Study of ONO-4578 With and Without ONO-4538 in Subjects Advanced or Metastatic Solid Tumors
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
Sponsor: Ono Pharmaceutical Co., Ltd.
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Evaluation of the safety (adverse event, clinical laboratory test, 12-lead electrocardiography, chest X-ray, ECOG performance status)
Time frame: Through study completion, an average of 1 year
Secondary Endpoints
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
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
✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
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