanchez N, Shufean MA, Piha-Paul SA, Subbiah V, Hong DS, Naing A, Routbort M, Shaw KR, Mills GB, Mendelsohn J, Meric-Bernstam F. Clinical utilization of precision oncology decision support for genomically-informed cancer therapy. 2016 ASCO Annual Meeting 34(15 Suppl), 2016. e-Pub 2016.
Dembla V, Fu S, Wheler J, Hong DS, Janku F, Zinner R, Piha-Paul SA, Ravi V, Benjamin RS, Patel S, Somaiah N, Herzgog CE, Karp DD, Meric-Bernstam F, Subbiah V. Outcomes of patients with advanced sarcoma enrolled in clinical trials of pazopanib in combination with histone deacetylase, mTOR, Her2, or MEK inhibitors. 2016 ASCO Annual Meeting 34(15 Suppl), 2016. e-Pub 2016.
Piha-Paul SA, Bennouna J, Albright A, Nebozhyn M, McClanahan T, Ayers M, Lunceford JK, Ott PA. T-cell inflamed phenotype gene expression signatures to predict clinical benefit from pembrolizumab across multiple tumor types. 2016 ASCO Annual Meeting 34(15 Suppl), 2016. e-Pub 2016.
Piha-Paul SA, Hierro C, Funk JO, Gourlay S, Smith P, Venetsanakos E, Meric-Bernstam F, Tabernero J. A phase 1, multicenter, dose-escalation study of PRN1371, an irreversible covalent FGFR1-4 kinase inhibitor, in patients with advanced solid tumors, followed by expansion cohorts in patients with FGFR genetic alterations. 2016 ASCO Annual Meeting 34(15 Suppl), 2016. e-Pub 2016.
George G, Iwuanyanwu EC, Yusuf A, Anderson KO, Piha-Paul SA, Naing A, Janku F, Subbiah V, Wang XS, Shi Q, Mendoza TR, Hong DS, Cleeland CS. Symptom clusters in patients with advanced cancer in an early-phase clinical trials clinic. 2016 ASCO Annual Meeting 34(15 Suppl), 2016. e-Pub 2016.
Frenel J-S, Le Tourneau C, O'Neil BH, Ott PA, Piha-Paul SA, Gomez-Roca CA, van Brummelen E, Rugo HS, Thomas S, Saraf S, Chen M, Varga A. Pembrolizumab in patients with advanced cervical squamous cell cancer: Preliminary results from the phase Ib KEYNOTE-028 study. 2016 ASCO Annual Meeting 34(15 Suppl), 2016. e-Pub 2016.
Westin SN, Westin SN, Stashi E, Stashi E, Pal N, Pal N, Urbauer DL, Urbauer DL, Janku F, Janku F, Piha-Paul SA, Piha-Paul SA, Naing A, Naing A, Tsimiberidou AM, Tsimiberidou AM, Fu Hong DS, Fu Hong DS, Subbiah V, Subbiah V. Phase I trial of paclitaxel, bevacizumab, and temsirolimus in advanced solid malignancies. 2016 ASCO Annual Meeting 34(15 Suppl), 2016. e-Pub 2016.
Sen S, Rao A, Janku F, Hong DS, Tsimberdiou AM, Piha-Paul SA, Heymach J, Byers LA, Meric-Bernstam F, Subbiah V. Co-occurring genomic alterations and association with progression free survival in BRAFV600 mutated non-melanoma tumors treated with BRAF inhibitor. 2016 ASCO Annual Meeting 34(15 Suppl), 2016. e-Pub 2016.
Mehnert JM, Varga A, Brose M, Aggarwal RR, Lin C-C, Prawira A, deBraud F, Tamura K, Doi T, Piha-Paul SA, Gilbert J, Saraf S, Thanigaimani P, Cheng JD, Keam B. Pembrolizumab for advanced papillary or follicular thyroid cancer: preliminary results from the phase 1b KEYNOTE-028 study. 2016 ASCO Annual Meeting 34(15 Suppl), 2016. e-Pub 2016.
Cohen RB, Delord J-P, Doi T, Piha-Paul SA, Liu SV, Gilbert J, Algazi AP, Cresta S, Hong R-L, le Tourneau C, Day D, Varga A, Elez E, Wallmark JM, Saraf S, Morosky A, Cheng JD, Keam B. Preliminary results for the advanced salivary gland carcinoma cohort of the phase 1b KEYNOTE-028 study of pembrolizumab. 2016 ASCO Annual Meeting 34(15 Suppl), 2016. e-Pub 2016.
Doi T, Piha-Paul SA, Jalal SI, Mai-Dang H, Saraf S, Koshiji M, Csiki I, Bennouna J. Updated results for the advanced esophageal carcinoma cohort of the phase 1b KEYNOTE-028 study of pembrolizumab. 2016 ASCO Annual Meeting 34(15 Suppl), 2016. e-Pub 2016.
Reilley M, Biley AM, Subbiah V, Janku F, Naing A, Falchook GS, Karp DD, Piha-Paul SA, Tsimberidou AM, Fu S, Zinner R, Lim JA, Bean SA, Bass A, Montez S, Vence LM, Sharma P, Allison JP, Meric-Bernstam F, Hong DS. Phase I clinical trial of combination imatinib and ipilimumab in patients with advanced malignancies. 2016 ASCO Annual Meeting 34(15 Suppl), 2016. e-Pub 2016.
Cascone T, Hess KR, Piha-Paul SA, Hong DS, Subbiah IM, Bhatt T, Fu S, Naing A, Janku F, Karp DD, Meric-Bernstam F, Heymach J, Subbiah V. Safety, toxicity and activity of multi-kinase inhibitor vandetanib in combination with everolimus in advanced solid tumors. 2016 ASCO Annual Meeting 34(15 Suppl), 2016. e-Pub 2016.
Groisberg R, Hong DS, Janku F, Piha-Paul SA, Ravi V, Benjamin RS, Patel S, Somaiah N, Conley AP, Herzog CE, Meric-Bernstam F, Subbiah V. Clinical next-generation sequencing in sarcomas. 2016 ASCO Annual Meeting 34(15 Suppl), 2016. e-Pub 2016.
Moonat HR, Roxas M, Huh WW, Herzog C, Piha-Paul S, Daw NC, Rytting M, Mote E, Ward EN, Amin Y, Meric-Bernstam F, Schwartz CL, Subbiah V. Phase I study of Everolimus (mTOR inhibitor) in combination with Vandetanib (multikinase inhibitor of EGFR,VEGFR,RET) in children, adolescents, and young adults with advanced solid tumors. AACR Annual Meeting 2016 76(5 Suppl), 2016. e-Pub 2016.
Toshihiko D, Piha-Paul SA, Jalal SI, Mai-Dang H, Saraf S, Koshiji M, Csiki I, Bennouna J. Updated results for the advanced esophageal carcinoma cohort of the phase Ib KEYNOTE-028 study of pembrolizumab (MK-3475). ASCO 2016 Gastrointestinal Cancers Symposium 34(suppl 4S), 2016. e-Pub 2016.
Hyman DM, Piha-Paul SA, Rodon J, Saura C, Puzanov I, Shapiro GI, Loi S, Joensuu H, Hanrahan AJ, Modi S, Lalani AS, Xu F, Garza SJ, Cutler RE, Bryce R, Meric-Bernstam F, Baselga J, Solit DB. Neratinib for ERBB2 mutant, HER2 non-amplified, metaststic breast cancer: Preliminary analysis from a multicenter, open-label, multi-histology phase II basket trial. Thirty-Eighth Annual CTRC-AACR San Antonio Breast Cancer Symposium 76(4 Suppl), 2016. e-Pub 2016.
Janku F, Hong DS, Atkins JT, Karp DD, Tsiimberidou AM, Piha-Paul SA, Subbiah V, Naing A, Fu S, Moulder SL, Tripathy D, Meric-Bernstam F, Wheler JJ. Everolimus, Letrozole and Trastuzumab in estrogen receptor and HER2-positive patients with metastatic breast cancer and other solid tumors: Evaluating synergy and overcoming resistance. Thirty-Eighth Annual CTRC-AACR San Antonio Breast Cancer Symposium 76(4 Suppl), 2016. e-Pub 2016.
Rugo HS, Delord JP, IM SA, Ott PA, Piha-Paul SA, Bedard PL, Sachdev J, Le Tourneau C, van Brummelen E, Varga A, Saraf S, Pietrangelo ED, Karantza V, Tan A. Preliminary efficacy and safety of pembrolizumab (MK-3475) in patients with PD-L1 positive, estrogen receptor-positive (ER+)/HER2-negative advanced breast cancer enrolled in KEYNOTE-028. Thirty-Eighth Annual CRTC-AACR San Antonio Breast Cancer Symposium 76(4 Suppl), 2016. e-Pub 2016.
Cascone T, Hess KR, Piha-Paul S, Hong DS, Roxas M, Subbiah IM, Fu S, Naing A, Janku F, Karp D, Sherman SI, Meric-Bernstam F, Heymach JV, Subbiah V. A phase I study of everolimus (mTOR inhibitor) in combination with vandetanib (multikinase inhibitor of VEGFR, EGFR, and RET) in advanced solid tumors including molecularly matched aberrations. AACR-NCI-EORTC International Conference: Molecular Targets and Cancer Therapeutics 14(12 Suppl 2), 2015. e-Pub 2015.
