Piha-Paul, Sarina A. http://orcid.org/0000-0001-9455-1660
Tseng, Chieh
Tran, Hai T.
Gao, Meng
Karp, Daniel D.
Subbiah, Vivek
Tsimberidou, Apostolia Maria
Kawedia, Jitesh D.
Fu, Siqing
Pant, Shubham
Yap, Timothy A.
Morris, Van K.
Kee, Bryan K.
Blum Murphy, Mariela
Lim, JoAnn
Meric-Bernstam, Funda
Clinical trials referenced in this document:
Documents that mention this clinical trial
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
https://doi.org/10.1007/s00280-023-04545-4
Activating HER2 mutations as emerging targets in multiple solid cancers
https://doi.org/10.1136/esmoopen-2017-000279
Funding for this research was provided by:
Puma Biotechnology
Article History
Received: 24 March 2023
Accepted: 9 May 2023
First Online: 14 June 2023
Declarations
:
: SPP reports clinical trial research funding/grant support through the institution from AbbVie, ABM Therapeutics, Acepodia, Alkermes, Aminex Therapeutics, Amphivena Therapeutics, BioMarin Pharmaceutical, Boehringer Ingelheim, Bristol Myers Squib, Cerulean Pharma, Chugai Pharmaceutical, Curis, Cyclacel Pharmaceuticals, Daiichi Sankyo, Eli Lilly, ENB Therapeutics, Epigenetix, Five Prime Therapeutics, F-Star Beta Limited, F-Star Therapeutics, Gene Quantum, Genmab A/S, Gilead Sciences, GlaxoSmithKline, Helix BioPharma, Hengrui Pharmaceuticals, HiberCell, Immorna Biotherapeutics, Immunomedics, Incyte, Jacobio Pharmaceuticals, Jiangsu Simcere Pharmaceutical, Lytix Biopharma AS; Medimmune, Medivation, Merck Sharp and Dohme Corp., Nectin Therapeutics, Novartis Pharmaceuticals, Pieris Pharmaceuticals, Pfizer, Phanes Therapeutics, Principia Biopharma, Puma Biotechnology, Purinomia Biotech, Rapt Therapeutics, Replimune; Seattle Genetics; Silverback Therapeutics; Synlogic Therapeutics; Taiho Oncology; Tesaro, Inc., TransThera Bio, ZielBio, NCI/NIH; P30CA016672 – Core Grant (CCSG Shared Resources) and also worked as a consultant for CRC Oncology. DDK reports research funding/grant support for clinical trials from Pfizer, Phoplatin Therapeutic, Symphogen, NIH clinical translation science award, clinical translation NCI grant and consultancy/advisory board participation for Black Beret Life Science, Affigen and Phosplatin.VS reports research funding/grant support for clinical trials from AbbVie, Agensys, Inc., Alfasigma, Altum, Amgen, Bayer, BERG Health, Blueprint Medicines Corporation, Boston Biomedical, Inc., Boston Pharmaceuticals, Celgene Corporation, D3 Bio, Inc., Dragonfly Therapeutics, Inc., Exelixis, Fujifilm, GlaxoSmithKline, Idera Pharmaceuticals, Inc., Incyte Corporation, Inhibrx, Loxo Oncology, MedImmune, MultiVir, Inc., NanoCarrier, Co., National Comprehensive Cancer Network, NCI-CTEP, Northwest Biotherapeutics, Novartis, PharmaMar, Pfizer, Relay Therapeutics, Roche/Genentech, Takeda, Turning Point Therapeutics, UT MD Anderson Cancer Center, and Vegenics Pty Ltd.; travel support from ASCO, ESMO, Helsinn Healthcare, Incyte Corporation, Novartis, and PharmaMar; consultancy/advisory board participation for Helsinn Healthcare, Jazz Pharmaceuticals, Incyte Corporation, Loxo Oncology/Eli Lilly, MedImmune, Novartis, QED Therapeutics, Relay Therapeutics, Daiichi-Sankyo, and R-Pharm US; and other relationship with Medscape. AT reports research funding/grant support for clinical trials from OBI Pharma USA Inc., Baxalta, Bayer, Boston Biomedical, EMD Serono, Parker Institute for Cancer Immunotherapy, Placon Therapeutics, Agenus, Tempus Labs, Tvardi Therapeutics, Karus Therapeutics, Novocure, NIH/NCI P30CA016672 – Core Grant (CCSG Shared Resources). AT served as consulting or advisory role for Vincerx, Diaccurate. BrYet, NEX-II, Macrogenics. SQF reports research funding/grant support for clinical trials from NIH/NCI P30CA016672 – Core Grant (CCSG Shared Resources), Abbisko, BeiGene, BioAtla, Boehringer Ingelheim, CUE Biopharma, Eli Lilly & Co., Exelisis, Greenfire Bio, Hookipa Biotech, IMV, Innovent Biologics, K-Group Beta, Lyvgen Biopharm, MacroGenics, MediLink Therapeutics, Millennium Pharmaceuticals, Nerviano