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

Program Status

Active, not recruiting

Phase

Phase 1

Prior Immunotherapy Allowed

Yes

CRC-directed Trial

No

Drugs

ONO-4538, ONO-4578, Opdivo

Tags

MSS/ MMRp

Comments

Two arm study:
First arm: ONO-4578 (EP4 antagonist) monotherapy
Second arm: ONO-4578 (EP4 antagonist) combination with ONO-4538 (PD1, Nivolumab, Opdivo)

Location Location Status
Japan
Aichi Clinical Site 1
Nagoya, Aichi
Active, not recruiting
Aichi Clinical Site 2
Toyoake, Aichi
Active, not recruiting
Chiba Clinical Site 1
Kashiwa, Chiba
Active, not recruiting
Ehime Clinical Site1
Matsuyama, Ehime
Active, not recruiting
Gunma Clinical Site 1
Ota, Gunma
Active, not recruiting
Hokkaido Clinical Site 1
Sapporo, Hokkaido
Active, not recruiting
Iwate Clinical Site 1
Yahaba-cho, Iwate
Active, not recruiting
Kanagawa Clinical Site 2
Sagamihara, Kanagawa
Active, not recruiting
Kanagawa Clinical Site 1
Yokohama, Kanagawa
Active, not recruiting
Osaka Clinical Site 2
Hirakata, Osaka
Active, not recruiting
Osaka Clinical Site 3
Sakai, Osaka
Active, not recruiting
Osaka Clinical Site 4
Takatsuki, Osaka
Active, not recruiting
Saitama Clinical Site 2
Hidaka, Saitama
Active, not recruiting
Saitama Clinical Site 1
Ina-machi, Saitama
Active, not recruiting
Shizuoka Clinical Site 1
Nagaizumi-Cho, Shizuoka
Active, not recruiting
Tokyo Clinical Site 1
Chuo-ku, Tokyo
Active, not recruiting
Tokyo Clinical Site 4
Itabashi-ku, Tokyo
Active, not recruiting
Tokyo Clinical Site 2
Koto-ku, Tokyo
Active, not recruiting
Tokyo Clinical Site 3
Shinjyuku-ku, Tokyo
Active, not recruiting
Fukuoka Clinical Site 1
Fukuoka
Active, not recruiting
Fukuoka Clinical Site 2
Fukuoka
Active, not recruiting
Osaka Clinical Site 1
Osaka
Active, not recruiting

Inclusion Criteria

Inclusion Criteria:

* Advanced or metastatic solid tumors (Part A, B)
* Unresectable, advanced or recurrent gastric cancer previously treated with anti-PD-(L)1 antibodies or naive to anti-PD-(L)1 antibodies (Part C)
* Unresectable, advanced or recurrent colorectal cancer(Part D)
* Life expectancy of at least 3 months
* Patients with ECOG performance status 0 or 1

Exclusion Criteria

Exclusion Criteria:

* Patients with severe complication
* Patients with multiple primary cancers

NCT ID

NCT03155061

Date Trial Added

2017-05-16

Updated Date

2024-08-23