Advanced or Metastatic Solid Tumors Clinical Trial
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
| Verified date | May 2024 |
| Source | Ono Pharmaceutical Co. Ltd |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Active, not recruiting |
| Enrollment | 183 |
| Est. completion date | September 2025 |
| Est. primary completion date | September 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 20 Years and older |
| 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 |
| Country | Name | City | State |
|---|---|---|---|
| Japan | Tokyo Clinical Site 1 | Chuo-ku | Tokyo |
| Japan | Fukuoka Clinical Site 1 | Fukuoka | |
| Japan | Fukuoka Clinical Site 2 | Fukuoka | |
| Japan | Saitama Clinical Site 2 | Hidaka | Saitama |
| Japan | Osaka Clinical Site 2 | Hirakata | Osaka |
| Japan | Saitama Clinical Site 1 | Ina-machi | Saitama |
| Japan | Tokyo Clinical Site 4 | Itabashi-ku | Tokyo |
| Japan | Chiba Clinical Site 1 | Kashiwa | Chiba |
| Japan | Tokyo Clinical Site 2 | Koto-ku | Tokyo |
| Japan | Ehime Clinical Site1 | Matsuyama | Ehime |
| Japan | Shizuoka Clinical Site 1 | Nagaizumi-Cho | Shizuoka |
| Japan | Aichi Clinical Site 1 | Nagoya | Aichi |
| Japan | Osaka Clinical Site 1 | Osaka | |
| Japan | Gunma Clinical Site 1 | Ota | Gunma |
| Japan | Kanagawa Clinical Site 2 | Sagamihara | Kanagawa |
| Japan | Osaka Clinical Site 3 | Sakai | Osaka |
| Japan | Hokkaido Clinical Site 1 | Sapporo | Hokkaido |
| Japan | Tokyo Clinical Site 3 | Shinjyuku-ku | Tokyo |
| Japan | Osaka Clinical Site 4 | Takatsuki | Osaka |
| Japan | Aichi Clinical Site 2 | Toyoake | Aichi |
| Japan | Iwate Clinical Site 1 | Yahaba-cho | Iwate |
| Japan | Kanagawa Clinical Site 1 | Yokohama | Kanagawa |
| Lead Sponsor | Collaborator |
|---|---|
| Ono Pharmaceutical Co. Ltd |
Japan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | ||
| Secondary | Maximum observed serum concentration(Cmax) | Up to Cycle 1 (each cycle is 28 days) | ||
| Secondary | Area Under the blood concentration-time Curve(AUC) | Up to Cycle 1 (each cycle is 28 days) | ||
| Secondary | Half-life(T1/2) of ONO-4578 both alone and in combination with ONO-4538 | Up to Cycle 1 (each cycle is 28 days) |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
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