Khawaja MR, Madhusudanannair V, Ng C, Nick A, Janku F, Piha-Paul S, Coleman R, Soliman P, Fu S, Hong D, Karp D, Subbiah V, Tsimberidou A, Meric-Bernstam F, Lu K, Naing A. Phase I dose escalation study of temsirolimus in combination with metformin in patients with advanced cancers. AACR-NCI-EORTC International Conference: Molecular Targets and Cancer Therapeutics 14(12 Suppl 2), 2015. e-Pub 2015.
Subbiah V, Hong DS, Amini B, Piha-Paul S, Fernandez JG, Fu S, Tsimberidou AM, Naing A, Janku F, Karp DD, Overman M, Eng C, Kopetz S, Meric-Bernstam F, Falchook GS. Phase I dose escalation study of the oral multi-kinase VEGF inhibitor regorafenib and the anti-EGFR monoclonal antibody cetuximab in patients with advanced solid tumors including colorectal cancer. AACR-NCI-EORTC International Conference: Molecular Targets and Cancer Therapeutics 14(12 Suppl 2), 2015. e-Pub 2015.
Morris V, Janku F, Huang H, Fu S, Overman M, Piha-Paul Subbiah V, Kee B, Tsimberidou AM, Fogelman D, Shurieqi I, Manuel S, Scamardo A, Lanman R, Sommer N, Hong D, Kopetz S. Circulating cell-free DNA as a marker for response and resistance to BRAF and EGFR inhibition in BRAF-mutated metastatic colorectal cancer. AACR-NCI-EORTC International Conference: Molecular Targets and Cancer Therapeutics 14(12 Suppl 2), 2015. e-Pub 2015.
Piha-Paul SA, Knost JA, Raez KL, Cohn AL, Tawbi HA, Parasuramam S, Kang BP, Matys RM, Slosberg ED. Outcomes and genomic mutational profiling results in patients with cancers of the head and neck treated with dovitinib in the Signature Program. AACR-NCI-EORTC International Conference: Molecular Targets and Cancer Therapeutics 14(12_Suppl_2), 2015. e-Pub 2015.
Piha-Paul SA, Spitz DL, Beck T, Braiteh FS, Buscema J, Frank R, Parasuraman S, Kang BP, Matys RM, Slosbert ED. Outcomes and genomic mutation profiling results in a subset of patients with gynecologic cancers treated with buparlisib in the Signature Program. AACR-NCI-EORTC International Conference: Molecular Targets and Cancer Therapeutics 14(12 Suppl 2), 2015. e-Pub 2015.
Ott PA, Piha-Paul SA, Munster P, Pishvaian MK, Van Brummelen E, Cohen R, Gomez-Roca C, Ejadi S, Stein M, Chan E, Simonelli M, Morosky A, Yuan SS, Koshiji M, Bennoua J. Pembrolizumab (MK-3475) for PD-L1 - positive squamous cell carcinoma (SCC) of the anal canal: preliminary safety and efficacy results from KEYNOTE-028. 40th ESMO European Cancer Congress 2015 51(Suppl 3):S102, 2015. e-Pub 2015.
Kato S, Naing A, Falchook G, Holley VR, Velez-Bravo VM, Patel S, Zinner RG, Piha-Paul SA, Tsimberidou AM, Hong DS, Kurzrock R, Meric-Bernstam F, Janku F. Overcoming BRAF/MEK resistance using vemurafenib with crizotinib or sorafenib in patients with BRAF-mutant advanced cancers: phase I study. AACR Annual Meeting 2015 75(15_Suppl), 2015. e-Pub 2015.
Bendell J, Grant S, Janku F, Infante J, William WN, Bauer TM, Piha-Paul S, Martinez R, Wijayawardana S, Lin J, Golden L, Bence Lin A, Hong DS. Checkpoint kinase (CHK) 1/2 inhibitor LY2606368 in a phase I dose-expansion study in patients with squamous cell carcinoma of the head and neck. AACR Annual Meeting 2015 75(15_Suppl), 2015. e-Pub 2015.
Wheler J, Janku F, Moulder SL, Naing A, Piha-Paul SA, Falchook GS, Zinner R, Tsimberidou AM, Fu S, Hong DS, Atkins JT, Yelensky R, Miller V, Stephens PJ, Valero V, Meric-Bernstam F, Kurzrock R. Anastrozole and everolimus in hormone receptor-positive metastatic breast cancer: activity and associations with molecular alterations in the PI3K/AKT/mTOR pathway. Thirty-Seventh Annual CTRC-AACR San Antonio Breast Cancer Symposium 75(9 Suppl), 2015. e-Pub 2015.
Bendell JC, Eng C, Moore KN, Burris HA, Meric-Bernstam F, Joned SF, Piha-Paul SA, Infante JR, Subbiah V, Bauer TM, Golden L, Lin J, Martinez R, Wijayawardana S, Lin AK, Hong DS. Checkpoint kinase (CHK) 1/2 inhibitor LY2606368 in a phase I, dose-expansion study in patients (pts) with metastatic squamous cell carcinoma (mSCC) of the anus. 2015 ASCO Annual Meeting 33(15 Suppl), 2015. e-Pub 2015.
Hong DS, Morris VK, El Osta BE, Fu S, Overman MJ, Piha-Paul SA, Subbiah V, Kee BK, Tsimberidou MA, Zinner R, Fogelman DR, Bellido J, Shureiqi I, Meric-Bernstam F, Kopetz S. Phase Ib study of vemurafenib in combination with irinotecan and cetuximab in patients with BRAF-mutated metastatic colorectal cancer and advanced cancers. 2015 ASCO Annual Meeting 33(15 Suppl), 2015. e-Pub 2015.
Peguero JA, Knost JA, Bauer TM, Taylor MH, Braiteh FS, Eder JP, Safran H, O'Neil BH, Alva AS, Nadauld L, Joshi P, Miranda F, Sidhu R, Ero J, Slosberg ED, Lebedinsky C, Kang B, Parasuraman S, Piha-Paul S. Successful implementation of a novel trial model: The Signature program. 2015 ASCO Annual Meeting 33(15 Suppl), 2015. e-Pub 2015.
Janku F, Vibat CRT, Falchook GS, Huang HJ, Hong DS, Piha-Paul SA, Subbiah V, Ramzanali NM, Hancock S, Naing A, Karp DD, Nitti G, Cabrilo G, Luthra R, Patel SP, Overman MK, Kopetz S, Erlander MG, Melnikova V, Meric-Bernstam F. Low frequency KRAS G12/13 mutations in urine cell-free (CF) DNA from patients with BRAF V600E-mutant advanced cancers. 2015 ASCO Annual Meeting 33(15 Suppl), 2015. e-Pub 2015.
Kato S, Janku F, Piha-Paul SA, Naing A, Karp DD, Tsimberidou AM, Subbiah V, Zinner R, Hwu W-J, Javle MM, Parkhurst KL, Ramzanali NM, Kurzrock R, Meric-BernstamF, Chae YK, Kim K, Falchook GS. Phase I study of combination vemurafenib, carboplatin, and paclitaxel in patients (pts) with BRAF-mutant advanced cancer. 2015 ASCO Annual Meeting 33(15 Suppl), 2015. e-Pub 2015.
Wheler JJ, Yelensky R, Stephen B, Hong DS, Zinner R Subbiah V, Fu S, Karp DD, Falchook GS, Naing A, Tsimberidou AM, Piha-Paul SA, Janku F, Li Y, Lee JJ, Miller VA, Meric-Bernstam F, Kurzrock R. Prospective study comparing outcomes in patients with advanced malignancies on molecular alteration-matched versus non-matched therapy. 2015 ASCO Annual Meeting 33(15 Suppl), 2015. e-Pub 2015.
Doi T, Piha-Paul SA, Jalal SI, Mai-Dang H, Yuan S, Koshiji M, Csiki I, Bennouna J. Pembrolizumab (MK-3475) for patients (pts) with advanced esophageal carcinoma: Preliminary results from KEYNOTE-028. 2015 ASCO Annual Meeting 33(15 Suppl), 2015. e-Pub 2015.
Kato S, Jardin DLF, Johnson FM, Subbiah V, Piha-Paul SA, Tsimberidou AM, Falchook GS, Karp DD, Wheler JJ, Zinner R, Janku F, Fu S, Dandu L, Browne E, Meric-Bernstam F, Hong DS. Phase I study of combination of crizotinib (C) and dasatinib (D) in patients (pts) with advanced cancer. 2015 ASCO Annual Meeting 33(15 Suppl), 2015. e-Pub 2015.
Rodrigues HV, Lim J, Stephen B, Janku F, Tsimberidou AM, Piha-Paul SA, Fu S, Naing A, Subbiah V, Falchook GS, Kurzrock R, Wheler JJ. Phase I combination of pazopanib and everolimus in PIK3CA mutation positive/PTEN loss patients with advanced solid tumors refractory to standard therapy. 2015 ASCO Annual Meeting 33(15 Suppl), 2015. e-Pub 2015.
Piha-Paul SA, Knost JA, Braiteh FS, Beck JT, Lewis Spitz D, Papish SW, Hellerstedt BA, Nikolinakos P, Taylor MH, Chawla SP, Schwartzberg LS, Smith DA, Szpakowski S, Zhang L, White T, Lebedinsky C. Genomic mutation profiling (GMP) and clinical outcome of patients treated with buparlisib (PI3K inhibitor) in the "Signature" Program. 2015 ASCO Annual Meeting 33(15 Suppl), 2015. e-Pub 2015.
