Study of ONO-4578 With and Without ONO-4538 in Subjects Advanced or Metastatic Solid Tumors
Phase 1
Active, not recruiting
- Conditions
- Advanced or Metastatic Solid Tumors
- Registration Number
- NCT03155061
- Lead Sponsor
- Ono Pharmaceutical Co. Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Inclusion Criteria:<br><br> - Advanced or metastatic solid tumors (Part A, B)<br><br> - Unresectable, advanced or recurrent gastric cancer previously treated with<br> anti-PD-(L)1 antibodies or naive to anti-PD-(L)1 antibodies (Part C)<br><br> - Unresectable, advanced or recurrent colorectal cancer(Part D)<br><br> - Life expectancy of at least 3 months<br><br> - Patients with ECOG performance status 0 or 1<br><br>Exclusion Criteria:<br><br> - Patients with severe complication<br><br> - Patients with multiple primary cancers
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluation of the safety (adverse event, clinical laboratory test, 12-lead electrocardiography, chest X-ray, ECOG performance status)
- Secondary Outcome Measures
Name Time Method Maximum observed serum concentration(Cmax);Area Under the blood concentration-time Curve(AUC);Half-life(T1/2) of ONO-4578 both alone and in combination with ONO-4538