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Active Not Recruiting NCT03155061

Study of ONO-4578 With and Without ONO-4538 in Subjects Advanced or Metastatic Solid Tumors

Conditions: Advanced or Metastatic Solid Tumors

Sex: All

Ages: 20 Years – N/A

Healthy volunteers: No

Phase: PHASE1

Enrollment: 183

Sponsor: Ono Pharmaceutical Co., Ltd.

Location: Aichi Clinical Site 1 Nagoya Aichi-ken

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 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

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT03155061). StuddyBuddy aggregates publicly available trial information.