George G, Iwanyansu EC, Anderson KO, Piha-Paul SA, Wheler JJ, Zinner R, Naing A, Tsimberidou AM, Janku F, Subbiah V, Cleeland CS, Mendoza TR, Hong DS. Sleep quality and its association with fatigue, symptom burden, and mood in patients with advanced cancer in a phase 1 clinic. 2015 ASCO Annual Meeting 33(15 Suppl), 2015. e-Pub 2015.
Piha-Paul SA, Goldstein JB, Hess KR, Fu S, Hong DS, Janku F, Karp DD, Naing A, Subbiah V, Tsimberidou AM, Wheler JJ, Zinner R, Mills GB, Meric-Bernstam F. Phase II study of the PARP inhibitor talazoparib (BMN-673) in advanced cancer patients with somatic alterations in BRCA 1/2, mutations/deletions in PTEN or PTEN loss, a homologous recombination defect, mutations/deletions in other BRCA pathway genes and germline mutation S in BRCA1/2 (not breast or ovarian cancer). 2015 ASCO Annual Meeting 33(15 Suppl), 2015. e-Pub 2015.
Falchook GS, Kurzrock R, Amin HM, Fu S, Piha-Paul SA, Janku F, Zheng H, Sarholz B, Johne A, Hong DS. Efficacy, safety, biomarkers, and phase II dose modeling in a phase I trial of the oral selective c-Met inhibitor tepotinib (MSC2156119J). 2015 ASCO Annual Meeting 33(15 Suppl), 2015. e-Pub 2015.
Varga A, Piha-Paul SA, Ott PA, Mehnert JM, Berton-Riguad D, Johnson EA, Cheng JD, Yuan S, Rubin EH, Matei DE. Antitumor activity and safety of pembrolizumab in patients (pts) with PD-L1 positive advanced ovarian cancer: Interim results from a phase Ib study. 2015 ASCO Annual Meeting 33(15 Suppl), 2015. e-Pub 2015.
Park H, Garrido-Laguna I, Naing A, Fu S, Falchook GS, Piha-Paul SA, Wheler JJ, Hong DS, Subbiah V, Tsimberidou AM, Kaseb AO, Oki Y, Zinner R, Patel S, Velez Bravo VM, Fanale MA, Meric-Bernstam F, Kurzrock R, Janku F. Phase I study of the mTOR inhibitor sirolimus and the HDAC inhibitor vorinostat in patients with advanced malignancies. 2015 ASCO Annual Meeting 33(15 Suppl), 2015. e-Pub 2015.
Wagner M, Hess KR, Hong DS, Tang C, Naing A, Fu S, Janku F, Piha-Paul SA, Zinner R, Wheler JJ, Tsimberidou AM, Patek S, Somaiah N, Ravi V, Benjamin RS, Meric-Bernstam F, Subbiah V. Validation of the Royal Marsden Hospital (RMH) prognostic score in 100 patients with advanced sarcoma enrolled in early phase clinical trials at a major cancer center. 2015 ASCO Annual Meeting 33(15 Suppl), 2015. e-Pub 2015.
Janku F, Janku F, Huang HJ, Huang HJ, Claes B, Claes B, Falchook GS, Falchook GS, Fu S, Fu S, Tsimberidou AM, Tsimberidou AM, Hong DS, Hong DS, Naing A, Naing A, Wheler JJ, Wheler JJ, Piha-Paul SA, Piha-Paul SA, Karp DD, Karp DD, Subbiah V, Subbiah V, Zinner RG, Zinner RG, Ramzanali N, Ramzanali N, Luthra R, Luthra R, Patel SP, Patel SP, Kopetz ES, Kopetz ES, Sablon E, Sablon E, Maertens G, Maertens G, Kurzrock R, Kurzrock R, Meric-Bernstam F, Meric-Bernstam F. Rapid, automated BRAF mutation testing of cell-free DNA from plasma of patients with advanced cancers using the novel Idylla platform. AACR Annual Meeting 2015 75(15 Suppl), 2015. e-Pub 2015.
Huang HJ, Shelton DN, Fu S, Piha-Paul SA, Tsimberidou AM, Zinner RG, Wheler JJ, Naing A, Hong DS, Falchook GS, Kopetz S, Luthra R, Kee BK, Karlin-Neumann GA, Meric-Bernstam F, Janku F. Multiplex KRAS G12/G13 mutation testing of 16ng of unamplified cell-free DNA from plasma of patients with advanced cancers using Droplet Digital PCR. AACR Annual Meeting 2015 75(15 Suppl), 2015. e-Pub 2015.
Piha-Paul S, Knost J, Nikolinakos P, Schwartzberg L, Yardley D, Solsberg E, Kang B, White T, Lebedinsky C. Colorectal cancer (CRC) cohort analysis of patients treated with buparlisib in a distinctive tissue-agnostic trial model for molecularly preselected tumors. 2015 Gastrointestinal Cancers Symposium 33(3 Suppl), 2015. e-Pub 2015.
Goldstein JB, Tang C, Hong DS, Subbiah V, Janku F, Hess KR, Fu S, Karp DD, Naing A, Tsimberidou AM, Wheler JJ, Zinner R, Javle MM, Varadhachary V, Wolff RA, Fogelman DR, Meric-Bernstam F, Piha-Paul SA. Evolution of phase 1 trials for patients with advanced pancreatic cancer: An update of the experience from MD Anderson Cancer Center. 2015 Gastrointestinal Cancers Symposium 33(3 Suppl), 2015. e-Pub 2015.
Giles F, Piha-Paul SA, Spira AI, Braiteh F, Peguero JA, Spitz DL, Knost JA, Schwartzberg L, Stein S, Salvado AJ, Lebedinsky C, Kang B, Slosberg E. The signature program, a distinctive tissue agnostic trial model for molecularly pre-selected hematological and solid tumor patients. 56th ASH Annual Meeting 124(21):4818, 2014. e-Pub 2014.
Janku F, Huang HJ, Claes B, Falchook GS, Naing A, Piha-Paul S, Tsimberidou AM, Zinner RG, Karp DD, Fu S, Subbiah V, Hong DS, Wheler JJ, Luthra RG, Patel SP, Kopetz ES, Sablon E, Maertens G, Kurzrock R, Meric-Bernstam F. BRAF mutation testing in cell-free DNA from plasma of patients with advanced cancers using a novel, rapid, automated molecular diagnostics prototype platform (Idylia™). 26th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics 50(Suppl 6):56-57, 2014. e-Pub 2014.
Meric-Bernstam F, Brusco L, Kopetz S, Davies M, Routbort MJ, Piha-Paul SA, Alvarez R, Khose S, DeGroot J, Ravi V, Janku F, Hong D, Li Y, Luthra R, Patel KP, Broaddus R, Shaw K, Mendelsohn J, Mills GB. Feasibility of large-scale genomic testing to facilitate enrollment on genomically-matched clinical trials. 26th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics, 50(Suppl 6):3, 2014. e-Pub 2014.
Liu X, Hou M, Wheler J, Naing A, Hong D, Tsimberidou AM, Piha-Paul SA, Zinner R, Falchook G, Janku F, Ramondetta L, Schmeler K, Lu K, Kurzrock R, Fu S. Differential effect of PIK3CA mutations and PTEN loss in patients with advanced endometrial cancers on matched therapy. AACR Annual Meeting 2014 74(19 Suppl), 2014. e-Pub 2014.
Huang HJ, Claes B, Falchook GS, Holley VR, Naing A, Piha-Paul SA, Tsimberidou AM, Zinner RG, Karp DD, FU S, Subbiah V, Hong DS, Wheler JJ, Stepanek VM, Cabrilo G, Luthra R, Bedikian AY, Kee BK, Eng C, Overman MJ, Kim KB, Ivens T, Sablon E, Maertens G, Kurzrock R, Meric-Bernstam F, Janku F. BRAF mutation testing in cell-free DNA from plasma of patients with advanced cancers using a novel, rapid, automated molecular diagnostics prototype platform (Idylia™). AACR Annual Meeting 2014 74(19 suppl), 2014. e-Pub 2014.
Janku F, Falchook GS, Piha-Paul SA, Naing A, Holley VR, Hong DS, Subbiah V, Karp DD, Zinner RG, Fu S, Wheler JJ, Meric-Bernstam F, Stepanek VM, Luthra R, Leppin l, Hassaine L, Kosco K, Erlander MG. Digital droplet PCR detection and monitoring of BRAF mutations in cell-free urinary DNA of patients with metastatic cancers or Erdheim-Chester disease. AACR Annual Meeting 2014 74(19 suppl), 2014. e-Pub 2014.
Hong DS, Kim Y, Younes A, Nemunaitis J, Fowler N, Hsu J, Zhou T, Fayad L, Zhang N, Piha-Paul S, Woessner R, Nadella MVP, Lawson D, Reimer C, Jo M, Schmidt J, Xiao X, Greenlee S, Hung G, Yamashita M, Blakey DC, Monia BP, Macleod AR, Kurzrock R. Preclinical pharmacology and clinical efficacy of AZD9150 (ISIS-STAT3Rx), a potent next-generation antisense oligonucleotide inhibitor of STAT3. AACR Annual Meeting 2014 74(19 Suppl), 2014. e-Pub 2014.
