{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,1]],"date-time":"2026-10-01T07:05:47Z","timestamp":1790838347115,"version":"4.1.0"},"reference-count":15,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2024,1,11]],"date-time":"2024-01-11T00:00:00Z","timestamp":1704931200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2024,1,11]],"date-time":"2024-01-11T00:00:00Z","timestamp":1704931200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/100010795","name":"Chugai Pharmaceutical Co., Ltd.","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100010795","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Cancer Chemother Pharmacol"],"published-print":{"date-parts":[[2024,7]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n                <jats:title>Purpose<\/jats:title>\n                <jats:p>Tiragolumab is a monoclonal antibody that binds to the inhibitory immune checkpoint TIGIT (T-cell immunoreceptor with Ig and ITIM domains). In early phase clinical trials, tiragolumab in combination with the programmed death-ligand 1-inhibitor atezolizumab was well tolerated and has demonstrated preliminary anti-tumor activity in patients with advanced\/metastatic solid tumors. We report the results of a phase I study of tiragolumab plus atezolizumab in Japanese patients (jRCT2080224926).<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>Japanese patients\u2009\u2265\u200920\u00a0years old received tiragolumab (600\u00a0mg) and atezolizumab (1200\u00a0mg) intravenously every 21\u00a0days until unacceptable toxicity or disease progression. Primary endpoints were safety and pharmacokinetic (PK) parameters of tiragolumab plus atezolizumab. Secondary endpoints were anti-tumor activity.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>Three patients were enrolled with diagnoses of non-small cell lung cancer, pancreatic cancer, and cholangiocarcinoma. No dose-limiting toxicities were observed. Two patients experienced treatment-related adverse events (AEs) of any grade. There were no grade\u2009\u2265\u20093 AEs, serious AEs, AEs leading to discontinuation, modification or withdrawal of any study drug, or AEs leading to death. At cycle 1, mean PK parameters of tiragolumab were as follows: C<jats:sub>max<\/jats:sub> 217\u00a0\u03bcg\/mL; C<jats:sub>min<\/jats:sub> 54.9\u00a0\u03bcg\/mL; area under the concentration\u2013time curve from 0 to the last measurable concentration, 2000\u00a0\u03bcg\u00b7day\/mL; t<jats:sub>1\/2<\/jats:sub>, 17.6\u00a0days. Best overall response was stable disease in two patients.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusion<\/jats:title>\n                <jats:p>Tiragolumab plus atezolizumab was well tolerated in Japanese patients with advanced\/metastatic solid tumors, and no differences in tiragolumab PK characteristics were noted between Japanese patients enrolled in this study, and non-Japanese patients enrolled in a global phase Ia\/Ib study. These results may support the inclusion of Japanese patients in ongoing global phase III clinical trials.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Trial registration number<\/jats:title>\n                <jats:p>jRCT2080224926.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1007\/s00280-023-04627-3","type":"journal-article","created":{"date-parts":[[2024,1,11]],"date-time":"2024-01-11T16:02:22Z","timestamp":1704988942000},"page":"109-115","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":17,"title":["Phase I study of the anti-TIGIT antibody tiragolumab in combination with atezolizumab in Japanese patients with advanced or metastatic solid