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Brief Title: Study of ONO-4578 With and Without ONO-4538 in Subjects Advanced or Metastatic Solid Tumors
Official Title: Phase 1 Dose Escalating and Expansion Study of ONO-4578 Given as Monotherapy and Combinations of ONO-4578 and ONO-4538 in Subjects With Advanced or Metastatic Solid Tumors
Study ID: NCT03155061
Brief Summary: The objective of the study is to evaluate the safety, tolerability, pharmacokinetics, efficacy and biomarker of ONO-4578 and combinations of ONO-4578 and ONO-4538 in subjects with advanced or metastatic solid tumors and subjects with unresectable, advanced or recurrent gastric cancer, unresectable, advanced or recurrent colorectal cancer.
Detailed Description:
Minimum Age: 20 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Aichi Clinical Site 1, Nagoya, Aichi, Japan
Aichi Clinical Site 2, Toyoake, Aichi, Japan
Chiba Clinical Site 1, Kashiwa, Chiba, Japan
Ehime Clinical Site1, Matsuyama, Ehime, Japan
Gunma Clinical Site 1, Ota, Gunma, Japan
Hokkaido Clinical Site 1, Sapporo, Hokkaido, Japan
Iwate Clinical Site 1, Yahaba-cho, Iwate, Japan
Kanagawa Clinical Site 2, Sagamihara, Kanagawa, Japan
Kanagawa Clinical Site 1, Yokohama, Kanagawa, Japan
Osaka Clinical Site 2, Hirakata, Osaka, Japan
Osaka Clinical Site 3, Sakai, Osaka, Japan
Osaka Clinical Site 4, Takatsuki, Osaka, Japan
Saitama Clinical Site 2, Hidaka, Saitama, Japan
Saitama Clinical Site 1, Ina-machi, Saitama, Japan
Shizuoka Clinical Site 1, Nagaizumi-Cho, Shizuoka, Japan
Tokyo Clinical Site 1, Chuo-ku, Tokyo, Japan
Tokyo Clinical Site 4, Itabashi-ku, Tokyo, Japan
Tokyo Clinical Site 2, Koto-ku, Tokyo, Japan
Tokyo Clinical Site 3, Shinjyuku-ku, Tokyo, Japan
Fukuoka Clinical Site 1, Fukuoka, , Japan
Fukuoka Clinical Site 2, Fukuoka, , Japan
Osaka Clinical Site 1, Osaka, , Japan
Name: Project Leader
Affiliation: Ono Pharmaceutical Co. Ltd
Role: STUDY_DIRECTOR