A first-in-human phase I study of TAS-117, an allosteric AKT inhibitor, in patients with advanced solid tumors

Conflict of interest

TD has received institutional grants or contracts from PRA Health Sciences, MSD, Daiichi Sankyo, Amgen, Taiho, GSK, ONO Pharma, Janssen Pharma, Boehringer Ingelheim, Pfizer, BMS, Abbvie, Eisai, RIN Institute, Chugai Pharma, and SHIONOGI; consulting fees from Sumitomo Pharma, Oncolys BioPharma, Takeda, Chugai Pharma, Boehringer Ingelheim, Nano Carrier, Rakuten Medical, Otsuka Pharma, KAKEN Pharma, KYOWA KIRIN, SHIONOGI, PRA Health Science, A2 Health Care, and Noil-Immune Biotech; payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Daiichi Sankyo; and has participated on a Data Safety Monitoring Board or Advisory Board for Gilead, Pfizer, Amgen, and ZYMEWORKS BIOPHARMA. ST has received institutional grants from Astellas, Bayer, Chugai, Daiichi Sankyo, Eisai, Eli Lilly, MSD, Novartis, Ono, Sanofi, and Taiho; and honoraria from Astellas, Bayer, Chugai, Daiichi Sankyo, Eisai, MSD, Ono, Sanofi, and Taiho. DA has received honoraria from AstraZeneca, Chugai, Eisai, Genmab, MSD, Myriad Genetics, and Takeda. KY has received honoraria from Pfizer, Eisai, AstraZeneca, Eli Lilly, Takeda, Chugai, Fuji Film Pharma, PDR pharma, MSD, Boehringer Ingelheim, Ono, Daiichi Sankyo, Bayer, Janssen, and Sanofi; served on the advisory boards of Eisai, AstraZeneca, Sanofi, Genmab, Gilead, OncXerna, Takeda, Novartis, and MSD; and has received institutional research grants and been a Principal Investigator for MSD, Daiichi Sankyo, AstraZeneca, Taiho, Pfizer, Novartis, Takeda, Chugai, Ono, Sanofi, Seattle Genetics, Eisai, Eli Lilly, Genmab, Boehringer Ingelheim, Kyowa Hakko Kirin, Nihon Kayaku, and Haihe. HH has received honoraria from Bayer, Bristol-Myers Squibb, Chugai, Daiichi Sankyo, Kyowa Hakko Kirin, Lilly, Merck Biopharma, MSD, Ono, Taiho, Takeda, and Yakult; held consulting or advisory roles for Bristol-Myers Squibb, Boehringer Ingelheim, and Daiichi Sankyo; and received research grants from ALX Oncology, Amgen, Astellas, AstraZeneca, Bayer, BeiGene, Boehringer Ingelheim, Bristol-Myers Squibb, Chugai, Daiichi Sankyo, Eisai, Janssen, Merck Biopharma, MSD, Ono, and Taiho. KHasegawa has received consultancy fees from Takeda, MSD, Sanofi, and Eisai; institutional grants from Takeda, MSD, and Ono; honoraria from AstraZeneca, Takeda, MSD, Sanofi, Chugai, Eisai, and Genmab; and travel/accommodation expenses from Regeneron. KT has received honoraria from Taiho Pharmaceutical Co. Ltd. KHarano has received consultancy fees from Taiho and Takeda; institutional grants from Merck and Daiichi-Sankyo; and payment for development of educational presentations including service on speakers' bureaus from AstraZeneca, Chugai, MSD, Taiho, and Takeda. MY has received honoraria from Taiho Pharmaceutical Co., Ltd, AstraZeneca, Takeda Pharmaceutical Co., MSD, Merck, Chugai Pharmaceutical Co., Mochida Pharmaceutical Co., and Eisai Pharmaceutical Co. HN, TS, KHorie, AO, and SO have no conflicts of interest to declare.

Ethical approval

This study was conducted in accordance with the study protocol, Good Clinical Practice guidelines, International Council for Harmonisation Guidelines, the ethical principles originating in the Declaration of Helsinki, and all applicable regulatory requirements.

Informed consent

Informed consent was obtained from all individual participants included in the study.

Consent to publish

Patients signed informed consent regarding publishing their data.

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