Tsimberidou AM, Culotta K, Wistuba I, Fu S, Naing A, Falchook GS, Piha-Paul S, Zinner RG, Siddik ZH, He G, Said R, Hess K, Stewart D, Kurzrock R, Issa J-P. Phase I study of 5-azacytidine and oxaliplatin in patients with advanced cancers relapsed or refractory to platinum compounds. AACR Annual Meeting 2014 74(19 Suppl), 2014. e-Pub 2014.
Falchook GS, Hong DS, Amin HM, Fu S, Piha-Paul SA, Janku F, Granada JG, Zheng H, Klevesath MB, Kohler K, Bladt F, Johne A, Kurzrock R. MSC2156119J (EMD 1214063), an oral selective c-Met inhibitor, in patients with advanced solid tumors: results of the first-in-human phase I trial. AACR Annual Meeting 2014 74(19 Suppl), 2014. e-Pub 2014.
Falchook GS, Hong DS, Amin HM, Fu S, Piha-Paul SA, Janku F, Zheng H, Bladt F, Johne A, Kurzrock R. First-in-human phase I trial assessing the highly selective c-Met inhibitor MSC2156119J (EMD 1214063) in patients with advanced solid tumors. ESMO Congress 2014 25(Suppl_4), 2014. e-Pub 2014.
Livingston JA, Livingston JA, KR Hess, KR Hess, Fernandez JG, Fernandez JG, Naing A, Naing A, Hong DS, Hong DS, Patel S, Patel S, Anderson PM, Anderson PM, Benjamin RS, Benjamin RS, Ludwig JA, Ludwig JA, Herzog CE, Herzog CE, Fu S, Fu S, Wheler JJ, Wheler JJ, Falchook GS, Falchook GS, Tsimberidou AM, Tsimberidou AM, Piha-Paul SA, Piha-Paul SA, Janku F, Janku F, Rohren E, Rohren E, Meric-Bernstam F, Meric-Bernstam F, Kurzrock R, Kurzrock R, Subbiah V, Subbiah V. Eliciting early-response signals from first-in-human clinical trials and validation of prognostic scores in aggressive biology bone cancers: The MD Anderson experience. ASCO Annual Meeting I 32(15), 2014. e-Pub 2014.
Livingston JA, Hess K, Fernandez JG, Naing A, Hong D, Patel S, Anderson P, Benjamin R, Ludwig J, Herzog C, Fu S, Wheler J, Falchook G, Tsimberidou AM, Piha-Paul S, Janku F, Rohren E, Meric-Bernstam F, Kurzrock R, Subbiah V. Eliciting early response signals from first in human clinical trials and validation of prognostic scores in aggressive biology bone cancers: the MD Anderson experience. ASCO Annual Meeting 2014 32(15 suppl), 2014. e-Pub 2014.
Wheler J, Janku F, Atkins JT, Moulder SL, Zinner R, Lee J, Falchook GS, Tsimberidou AM, Piha-Paul S, Karp DD, Naing A, Fu S, Hong DS, Subbiah V, Stephens PJ, Yelensky R, Miller VA, Valero V, Kurzrock R, Meric-Bernstam F. PI3K/AKT/mTOR genomic alterations in 94 patients with metastatic breast cancer in the phase I clinic at MD Anderson: prevalence and association with response. ASCO Annual Meeting 2014 32(15 suppl), 2014. e-Pub 2014.
Fu S, Fu S, Nguyen E, Nguyen E, Janku F, Janku F, Subbiah V, Subbiah V, Patel S, Patel S, Naing A, Naing A, Falchook G, Falchook G, Zinner R, Zinner R, Tsimberidou A, Tsimberidou A, Hong DS, Hong DS, Piha-Paul S, Piha-Paul S, Wheler J, Wheler J, Shi N, Shi N, Bomalaski J, Bomalaski J, Hwu P, Hwu P, Meric-Bernstam F, Meric-Bernstam F. Targeting argininosuccinate synthetse-deficient advanced solid tumors in a phase I trial of ADI-PEG20 plus cisplatin. ASCO 2014 Annual Meeting 32(15 suppl), 2014. e-Pub 2014.
Bupathi M, Falchook G, Hong D, Subbiah I, Piha-Paul S, Karp D, Saigal B, Zinner R, Wheler J, Tsimberidou A, Fu S, Sherman S, Meric-Bernstam F, Subbiah V. A phase I trial of vandetanib (multikinase inhibitor of EGFR, VEGFR and RET) in combination with everolimus (mTOR inhibitor) in patients with advanced malignancies. 2014 ASCO Annual Meeting 32(15 suppl), 2014. e-Pub 2014.
Hou M-M, Bellido J, Naing A, Falchook G, Hess K, Zinner R, Janku F, Wheler J, Subbiah V, Hong DS, Piha-Paul S, Tsimberidou A, Karp D, Kurzrock R, Meric-Bernstam F, Fu S. A phase I trial of pazopanib and vorinostat: The role of TP53 mutations. 2014 ASCO Annual Meeting 32(15 suppl), 2014. e-Pub 2014.
Gupta S, Munster PN, Hollebecque A, Argiles G, Dajani O, Chen JD, Swift AM, Tolosini A, Piha-Paul SA. Safety/efficacy of MK-8669 (ridaforolimus) plus MD-2206 (AKT inhibitor) in patients with advanced breast cancer with low RAS signature and PTEN deficient prostate cancer. 2014 ASCO Annual Meeting 32(15 suppl), 2014. e-Pub 2014.
Naing A, Naing A, Habra MA, Habra MA, Fu S, Fu S, Piha-Paul SA, Piha-Paul SA, Lizeman M, Lizeman M, Hein JP, Hein JP, Phillips M, Phillips M, Smith DC, Smith DC. Phase 1 study of ATR-101 in adrenocortical carcinoma (ACC): ATR-101-001. 2014 ASCO Annual Meeting 32(15 suppl), 2014. e-Pub 2014.
Slosberg ED, Kang B, Beck JT, Piha-Paul SA, Green RJ, Richards DA, Corless CL, Berry DA, Stein SH, Salvado AJ. The signature program, a series of tissue-agnostic, mutation-specific signal finding trials. 2014 ASCO Annual Meeting 32(15 suppl), 2014. e-Pub 2014.
Hong DS, Hong DS, Hong DS, Hong DS, Morris V, Morris V, Morris V, Morris V, Fu S, Fu S, Fu S, Fu S, Overman M, Overman M, Overman M, Overman M, Piha-Paul S, Piha-Paul S, Piha-Paul S, Piha-Paul S, Kee B, Kee B, Kee B, Kee B, Zinner R, Zinner R, Zinner R, Zinner R, Fogelman D, Fogelman D, Fogelman D, Fogelman D, Shurequi I, Shurequi I, Shurequi I, Shurequi I, Meric-Bernstam F, Meric-Bernstam F, Meric-Bernstam F, Meric-Bernstam F, Kopetz S, Kopetz S, Kopetz S, Kopetz S. Phase 1B study of Vemurafenib in combination with irinotecan and cetuximab in patients with BRAF-mutated advanced cancers and metastatic colorectal cancer. ASCO Annual Meeting 2014 32(15 suppl), 2014. e-Pub 2014.
Boland MG, Piha-Paul S, Subbiah V, Brusco L, Herbrich SM, Baggerly KA, Routbort M, Patel K, Luthra R, Naing A, Fu S, Falchook GS, Hong DS, Wheler JJ, Janku F, Shaw K, Aldape KD, Mendelsohn J, Mills GB, Meric-Bernstam F. Clinical next-generation sequencing to identify actionable alterations in a phase I program. 2014 ASCO Annual Meeting 32(15 suppl), 2014. e-Pub 2014.
Liu X, George GC, Tsimberidou A, Naing A, Wheler J, Kopetz S, Fu S, Piha-Paul S, Eng C, Falchook G, Janku F, Garrett C, Karp D, Kurzrock R, Zinner R, Raghav K, Subbiah V, Meric-Bernstam F, Hong DS, Overman M. Rechallenge with anti-EGFR therapy in metastatic colorectal cancer: impact of intervening time interval and prior anti-EGFR response. ASCO Annual Meeting 2014 32(15 suppl), 2014. e-Pub 2014.
Falchook GS, Falchook GS, Hong DS, Hong DS, Amin HM, Amin HM, Fu S, Fu S, Piha-Paul SA, Piha-Paul SA, Janku F, Janku F, Granda JG, Granda JG, Zheng H, Zheng H, Klevesath MB, Klevesath MB, Köhler K, Köhler K, Bladt F, Bladt F, Johne A, Johne A, Kurzrock R, Kurzrock R. Results of the first-in-human phase I trial assessing MSC2156119J (EMD 1214063), an oral selective c-Met inhibitor, in patients (pts) with advanced solid tumors. ASCO 2014 Annual Meeting 32(15 suppl), 2014. e-Pub 2014.
Huang HJ, Claes B, Falchook GS, Holley VR, Naing A, Piha-Paul SA, Tsimberidou AM, Zinner RG, Karp DD, FU S, Subbiah V, Hong DS, Wheler JJ, Stepanek VM, Cabrilo G, Luthra R, Bedikian AY, Kee BK, Eng C, Overman MJ, Kim KB, Ivens T, Sablon E, Maertens G, Kurzrock R, Meric-Bernstam F, Janku F. BRAF mutation testing in cell-free DNA from plasma of patients with advanced cancers using a novel, rapid, automated molecular diagnostics prototype platform (Idylia™). 2014 ASCO Annual Meeting 32(15 suppl), 2014. e-Pub 2014.
