Study of ONO-4578 With and Without ONO-4538 in Subjects Advanced or Metastatic Solid Tumors
- Conditions
- Advanced or Metastatic Solid Tumors
- Interventions
- Registration Number
- NCT03155061
- Lead Sponsor
- Ono Pharmaceutical Co. Ltd
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 183
- 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
- Patients with severe complication
- Patients with multiple primary cancers
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part B: ONO-4578 in combination with ONO-4538 ONO-4538 ONO-4578+ONO-4538 specified dose on specified days in advanced or metastatic solid tumors Part C (Expansion Part): ONO-4578 in combination with ONO-4538 ONO-4578 ONO-4578+ONO-4538 specified dose on specified days in unresectable, advanced or recurrent gastric cancer Part C (Expansion Part): ONO-4578 in combination with ONO-4538 ONO-4538 ONO-4578+ONO-4538 specified dose on specified days in unresectable, advanced or recurrent gastric cancer Part A (Dose Escalation Part): ONO-4578 monotherapy ONO-4578 ONO-4578 specified dose on specified days in advanced or metastatic solid tumors Part D (Expansion Part): ONO-4578 in combination with ONO-4538 ONO-4538 ONO-4578+ONO-4538 specified dose on specified days in unresectable, advanced or recurrent colorectal cancer Part B: ONO-4578 in combination with ONO-4538 ONO-4578 ONO-4578+ONO-4538 specified dose on specified days in advanced or metastatic solid tumors Part D (Expansion Part): ONO-4578 in combination with ONO-4538 ONO-4578 ONO-4578+ONO-4538 specified dose on specified days in unresectable, advanced or recurrent colorectal cancer
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Area Under the blood concentration-time Curve(AUC) Up to Cycle 1 (each cycle is 28 days) Maximum observed serum concentration(Cmax) Up to Cycle 1 (each cycle is 28 days) Half-life(T1/2) of ONO-4578 both alone and in combination with ONO-4538 Up to Cycle 1 (each cycle is 28 days)
Trial Locations
- Locations (22)
Aichi Clinical Site 1
🇯🇵Nagoya, Aichi, Japan
Osaka Clinical Site 4
🇯🇵Takatsuki, Osaka, Japan
Aichi Clinical Site 2
🇯🇵Toyoake, Aichi, Japan
Osaka Clinical Site 2
🇯🇵Hirakata, Osaka, Japan
Osaka Clinical Site 3
🇯🇵Sakai, Osaka, Japan
Kanagawa Clinical Site 1
🇯🇵Yokohama, Kanagawa, Japan
Hokkaido Clinical Site 1
🇯🇵Sapporo, Hokkaido, Japan
Saitama Clinical Site 2
🇯🇵Hidaka, Saitama, Japan
Fukuoka Clinical Site 2
🇯🇵Fukuoka, Japan
Ehime Clinical Site1
🇯🇵Matsuyama, Ehime, Japan
Chiba Clinical Site 1
🇯🇵Kashiwa, Chiba, Japan
Gunma Clinical Site 1
🇯🇵Ota, Gunma, Japan
Iwate Clinical Site 1
🇯🇵Yahaba-cho, Iwate, Japan
Kanagawa Clinical Site 2
🇯🇵Sagamihara, Kanagawa, Japan
Saitama Clinical Site 1
🇯🇵Ina-machi, Saitama, Japan
Osaka Clinical Site 1
🇯🇵Osaka, Japan
Shizuoka Clinical Site 1
🇯🇵Nagaizumi-Cho, Shizuoka, Japan
Tokyo Clinical Site 2
🇯🇵Koto-ku, Tokyo, Japan
Tokyo Clinical Site 3
🇯🇵Shinjyuku-ku, Tokyo, Japan
Tokyo Clinical Site 4
🇯🇵Itabashi-ku, Tokyo, Japan
Tokyo Clinical Site 1
🇯🇵Chuo-ku, Tokyo, Japan
Fukuoka Clinical Site 1
🇯🇵Fukuoka, Japan