A phase I study of ATR inhibitor gartisertib (M4344) as a single agent and in combination with carboplatin in patients with advanced solid tumours

Competing interests

HAB: received institutional study grants from Abbvie, Agios, ARMO Biosciences, Array BioPharma, Arvinas, AstraZeneca, Bayer, Beigene, BioAtla, BioMed Valley Discoveries, BioTheryX, Boehringer Ingelheim, Bristol-Myers Squibb, CALGB, Celgene CicloMed, Coordination Pharmaceuticals, eFFECTOR Therapeutics, Lilly, EMD Serono Research & Development Institute, Inc., Billerica, MA, USA, an affiliate of Merck KGaA, Roche/Genentech, GlaxoSmithKline, Grossamer Bio, Harpoon Therapeutics, Hengrui Therapeutics, Incyte, Janssen, Jounce Therapeutics, Kymab, MacroGenics, MedImmune, MSD., Millennium, Moderna, NGM Biopharmaceuticals, Novartis, Pfizer, Revolution Medicines, Ryvu Therapeutics, Foundation Medicine, SeaGen, Tesaro, TG Therapeutics, Verastem, Vertex Pharmaceuticals, XBiotech, and Zymeworks; has received consulting fees from Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Incyte, Novartis, TG Therapeutics (all of which were non-compensated) as well as GRAIL, Roche, and Vincerx Pharma (which were paid to his institution); and has stock or stock options in HCA Healthcare. JB: grants or contracts to institution from Bayer, AbbVie (Pharmacyclics), Novartis (Array), Karyopharm, Lilly, Incyte, Immunomedics, Boston Biomedical, Pfizer, Symphogen, FivePrime, EMD Serono Research & Development Institute, Inc., Billerica, MA, USA, an affiliate of Merck KGaA, I-Mab, Dragonfly, PsiOxus, Transcenta Therapeutics, Sumitomo Dainippon Pharma Oncology, 23 and me, Atreca, Astellas, BMS, and Tyra; has participated in advisory boards for EMD Serono Research & Development Institute, Inc., Billerica, MA, USA, an affiliate of Merck KGaA, Ipsen, QED, Clovis, Bayer, Mirati, and Eisai, Oxford Biotherapeutics, Biosapiens, Insmed, Boehringer Ingelheim, Merus; and has participated on data and safety monitoring boards for Astra Zeneca, and Novocure. TA: received institutional study grants from Astra Zeneca, Roche, Lilly, Bayer, GSK, Amgen, and Pfizer. GMC: support paid to his institution for the conduct of clinical trials from Servier Pharmaceuticals; advisory board fees and support paid to his institution for the conduct of clinical trials from Epizyme; advisory board fees, compound, and support paid to his institution for the conduct of clinical trials PharmaMar; support paid to his institution for the conduct of clinical trials from Macrogenics; advisory board fees, compound, and support paid to his institution for the conduct of clinical trials from Eisai; compound and support paid to his institution for the conduct of clinical trials from Merck/EMD Serono Research and Development Institute, an affiliate of Merck KGaA; support paid to his institution for the conduct of clinical trials from Bavarian-Nordic; compound for preclinical research and support paid to his institution for the conduct of clinical trials from Bayer; support paid to his institution for the conduct of clinical trials from SpringWorks Therapeutics; support paid to his institution for the conduct of clinical trials from Repare Therapeutics; advisory board fees and support paid to his institution for the conduct of clinical trials from Foghorn; support paid to his institution for the conduct of clinical trials from SMP Oncology; compound and support paid to his institution for the conduct of clinical trials from Jazz Pharmaceuticals; support paid to his institution for the conduct of clinical trials from RAIN Therapeutics; support paid to his institution for the conduct of clinical trials from BioAtla; support paid to his institution for the conduct of clinical trials from Inhibrx; advisory board fees and support paid to his institution for the conduct of clinical trials from Ikena; advisory board fees and support paid to his institution for the conduct of clinical trials from C4 Therapeutics; advisory board fees from Daiichi Sankyo, Inc. MPL: is an employee of Amgen Inc., Thousand Oaks, CA, USA and has previously received institutional research funding from Sanofi, Johnson and Johnson, MSD, and Astellas and has received consulting fees from Incyte, Amgen, Janssen Cilag B.V., Bayer, Servier, Roche, Pfizer, Sanofi Aventis Netherlands BV and Astellas. JF-P is an employee of Ares Trading SA., Eysins, Switzerland, an affiliate of Merck KGaA. AK and TG are employees of Merck Healthcare KGaA, Darmstadt, Germany. JB is an employee of EMD Serono Research & Development Institute, Inc., Billerica, MA, USA, an affiliate of Merck KGaA. GL is an employee of Merck Healthcare KGaA, Darmstadt, Germany. IG is an employee of Merck Serono Ltd., Feltham, UK, an affiliate of Merck KGaA, and holds stocks/shares in Novartis and Alcon. JdB: Advisory boards for Amgen, Astellas, AstraZeneca, Bayer, Bioxcel Therapeutics, Boehringer Ingelheim, Cellcentric, Daiichi, Eisai, Genentech Roche, Genmab, GSK, Harpoon, Janssen, EMD Serono Research & Development Institute, Inc., Billerica, MA, USA, an affiliate of Merck KGaA, MSD, Orion Pharma, Pfizer, Qiagen, Sanofi Aventis, Sierra Oncology, Taiho, Terumo and Vertex Pharmaceuticals; has received research grants from Bayer, Cellcentric, Daiichi, Genentech Roche, GSK, Harpoon Janssen, MSD, Orion Pharma, Pfizer, Sanofi Aventis, Sierra Oncology, Taiho, Vertex Pharmaceuticals, Crescendo Biologics; has held a principal investigator role for Amgen, Astellas, AstraZeneca, Bayer, Bioxcel Therapeutics, Boehringer Ingelheim, Cellcentric, Daiichi, Eisai, Genentech Roche, Genmab, GSK, Harpoon Janssen, Menarini Silicon Biosystems, EMD Serono Research & Development Institute, Inc., Billerica, MA, USA, an affiliate of Merck KGaA, MSD, Orion Pharma, Pfizer, Qiagen, Sanofi Aventis, Sierra Oncology, Taiho, Terumo and Vertex Pharmaceuticals and has received product samples from Daiichi, Bayer, AstraZeneca, Harpoon, Pfizer, Sierra Oncology, Genentech Roche, Sanofi Aventis and GSK.

Ethics approval and consent to participate

This study was performed in compliance with the International Council for Harmonisation Good Clinical Practice guideline and in accordance with the Declaration of Helsinki. The study protocol and other relevant documents were reviewed and approved by an Institutional Review Board/Independent Ethics Committee before study start and all patients provided their written informed consent.

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