A phase 1/1b, open-label, dose-escalation study of PD-1 inhibitor, cetrelimab alone and in combination with FGFR inhibitor, erdafitinib in Japanese patients with advanced solid tumors

Competing interests

Noboru Yamamoto: Research grants as principal investigator (institution): AbbVie, Astellas, AstraZeneca, Bayer, BMS, Boehringer Ingelheim, Carna Biosciences, Chiome Bioscience, Chugai, Cmic, Daiichi-Sankyo, Eisai, Eli Lilly, Genmab, GSK, InventisBio, Janssen, KAKEN, Kyowa Kirin, MERCK, MSD, Novartis, ONO, Otsuka, Pfizer, Rakuten Medical, Shionogi, Sumitomo Pharma, Taiho, Takeda, TORAY. Advisory role: Boehringer Ingelheim, Chugai, Cmic, Eisai, Healios, MERCK, Takeda. Honoraria as speaker: Chugai, Daiichi-Sankyo, Eisai, ONO. Yasutoshi Kuboki: Research grants as principal investigator (institution): Abbie, Amgen, AstraZeneca, Boehringer Ingelheim, Carna Biosciences, Chugai, Daiichi-Sankyo, Genmab, Hengrui, Incyte, Janssen, Lilly, Merk, Novartis, Taiho Astellas, and Takeda. Advisory role: Amgen, Abbie, Boehringer Ingelheim, Incyte, and Takeda. Honoraria as speaker: Lilly, Taiho, and Takeda. Kenichi Harano: Research grants as principal investigator (institution): Astra Zeneca, Daiichi-Sankyo, MERCK, MSD, Takeda. Advisory role: Astra Zeneca, Chugai, Taiho, Takeda. Honoraria as speaker: Astra Zeneca, Chugai, Eizai, MSD, Taiho, Takeda. Takafumi Koyama: Honoraria as speakers: AstraZeneca, Chugai, Novartis, and Sysmex. Research grants as principal investigator (institution): Chugai, Daiichi-Sankyo, Eli Lilly, Janssen, Novartis, PACT Pharma, Pfizer, Takeda and Zymeworks. Shunsuke Kondo: Research grants as principal investigator (institution): AbbVie, Astellas, AstraZeneca, Boehringer Ingelheim, Chugai, Incyte, Eisai, Eli Lilly. Advisory role: Sanofi. Honoraria as speaker: Chugai, Eisai, Incyte, Takeda. Akiko Hagiwara, Noriko Suzuki, Ei Fujikawa, Kiichiro Toyoizumi, and Mayumi Mukai: Employees of Janssen Pharmaceutical K.K. and hold company stocks. Toshihiko Doi: Research grants as principal investigator (institution): Abbvie, Amgen, Boehringer Ingelheim, Bristol-Myers Squibb, Chugai Pharmaceutical, Daiichi-Sankyo, Dainippon Sumitomo Pharma, Eisai, GSK, Janssen, MSD, Novartis, ONO PHARMACEUTICAL, Pfizer, PRA Health Science, SHIONOGI, and TAIHO PHARMACEUTICAL. Advisory role: A2 Health Care, Boehringer Ingelheim, Chugai Pharma, Janssen, KAKEN Pharma, KYOWA KIRIN, Mitsubishi Tanabe Pharma, Nano Carrier, Noil-Immube Biotech, Oncolys BioPharma, Otsuka Pharma, PRA Health Science, Rakuten Medical, SHIONOGI, Sumitomo Pharma, and Takeda Pharma. Honoraria as speaker: Daiichi-Sankyo.

Ethics approval

The study protocol and associated study documents were approved by the Institutional Review Board. Good Clinical Practice (GCP) guidelines, established by the International Council for Harmonization (ICH) and all relevant regulatory requirements were followed during the conduct of this study.

Consent to participate

All patients gave their informed consent prior to being enrolled in the study.

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