Medical Sciences, NeuPharma, NextCure, Ningbo NewBay Technology Development, Novartis, NovoCure, Nykode Therapeutics AS., Parexel International, Pionyr Immunotherapeutics, PureTech Health, Sellas Life Sciences Group, Soricimed Biopharma, SQZ Biotechnologies, Sumitomo Dainippon, Taiho Oncology and NCCN; Treadwell Therapeutics, Turnstone Biologics, Tyligand Bioscience, Virogin Biotech. SP reports clinical trial research funding/grant support through the institution from Mirati Therapeutics, Merck, Pfizer, Lilly, Xencor, Novartis, Bristol-Myers Squibb, Ipsen, Astellas, Purple Biotech, 4D Pharma, Boehringer Ingelheim, NGM Biopharmaceuticals, Janssen, Arcus Biosciences, Elicio Therapeutics, Zymeworks, BioNtech and receives personal fees for advisory/consulting from Zymeworks, Ipsen,Novartis, Janssen, Boehringer Ingelheim. TAY reports research funding/grant support for clinical trials from Acrivon, Artios, AstraZeneca, Bayer, Beigene, BioNTech, Blueprint, BMS, Clovis, Constellation, Cyteir, Eli Lilly, EMD Serono, Forbius, F-Star, GlaxoSmithKline, Genentech, Haihe, ImmuneSensor, Ionis, Ipsen, Jounce, Karyopharm, KSQ, Kyowa, Merck, Mirati, Novartis, Pfizer, Ribon Therapeutics, Regeneron, Repare, Rubius, Sanofi, Scholar Rock, Seattle Genetics, Tesaro, Vivace and Zenith, served as a consultant for AbbVie, AstraZeneca, Acrivon, Adagene, Almac, Aduro, Amphista, Artios, Athena, Atrin, Avoro, Axiom, Baptist Health Systems, Bayer, Beigene, Boxer, Bristol Myers Squibb, C4 Therapeutics, Calithera, Cancer Research UK, Clovis, Cybrexa, Diffusion, EMD Serono, F-Star, Genmab, Glenmark, GLG, Globe Life Sciences, GSK, Guidepoint, Idience, Ignyta, I-Mab, ImmuneSensor, Institut Gustave Roussy, Intellisphere, Jansen, Kyn, MEI pharma, Mereo, Merck, Natera, Nexys, Novocure, OHSU, OncoSec, Ono Pharma, Pegascy, PER, Pfizer, Piper-Sandler, Prolynx, Repare, resTORbio, Roche, Schrodinger, Theragnostics, Varian, Versant, Vibliome, Xinthera, Zai Labs and ZielBio and a stockholder in Seagen. VKM discloses research funding (to institution) from EMD Serono, Pfizer, Novartis, Bicara Pharmaceuticals, Bristol Myers Squibb, RedX, and BioNTech. BK declares ownership medtronic corporation stock that is less than $10,000. FM-B reports research funding/grant support for clinical trials from Aileron Therapeutics, AstraZeneca, Bayer Healthcare Pharmaceutical, Calithera Biosciences, Curis, CytomX Therapeutics, Daiichi Sankyo, Debiopharm International, eFFECTOR Therapeutics, Genentech, Guardant Health, Klus Pharma, Takeda Pharmaceutical, Novartis, Puma Biotechnology, Taiho Pharmaceutical. FM-B served as advisory committee for Black Diamond, Biovica, Eisai, FogPharma, Immunomedics, Inflection Biosciences, Karyopharm Therapeutics, Loxo Oncology, Mersana Therapeutics, OnCusp Therapeutics, Puma Biotechnology Inc., Seattle Genetics, Sanofi, Silverback Therapeutics, Spectrum Pharmaceuticals, Zentalis, personal fees for consulting/travel related from AbbVie, Aduro BioTech, Alkermes, AstraZeneca, Daiichi Sankyo, DebioPharm, Ecor1 Capital, eFFECTOR Therapeutics, F. Hoffman-La Roche, GT Apeiron, Genentech, Harbinger Health, IBM Watson, Infinity Pharmaceuticals, Jackson Laboratory, Kolon Life Science, Lengo Therapeutics, Menarini Group, OrigiMed, PACT Pharma, Parexel International, Pfizer, Protai Bio, Samsung Bioepis, Seattle Genetics, Tallac Therapeutics, Tyra Biosciences, Xencor, Zymeworks, European Organisation for Research and Treatment of Cancer (EORTC), European Society for Medical Oncology (ESMO), personal fees for honoraria from Chugai Biopharmaceuticals<b>.</b> No potential conflicts of interest were disclosed by the other authors.
: All participants signed the consent form prior to study enrollment. The study was approved by MD Anderson Institutional Review Board (IRB) in accordance with the Declaration of Helsinki, Good Clinical Practice, and all federal, state and local regulatory guidelines.
: A signed informed consent was obtained from each participant prior to any study procedure.