Clinical Trials in Japan / NCT03155061
Active, not recruiting
Phase 1
Study of ONO-4578 With and Without ONO-4538 in Subjects Advanced or Metastatic Solid Tumors
NCT03155061 · tracked via the Priya Life Science Japan tracker
Condition(s) studied
Advanced or Metastatic Solid Tumors
Investigational drug(s) / intervention(s)
ONO-4578: ONO-4578 specified dose on specified days
ONO-4538: ONO-4538 specified dose on specified days
Study 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.
Eligibility
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
Primary outcome measure(s)
- Evaluation of the safety (adverse event, clinical laboratory test, 12-lead electrocardiography, chest X-ray, ECOG performance status) — Through study completion, an average of 1 year
Trial sites (22)
| Facility | City | Region | Status |
|---|---|---|---|
| Aichi Clinical Site 1 | Nagoya | Aichi-ken | |
| Aichi Clinical Site 2 | Toyoake | Aichi-ken | |
| Chiba Clinical Site 1 | Kashiwa | Chiba | |
| Ehime Clinical Site1 | Matsuyama | Ehime | |
| Fukuoka Clinical Site 1 | Fukuoka | Fukuoka | |
| Fukuoka Clinical Site 2 | Fukuoka | Fukuoka | |
| Gunma Clinical Site 1 | Ōta | Gunma | |
| Hokkaido Clinical Site 1 | Sapporo | Hokkaido | |
| Iwate Clinical Site 1 | Yahaba-cho | Iwate | |
| Kanagawa Clinical Site 2 | Sagamihara | Kanagawa | |
| Kanagawa Clinical Site 1 | Yokohama | Kanagawa | |
| Osaka Clinical Site 2 | Hirakata | Osaka | |
| Osaka Clinical Site 1 | Osaka | Osaka | |
| Osaka Clinical Site 3 | Sakai | Osaka | |
| Osaka Clinical Site 4 | Takatsuki | Osaka | |
| Saitama Clinical Site 2 | Hidaka | Saitama | |
| Saitama Clinical Site 1 | Ina-machi | Saitama | |
| Shizuoka Clinical Site 1 | Nagaizumi-Cho | Shizuoka | |
| Tokyo Clinical Site 1 | Chuo-ku | Tokyo | |
| Tokyo Clinical Site 4 | Itabashi-ku | Tokyo | |
| Tokyo Clinical Site 2 | Koto-ku | Tokyo | |
| Tokyo Clinical Site 3 | Shinjyuku-ku | Tokyo |
More Ono Pharmaceutical Co., Ltd. trials in Japan
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The Study of ONO-7913, ONO-4538 and the Standard of Care as First-line Treatment in Patients Colorectal Cancer
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A Phase I Study of ONO-4538HSC in Subjects With Advanced or Metastatic Solid Tumors
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Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT03155061 on ClinicalTrials.gov ↗ ← All trials in Japan