Tsimberidou AM, Ye Y, Wheler JJ, Falchook GS, Hong DS, Naing A, Fu S, Kurzrock R, Piha-Paul S, Janku F, Zinner R, Moulder S, Subbiah V, Karp D, Meric-Bernstam F, Hwu P, Kies MS, Sherman SI, Wolff RA, Coleman R, Miller V, Aldape K, Broaddus R, Berry D, Hess K. Genomic profiling and precision medicine in 3,745 patients with advanced cancer. 2014 ASCO Annual Meeting 32(15 suppl), 2014. e-Pub 2014.
Janku F, Vibat CF, Falchook GS, Piha-Paul S, Naing A, Holley VR, Subbiah V, Wheler JJ, Meric-Bernstam F, Cabrilo G, Luthra R, Leppin L Hassaine L, Kosco K, Erlander MG. Longitudinal monitoring of BRAf V600E mutation in urinary cell-free DNA of patients with metastatic cancers using droplet digital PCR. 2014 ASCO Annual Meeting 32(15 suppl), 2014. e-Pub 2014.
Subbiah V, Corrales-Medina FF, Herzog CE, Hess KR, Egas Bejar DE, Hong DS, Falchook GS, Meade Anderson P, Nunez C, Huh WW, Naing A, Tsimberidou AM, Wheler JJ, Piha-Paul SA, Janku F, Kleinerman E, Kurzrock R. Outcomes of pediatric cancer patients enrolled in phase 1 clinical trials designed for adults: Experience from a major cancer center. 2014 ASCO Annual Meeting 32(15 suppl), 2014. e-Pub 2014.
Legendre B, Richardson K, Falchook GS, Naing A, Holley VR, Fu S, Hong DS, Piha-Paul S, Wheler JJ, Zinner RG, Subbiah V, Tsimberidou AM, Karp DD, Stepanek VM, Cabrilo G, Luthra R, Meric-Bernstam F, Bedikian AY, Kee BK, Eng C, Overman MJ, Kim KM, Kruempel A, Pope J, Cubrich C, Wu G, Lewis M, Kurzrock R, Janku F. BRAF and KRAS mutation testing in plasma cell-free DNA with ICE-COLD PCR patients with advanced cancers. 2014 ASCO Annual Meeting 32(15 suppl), 2014. e-Pub 2014.
Gupta S, Munster P, Hollebecque A, Argiles G, Guren T, Cheng J, Wang R, Swift A, Tosolini A, Piha-Paul S. Safety and efficacy of MK-8669 (Ridaforolimus) + MKI-2206 (AKT inhibitor) in patients with advanced breast cancer with PI3K pathway dependence. IMPAKT Breast Cancer Conference 25(Suppl 1):i25, 2014. e-Pub 2014.
Huang M, Parkhurst KL, Jiang JF, Moulder SL, Naing A, Wheler JJ, Hong DS, Piha-Paul S, Fu S, Tsimberidou A, Zinner R, Janku F, Kurzrock R, Falchook GS. HER2 extracellular domain (ECD) and HER 2 single nucleotide polymorphisms (SMPs) in patients treated with combination trastuzumab, lapatinib, and bevacizumab. 2014 ASCO Annual Meeting 32(15 suppl), 2014. e-Pub 2014.
Piha-Paul SA, Munster PN, Hollebecque A, Argiles G, Dajani O, Cheng JD, Wang R, Swift AM, Tololini A, Gupta S. Results of a phase I trial combining ridaforolimus (mTOR inhibitor) and MK-0752 (Notch inhibitor) in patients with advanced solid tumors. 2014 ASCO Annual Meeting 32(15 suppl), 2014. e-Pub 2014.
Janku F, Legendre B, Richardson K, Falchook GS, Naing A, Holley VR, Fu S, Hong DS, Piha-Paul SA, Wheler JJ, Zinner RG, Subbiah V, Tsimberidou AM, Karp DD, Stepanek VM, Cabrilo G, Luthra R, Meric-Bernstam F, Bedikian AY, Kee BK, Eng C, Overman MJ, Kim KB, Kruempel A, Pope J, Cubrich C, Wu G, Shi Y, Lewis M, Kurzrock R. BRAF and KRAS mutation testing in plasma cell-free DNA with ICE-COLD PCR in patients with advanced cancers. AACR Annual Meeting 2014 74(19 suppl), 2014. e-Pub 2014.
Fontes Jardim DL, De Melo Gagliato D, Falchook GS, Wheler JJ, Zinner R, Janku F, Subbiah V, Piha-Paul SA, Fu S, Tannir NM, Corn PG, Tang C, Hess KR, Roy-Chowdhuri S, Kurzrock R, Meric-Bernstam F, Hong DS. c-MET abnormalities in patients with genitourinary (GU) malignancies and outcomes with c-MET inhibitors. 2014 Genitourinary Cancers Symposium 32(4 suppl), 2014. e-Pub 2014.
Hou M-M, Liu X, Piha-Paul SA, Janku F, Wheler JJ, Naing A, Bodurka D, Schmeler K, Lu K, Zinner R, Hong D, Meric-Bernstam F, Kurzrock R, Fu S. Target-matched therapies in patients with advanced cervical cancers harboring PIK3CA mutations and/or PTEN loss. AACR-NCI-EORTC International Conference: Molecular Targets and Cancer Therapeutics 12(11 Suppl), 2013. e-Pub 2013.
Janku F, Angenendt P, Naing A, Falchook GS, Tsimberidou AM, Holley VR, Fu S, Hong DS, Wheler JJ, Piha-Paul SA, Zinner RG, Karp DD, Subbiah V, Kim KB, Meric-Bernstam F, Diehl F, Kurzrock R. Actionable mutations in cell-free DNA in plasma of patients with advanced cancers referred for experimental targeted therapies. AACR-NCI-EORTC International Conference: Molecular Targets and Cancer Therapeutics 12(11_Suppl), 2013. e-Pub 2013.
Huang HJ, Falchook GS, Tsimberidou AM, Holley VR, Subbiah V, Zinner RG, Naing A, Karp DD, Piha-Paul SA, Wheler JJ, Fu S, Hong DS, Stepanek VM, Luthra R, Meric-Bernstam F, Ivens T, Sablon E, Maertens G, Kee BK, Kurzrock R, Scherer S, Janku F. BRAF mutation testing in cell-free DNA from plasma of patients with advanced cancers using a novel, rapid, automated molecular diagnostics prototype platform. AACR-NCI-EORTC International Conference: Molecular Targets and Cancer Therapeutics 12(11 Suppl), 2013. e-Pub 2013.
Janku F, Janku F, Falchook GS, Falchook GS, Piha-Paul SA, Piha-Paul SA, Naing A, Naing A, Tsimberidou AM, Tsimberidou AM, Holley VR, Holley VR, Karp DD, Karp DD, Zinner RG, Zinner RG, Fu S, Fu S, Wheler JJ, Wheler JJ, Hong DS, Hong DS, Meric-Bernstam F, Meric-Bernstam F, Stepanek VM, Stepanek VM, Luthra R, Luthra R, Leppin L, Leppin L, Hassaine L, Hassaine L, Kosco K, Kosco K, Pooke JC, Pooke JC, Erlander MG, Erlander MG. Detection and monitoring of BRAF and KRAS mutations in cell-free urinary DNA of metastatic cancer patients by droplet digital PCR. AACR-NCI-EORTC International Conference: Molecular Targets and Cancer Therapeutics 12(11 Suppl), 2013. e-Pub 2013.
Huang HJ, Huang HJ, Claes B, Claes B, Falchook GS, Falchook GS, Devogelaere B, Devogelaere B, Naing A, Naing A, Fu S, Fu S, Piha-Paul SA, Piha-Paul SA, Hong DS, Hong DS. BRAF mutation testing of archival tumor samples with a novel, rapid, fully-automated molecular diagnostics prototype platform. AACR-NCI-EORTC International Conference: Molecular Targets and Cancer Therapeutics 12(11 Suppl), 2013. e-Pub 2013.
Bilen MA, Fu S, Hong DS, Wheler JJ, Abdelrahim M, Falchook GS, Tsimberidou AM, Janku F, Piha-Paul SA, Zinner R, Kurzrock R, Naing A. Phase I trial of lenalidomide and valproic acid in patients with advanced cancer. AACR-NCI-EORTC International Conference: Molecular Targets and Cancer Therapeutics 12(11 Suppl), 2013. e-Pub 2013.
Janku F, Legendre B, Richardson K, Falchook GS, Naing A, Holley VR, Hong DS, Zinner RG, Fu S, Tsimberidou AM, Subbiah V, Karp DD, Piha-Paul SA, Wheler JJ, Stepanek VM, Cabrilo G, Luthra R, Meric-Bernstam F, Kruempel A, Pope J, Cubrich C, Wu G, Shi Y, Lewis M, Kurzrock R. BRAF and KRAS mutation testing in cell-free DNA and circulating tumor cells from blood of patients with metastatic cancers. AACR-NCI-EORTC International Conference: Molecular Targets and Cancer Therapeutics 12(11 Suppl), 2013. e-Pub 2013.
Ganeshan P, Piha-Paul SA, Naing A, Falchook GS, Wheler JJ, Janku F, Zinner R, Laday S, Kies MS, Tsimberidou AM. Phase I clinical trial of lenalidomide with temsirolimus in patients with advanced cancer. 2013 ASCO Annual Meeting 31(15S), 2013. e-Pub 2013.
