NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

Active Not RecruitingPhase 1

Sponsor: Ono Pharmaceutical Co., Ltd.

Conditions: Advanced or Metastatic Solid Tumors

Interventions: ONO-4578, ONO-4538

Countries: Japan

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.

Eligibility overview

Sex: ALL

Age: 20 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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:

* Patients with severe complication
* Patients with multiple primary cancers

Locations (22)

Nagoya, Aichi-ken, Japan
Toyoake, Aichi-ken, Japan
Kashiwa, Chiba, Japan
Matsuyama, Ehime, Japan
Fukuoka, Fukuoka, Japan
Fukuoka, Fukuoka, Japan
Ōta, Gunma, Japan
Sapporo, Hokkaido, Japan
Yahaba-cho, Iwate, Japan
Sagamihara, Kanagawa, Japan
Yokohama, Kanagawa, Japan
Hirakata, Osaka, Japan
Osaka, Osaka, Japan
Sakai, Osaka, Japan
Takatsuki, Osaka, Japan
Hidaka, Saitama, Japan
Ina-machi, Saitama, Japan
Nagaizumi-Cho, Shizuoka, Japan
Chuo-ku, Tokyo, Japan
Itabashi-ku, Tokyo, Japan
Koto-ku, Tokyo, Japan
Shinjyuku-ku, Tokyo, Japan