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ACTIVE NOT RECRUITING
NCT03155061
PHASE1

Study of ONO-4578 With and Without ONO-4538 in Subjects Advanced or Metastatic Solid Tumors

Sponsor: Ono Pharmaceutical Co. Ltd

View on ClinicalTrials.gov

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

Interventions

DRUG

ONO-4578

ONO-4578 specified dose on specified days

DRUG

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