tumors"],"prefix":"10.1007","volume":"94","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-0787-2851","authenticated-orcid":false,"given":"Noboru","family":"Yamamoto","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takafumi","family":"Koyama","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jun","family":"Sato","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tatsuya","family":"Yoshida","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kazuki","family":"Sudo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Satoru","family":"Iwasa","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shunsuke","family":"Kondo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kan","family":"Yonemori","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Atsuko","family":"Kawasaki","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kyoko","family":"Satake","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shoyo","family":"Shibata","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Toshio","family":"Shimizu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2024,1,11]]},"reference":[{"issue":"2","key":"4627_CR1","doi-asserted-by":"publisher","first-page":"39","DOI":"10.1208\/s12248-021-00574-0","volume":"23","author":"JD Twomey","year":"2021","unstructured":"Twomey JD, Zhang B (2021) Cancer immunotherapy update: FDA-approved checkpoint inhibitors and companion diagnostics. 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Noboru Yamamoto also declares honoraria from AstraZeneca, Eli Lilly, ONO, Chugai, Sysmex, Daiichi-Sankyo, Eisai and research funding from Astellas, Chugai Pharmaceutical Co., Ltd., Eisai, Taiho, Bristol\u2013Myers Squibb, Pfizer, Novartis, Eli Lilly, AbbVie, Daiichi-Sankyo, Bayer, Boehringer Ingelheim, Kyowa-Hakko Kirin, Takeda, ONO, Janssen Pharma, MSD, MERCK, GSK, Sumitomo Dainippon, Chiome Bioscience, Otsuka, Carna Biosciences, Genmab, Shionogi and TORAY. Takafumi Koyama declares honoraria from Sysmex and Chugai Pharmaceutical Co., Ltd., and research funding from PACT Pharma, Chugai Pharmaceutical Co., Ltd., Lilly, Novartis, Takeda, and Daiichi-Sankyo. Jun Sato declares receipt of lecture fees from Chugai Pharmaceutical Co., Ltd. Tatsuya Yoshida declares honoraria from Pfizer, Takeda, AstraZeneca, TAIHO, Chugai Pharmaceutical Co., Ltd., Novartis, Lilly, MSD, Ono Pharmaceutical, Roche, and Bristol\u2013Myers Squibb; and research funding from AMGEN, AstraZeneca, Takeda, Chugai Pharmaceutical Co., Ltd., Novartis, Daiichi-Sankyo, Ono Pharmaceutical, AbbVie, Blueprint, and Bristol\u2013Myers Squibb. Kazuki Sudo declares no conflict of interest. Satoru Iwasa declares receipt of lecture fees from Chugai Pharmaceutical Co., Ltd. Shunsuke Kondo declares honoraria from Eisai, Incyte and Chugai Pharmaceutical Co., Ltd.; and research funding from Astellas, Incyte, AstraZeneca, MSD, Daiichi-Sankyo, Eisai, AbbVie, Lilly and Bristol\u2013Myers Squibb. Kan Yonemori declares advisory roles at Novartis, Eisai, AstraZeneca, Chugai Pharmaceutical Co., Ltd., Takeda, Genmab, and OncXerna; honoraria from Pfizer, Eisai, AstraZeneca, Eli Lilly, Takeda, Chugai Pharmaceutical Co., Ltd., Fuji Film Pharma, MSD, Boehringer Ingelheim, Ono, and Daiichi-Sankyo; and research funding from AstraZeneca, Taiho, Pfizer, Novartis, Takeda, Chugai Pharmaceutical Co., Ltd., Ono, Sanofi, Seattle Genetics, Eisai, Eli Lilly, Genmab, Boehringer Ingelheim, and Kyowa Hakko. Atsuko Kawasaki, Shoyo Shibata and Kyoko Satake are employees of Chugai Pharmaceutical Co., Ltd. Toshio Shimizu declares employment\/leadership\/advisory role from AbbVie, Daiichi-Sankyo and Chordia Therapeutics and honoraria from Eli Lilly, MSD and Chugai. Toshio Shimizu also declares research funding from Novartis, Eli Lilly, AbbVie, Daiichi-Sankyo, Bristol-Myers Squibb,\u00a0Eisai, AstraZeneca, Takeda Oncology, Incyte, Chordia Therapeutics, 3D-Medicine, Symbio Pharmaceuticals, PharmaMar, Pfizer, Five Prime and Astellas Pharma.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"The study protocol was reviewed and approved by the institutional review board or independent ethics committee at the study center, and the study was conducted according to the ethical principles of the Declaration of Helsinki.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical approval"}},{"value":"All patients provided written informed consent.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Informed consent"}}]}}