Falchook GS, Hong DS, Amin HM, Fu S, Piha-Paul SA, Janku F, Subbiah V, Naing A, Wheler JJ, Klevesath MB, Köhler K, Johne A, Bladt F, Kurzrock R. Phase I study of oral selective c-Met inhibitor EMD 1214063 in pts with advanced solid tumors. 2013 ASCO Annual Meeting 31(15_suppl), 2013. e-Pub 2013.
M-M H, Liu X, Wheler JJ, Naing A, Hong DS, Bodurka DC, Schmeler KM, Tsimberidou AM, Janku F, Zinner R, Piha-Paul S, Lu KH, Wolff RA, Kurzrock R, Fu S. Outcome analyses of patients with metastatic cervical cancers in a phase I clinic. 2013 ASCO Annual Meeting 31(15S), 2013. e-Pub 2013.
Westin SN, Smart ML, Pal N, Urbauer DL, Janku F, Wheler JJ, Piha-Paul, Naing A, Tsimberidou AM, Fu S, Falchook GS, Hong DS, Zinner R, Subbiah V, Culotta KS, Lu KH, Coleman RL, Kurzrock R. Phase I trial of sorafenib, bevacizumab, and temsirolimus in advanced solid tumors. 2013 ASCO Annual Meeting 31(15S), 2013. e-Pub 2013.
Huang HJ, Devogelaere B, Falchook GS, Fu S, Angelo LS, Hong DS, Piha-Paul SA, Naing A, Holley VR, Tsimberidou AM, Stepanek VMT, Kim K, Subbiah V, Wheler JJ, Zinner R, Wolff RA, Sablon E, Maertens G, Kurzrock R, Janku F. BRAF mutation testing with a novel, rapid, fully automated molecular diagnostics prototype platform. 2013 ASCO Annual Meeting 31(15S), 2013. e-Pub 2013.
Tsimberidou AM, Said R, Falchook GS, Janku F, Naing A, Zinner R, Blumenschein G, Fu S, Hong D, Piha-Paul S, Wheler J, Ye Y, Hess K, Palmer G, Wolff RA, Kurzrock R. Outcomes of patients with advanced cancer and KRAS mutation in phase I clinical trials. 2013 ASCO Annual Meeting 31(15S), 2013. e-Pub 2013.
Liu X, Liu X, Liu X, Hong DS, Hong DS, Hong DS, Fu S, Fu S, Fu S, Piha-Paul SA, Piha-Paul SA, Piha-Paul SA, McQuinn L, McQuinn L, McQuinn L, Falchook GS, Falchook GS, Falchook GS, Williams J, Williams J, Williams J, Karp DD, Karp DD, Karp DD, Subbiah V, Subbiah V, Subbiah V, Tsimberidou AM, Tsimberidou AM, Tsimberidou AM, Janku F, Janku F, Janku F, Zinner R, Zinner R, Zinner R, Wheler JJ, Wheler JJ, Wheler JJ, Wolff, Wolff RA, Wolff RA, Kurzrock R, RA, Kurzrock R, Naing A, Naing A, Kurzrock R, Naing A. Incidence of mucositis in patients treated with mTOR inhibitor-based regimens and correlation to treatment response. 2013 ASCO Annual Meeting 31(15S), 2013. e-Pub 2013.
Wheler JJ, Moulder SL, Naing A, Janku F, Piha-Paul SA, Falchook GS, Zinner R, Tsimberidou AM, Fu S, Hong DS, Atkins JT, Cronin M, Yelensky R, Stephens P. A dose-escalation study of anastrozole and everolimus in patients with advanced gynecologic and breast malignancies: tolerance, biological activity, and molecular alterations in the PI3K/AKT/mTOR pathway. 104th AACR Annual Meeting 73(8 Suppl), 2013. e-Pub 2013.
Ganesan P, Piha-Paul SA, Naing A, Falchook GS, Wheler JJ, Fu S, Hong DS, Kurzrock R, Janku F, Laday S, Bedikian AY, Kies M, Wolff R, Tsimberidou AM. Phase I clinical trial of Lenalidomide in combination with Sorafenib in patients with advanced cancer. 104th AACR Annual Meeting 73(8 Suppl), 2013. e-Pub 2013.
Chae YK, Kim K, Hong DS, Falchook GS, Piha-Paul S, Wheler JJ, Naing A, Fu S, Tsimberidou AM, Zinner RG, Subbiah V, Stepanek VM, Wolff RA, Kurzrock R, Janku F. PIK3CA mutation, aspirin use and mortality in patients with metastatic colorectal cancer participating in early-phase clinical trials. 104th AACR Annual Meeting 73(8 Suppl), 2013. e-Pub 2013.
Janku F, Hong DS, Piha-Paul SA, Naing A, Falchook GS, Tsimberidou AM, Stepanek VM, Wheler JJ, Kurzrock R. Aberrations in PIK3CA, PTEN, and MAPK (KRAS, NRAS, BRAF) in 1,656 patients and experience with early-phase protocols with PI3K/AKT/mTOR inhibitors. EORTC-NCI-AACR Symposium on Molecular Targets and cancer Therapeutics 48(Suppl 6):76, 2012. e-Pub 2012.
Naing A, Mita M, Komarnitsky P, Milner A, von Richter O, Ogden J, Piha-Paul S, Fu S, Kurzrock R. Phase I dose-escalation trial of a selective oral MEK1/2 inhibitor, pimasertib (MSC1936369B), combined with an mTOR inhibitor, temsirolimus, in patients with advanced solid tumors. EORTC–NCI–AACR Symposium on Molecular Targets and Cancer Therapeutics 48(Suppl 6):187, 2012. e-Pub 2012.
Naing A, Falchook GS, Amin HM, Piha-Paul SA, Hong DS, Tsimberidou AM, Wheler JJ, Janku F, Klevesath MB, Jego V, Johne A, Kurzrock R. A phase I dose-escalation study of EMD 1214063, an oral selective cMet inhibitor, in patients with advanced solid tumors. 10th Annual Meeting of the Japanese Society of Medical Oncology (JSMO) 23(Suppl 11), 2012. e-Pub 2012.
Falchook GS, Hong DS, Amin HM, Fu S, Piha-Paul, Klevesath MB, Jego V, Johne A, Stinchi S, Kurzrock R. Phase I dose-escalation study of oral selective c-Met inhibitor EMD 1214063 in patients with advanced solid tumors. 37th ESMO Congress 23(Suppl 9):iv149-iv150, 2012. e-Pub 2012.
Subbiah IM, Tsimberidou AM, Naing A, Subbiah V, Kaseb AO, Fu S, Hong DS, Piha-Paul SA, Wheler JJ, Janku F, Hess KR, Falchook GS, Kurzrock R. Early-phase trials compared to first-and second-line FDA-approved treatments in patients with advanced gallbladder cancer and cholangiocarcinoma. 2012 ASCO Annual Meeting 30(15S), 2012. e-Pub 2012.
Said R, Hong DS, Wheler JJ, Naing A, Falchook GS, Fu S, Janku F, Zinner R, Piha-Paul SA, Warneke CL, Tsimberidou AM, Kurzrock R. p53 mutations in advanced cancers: Clinical characteristics and outcomes in a phase I setting. 2012 ASCO Annual Meeting 30(15S), 2012. e-Pub 2012.
Amin HM, Falchook GS, Fu S, Hong DS, Tsimberidou AM, Naing A, Wheler JJ, Piha-Paul SA, Janku F, Klevesath MB, Jego V, Johne A, Kurzrock R. First-in-human phase I dose-escalation study of the oral selective C-met inhibitor EMD 1204831 in patients with advanced solid tumors. 2012 ASCO Annual Meeting 30(15S), 2012. e-Pub 2012.
Janku F, Broaddus R, Bakkar R, Hong DS, Stepanek VM, Naing A, Falchook GS, Fu S, Wheler JJ, Piha-Paul SA, Moulder SL, Luthra R, Tsimberidou AM, Kurzrock R. PTEN assessment and PI3K/mTOR inhibitors: Importance of simultaneous assessment of MAPK pathway aberrations. 2012 ASCO Annual Meeting 30(15S), 2012. e-Pub 2012.
Madhusudanannair V, Janku F, Falchook GS, Hong DS, Wheler JJ, Naing A, Fu S, Piha-Paul SA, El-Osta HE, Luthra R Tsimberidou AM, Kurzrock R. NRAS mutations in patients with advanced cancers treated with target-based therapies in early-phase clinical trials. 2012 ASCO Annual Meeting 30(15S), 2012. e-Pub 2012.
Henary HA, Hong DS, Falchook GS, Tsimberidou AM, George G, Wheler JJ, Fu S, Naing A, Piha-Paul SA, Janku F, Kim KB, Hwu P, Kurzrock R. Targeted agents matched with tumor molecular aberrations: Review of 160 patients with advanced melanoma treated in a phase I clinic. 2012 ASCO Annual Meeting 30(15S), 2012. e-Pub 2012.
Subbiah IM, Tsimberidou AM, Naing A, Subbiah V, Kaseb AO, Fu S, Hong DS, Piha-Paul SA, Wheler JJ, Janku F, Hess KR, Falchook GS, Kurzrock R. Early-phase trials compared to first- and second-line FDA-approved treatments in patients with advanced gallbladder cancer and cholangiocarcinoma. 2012 ASCO Annual Meeting 30(15S), 2012. e-Pub 2012.
Subbiah IM, KurzrockR, Naing A, Piha-Paul S, Falchook GS, Hong DS, Wheler JJ, Fu S, Laday S, Tsimberidou AM. A phase I study of lenalidomide in combination with bevacizumab, sorafenib, temsirolimus, or 5-fluorouracil, leucovorin, oxaliplatin (FOLFOX) in patients with advanced cancers. AACR 103rd Annual Meeting 72(8_Suppl), 2012. e-Pub 2012.
