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Study of ONO-4578 With and Without ONO-4538 in Subjects Advanced or Metastatic Solid Tumors
Sponsor: Ono Pharmaceutical Co. Ltd
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.
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
Key Details
Gender
All
Age Range
20 Years - Any
Study Type
INTERVENTIONAL
Enrollment
183
Start Date
2017-04-19
Completion Date
2027-03
Last Updated
2025-06-05
Healthy Volunteers
No
Conditions
Interventions
ONO-4578
ONO-4578 specified dose on specified days
ONO-4538
ONO-4538 specified dose on specified days
Locations (22)
Aichi Clinical Site 1
Nagoya, Aichi-ken, Japan
Aichi Clinical Site 2
Toyoake, Aichi-ken, Japan
Chiba Clinical Site 1
Kashiwa, Chiba, Japan
Ehime Clinical Site1
Matsuyama, Ehime, Japan
Gunma Clinical Site 1
Ōta, 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