Subbiah IM, Subbiah V, Kaseb AO, Janku F, Wheler JJ, Naing A, Piha-Paul SA, Hong DS, Falchook GS, Tsimberidou AM, Kurzrock R. Characteristics and outcomes of patients with gallbladder cancer and cholangiocarcinoma referred to a phase I clinic. J Clin Oncol, 2012 Gastrointestinal Cancers Symposium 40(4), 2012. e-Pub 2012.
Janku F, Naing A, Falchook GS, Tsiimberidou AM, Stepanek VM, Piha-Paul SA, Luthra R, Hong DS, Kurzrock R. Target-based therapeutic matching in early-phase clinical trials in patients with advanced colorectal cancer and PIK3CA mutations. J Clin Oncol, 2012 Gastrointestinal Cancers Symposium 30(4S), 2012. e-Pub 2012.
LoRusso PM, Piha-Paul SA, Colevas AD, Malhi V, Colburn D, Yin M, Low JA, Graham RA. Pharmacokinetic assessment of drug-drug interaction potential when rosiglitazone or combined oral contraceptive is coadministered with vismodegib in patients with locally advanced or metastatic solid tumors. AACR-NCI-EORTC International Conference: Molecular Targets and Cancer Therapeutics 10(11), 2011. e-Pub 2011.
Falchook GS, Falchook GS, Fu S, Fu S, Amin HM, Amin HM, Piha-Paul SA, Piha-Paul SA, Hong DS, Hong DS, Naing A, Naing A, Klevesath MB, Klevesath MB, Mattiacci MR, Mattiacci MR, Di Cara A, Di Cara A, Kurzrock R, Kurzrock R. A Phase I Dose-escalation Study of EMD 1214063, an Oral Selective C-Met Inhibitor, in Patients With Advanced Solid Tumours. 16th ECCO – 36th ESMO Multidisciplinary Cancer Congress 47(Suppl 1):S158, 2011. e-Pub 2011.
Tsimberidou AM, Iskander NG, Hong DS, Wheler JJ, Fu S, Piha-Paul SA, Naing A, Falchook GS, Janku F, Luthra R, Wen S, Kurzrock R. Personalized medicine in a phase I clinical trials program: The MD Anderson Cancer Center initiative. 2011 ASCO Annual Meeting 29(15S), 2011. e-Pub 2011.
Sun M, Falchook G, Wheler J, Hong D, Piha-Paul S, Tsimberidou A, Naing A, Fu S, Moulder S, Wen S, Mueller P, Kurzrock R. Association of VEGF single-nucleotide polymorphisms (SNPs) with response and toxicity in patients treated with bevacizumab. 2011 ASCO Annual Meeting 29(15S), 2011. e-Pub 2011.
Iwuanyanwu E, Kurzrock R, Piha-Paul S, Wheler J, Falchook G, Mistry R, Tavana B, Lei X, Hong D. Factors influencing a patient's decision to provide a biopsy: Survey of 362 patients in a phase I oncology clinic. 2011 ASCO Annual Meeting 29(15S), 2011. e-Pub 2011.
Stephen B, Wheler JJ, Tsimberidou AM, Wen S, Naing A, Hong DS, Falchook GS, Piha-Paul S, Fu S, Janku F, Moulder SL, Kurzrock R. Survival of 1,181 patients in a phase I clinic: The University of Texas MD Anderson Cancer Center Experience. 2011 ASCO Annual Meeting 29(15S), 2011. e-Pub 2011.
Sun M, Falchook GS, Wheler JJ, Hong DS, Piha-Paul SA, Tsimberidou AM, Naing A, Fu S, Moulder SL, Wen S, Mueller P, Kurzrock R. Association of VEGF single nucleotide polymorphisms (SNPs) with response and toxicity in patients treated with bevacizumab. J Clin Oncol, 2011 ASCO Annual Meeting 29(15S), 2011. e-Pub 2011.
Garrido-Laguna I, Kurzrock R, Wheler JJ, Falchook GS, Piha-Paul SA, Fu S, Naing A, Hinojosa C, Mistry R, Scamardo A, Culotta KS, Ekmekcioglu S, Wen S, Camacho LH, Ivy SP, Hong DS. Dual inhibition of VEGF pathway: phase 1 trial of bevacizumab and cediranib in advanced solid tumors. 2011 ASCO Annual Meeting 29(15S), 2011. e-Pub 2011.
Iwuanyanwu EC, Kurzrock R, Piha-Paul SA, Wheler JJ, Falchook GS, Mistry R, Tavana B, Lei X, Hong DS. Factors influencing patient's decision to provide a biopsy: Survey of 362 patients in a phase I oncology clinic. 2011 ASCO Annual Meeting 29(15S), 2011. e-Pub 2011.
Fok J, Kurzrock R, Tsimberidou AM, Wen S, Naing A, Hong DS, Janku F, Falchook GS, Piha-Paul SA, Katz R, Fu S, Moulder SL, Wheler JJ. An umbrella protocol for histology-independent, phase I modular study based on EGFR mutation status: Using erlotonib alone or in combination with cetuximab, bortezomib, or dasatinib to overcome resistance. 2011 ASCO Annual Meeting 29(15S), 2011. e-Pub 2011.
Wheler JJ, Janku F, Jackson T, Fu S, Sun M, Yang H, Naing A, Moulder SL, Tsimberidou AM, Hong DS, Falchook GS, Piha-Paul SA, Garcia-Manero G, Kurzrock R. Phase I study of anti-VEGF monoclonal antibody bevacizumab and HDAC inhibitor valproic acid in patients with advanced cancers. 2011 ASCO Annual Meeting 29(15S), 2011. e-Pub 2011.
Tsimberidou AM, Hong DS, Wheler J, Fu S, Piha-Paul S, Naing A, Falchook G, Luthra R, Iskander NG, Wen S, Kurzrock R. Initiative for Molecular Profile and Advanced Cancer Therapy (IMPACT): A personalized medicine Phase I clinical trials program at MD Anderson Cancer Center. AACR 102nd Annual Meeting 2011 71(8_Suppl), 2011. e-Pub 2011.
Tsimberidou AM, Hong DS, Wheler JJ, Fu S, Piha-Paul S, Naing A, Falchook GS, Luthra R, Iskander NG, Wen S, Kurzrock R. Profile-related evidence to determine individualized cancer therapy (PREDICT): Preliminary results of the Personalized Phase I Clinical Trials program at MD Anderson Cancer Center. AACR 102nd Annual Meeting 71(8_Suppl), 2011. e-Pub 2011.
Tsimberidou AM, Hong DS, Wheler JJ, Fu S, Piha-Paul S, Naing A, Falchook GS, Luthra R, Iskander NG, Wen S, Kurzrock R. Profile-related evidence to determine individualized cancer therapy (PREDICT): Preliminary results of the Personalized Phase I Clinical Trials program at MD Anderson Cancer Center. AACR 102nd Annual Meeting 71(8_Suppl), 2011. e-Pub 2011.
Wheler J, Tsimberidou A, Wen S, Naing A, Hong D, Falchook G, Piha-Paul S, Fu S, Moulder S, Kurzrock R. Toxicity in 1,181 patients with advanced solid tumors treated in phase I clinical trials of predominantly targeted agents: The MD Anderson Cancer Center experience. J Clin Oncol, ASCO 2010 Annual Meeting 28(15S):230S, 2010. e-Pub 2010.
Janku F, Tsimberidou A, Garrido-Laguna I, Hong D, Naing A, Falchook G, Wheler J, Fu S, Piha-Paul S, Kurzrock R. PIK3CA, KRAS and BRAF mutations in patients with advanced cancers treated with PI3K/AKT/mTOR axis inhibitors. J Clin Oncol, ASCO 2010 Annual Meeting 28(15s):224s, 2010. e-Pub 2010.
Garrido-Laguna I, Janku F, Tsimberidou A, Wheler J, Falchook GS, Fu S, Hong DS, Naing A, Piha-Paul S, Kurzrock R. Phosphatase and tensin homologue (PTEN) loss and response to phase I trials targeting PI3K/AKT/mTOR pathway in patients with advanced cancer. 2010 ASCO Annual Meeting 28(15_Suppl), 2010. e-Pub 2010.
Stephen S, Stephen S, Naing A, Naing A, Hong D, Hong D, Fu S, Fu S, Wheler J, Wheler J, Moulder S, Moulder S, Falchook G, Falchook G, Tsimberidou A, Tsimberidou A, Piha-Paul S, Piha-Paul S, Kurzrock R, Kurzrock R. The use of complementary and alternative medicine in patients seen in phase 1 clinical trials program. 2010 ASCO Annual Meeting 28(15_Suppl):658s, 2010. e-Pub 2010.
Falchook GS, Wheler JJ, Naing DS, Moulder SL, Piha-Paul SA, Ng CS, Jackson E, Kurzrock R. A phase I study of bevacizumab in combination with sunitinib, sorafanib, and erlotinib plus cetuximab, and trastuzumab plus lapatinib. 2010 ASCO Annual Meeting 28(15_Suppl):207s, 2010. e-Pub 2010.

Book Chapters

Ferrarotto R, Goswami S, Marcelo-Lewis K, Piha-Paul SA, Massarelli E. Head and Neck Cancer. In: Handbook of Targeted Cancer Therapy and Immunotherapy. 3rd Edition. Wolters Kluwer, 2022.
Coleman N, Piha-Paul SA. HER2 (ERBB2) Mutations 27. In: Handbook of Targeted Cancer Therapy and Immunotherapy: Breast Cancer. Edition 1. Wolters Kluwer, 2022.
Ferrarotto, Marcelo-Lewis K, Piha-Paul SA, Goswami S, Massarelli E. Head and Neck Cancer. In: Handbook of Targeted Cancer Therapy and Immunotherapy. Second Ed. Wolters Kluwer, 32-34, 2018.

Letters to the Editor

Liu X, Lorusso P, Mita M, Piha-Paul S, Hong DS, Fu S, McQuinn L, Asatiani E, Doyle LA, Chen HX, Hess KR, Kurzrock R, Naing A. Incidence of mucositis in patients treated with temsirolimus-based regimens and correlation to treatment response. Oncologist 19: 426-8, 2014.
Piha-Paul SA, Kurzrock R. Reply to L.D. Locati et al. J Clin Oncol 30: 672-673, 2012.

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CV information above last modified March 06, 2026

Sarina A. Piha-Paul, MD

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Sarina A. Piha-Paul, MD

About Dr. Sarina A. Piha-Paul

In the News

Combining immunotherapy with bacterial injection shows promise in treatment-refractory solid tumors

Present Title & Affiliation

Primary Appointment

Research Interests

Education & Training

Degree-Granting Education

Postgraduate Training

Licenses & Certifications

Experience & Service

Faculty Academic Appointments

Administrative Appointments/Responsibilities

Other Professional Positions

Extramural Institutional Committee Activities

Honors & Awards

Professional Memberships

Selected Presentations & Talks

Local Presentations

National Presentations

International Presentations

Grant & Contract Support

Selected Publications

Peer-Reviewed Articles

Review Articles

Other Articles

Abstracts

Book Chapters

Letters to the Editor

Patient Reviews

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