drugset / Trial / NCT03866239

A Phase Ib Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Cibisatamab in Combination With Atezolizumab After Pretreatment With Obinutuzumab in Participants With Previously Treated Metastatic Colorectal Adenocarcinoma

NCT03866239

Phase 1 Terminated 47 enrolled Hoffmann-La Roche
NaSingle-groupOpen-labelTreatment

Summary

CO40939 is a Phase Ib, open-label, multicenter, single-arm study designed to evaluate the safety, efficacy, pharmacokinetics, and immunogenicity of cibisatamab in combination with atezolizumab administered after pretreatment with obinutuzumab in patients with Stage IV microsatellite stable (MSS) metastatic colorectal cancer (mCRC) whose tumors have high carcinoembryonic antigen-related cell adhesion molecule 5 (CEACAM5) expression and who have progressed on two or more chemotherapy regimens. The study is composed of a safety run-in and an exploratory part.

Timeline

Start
2019-05-07
Primary completion
2024-03-13
Completion
2024-03-13

Drugs

EvaluationDrugModalityDoseRoute
Subject Atezolizumab Monoclonal antibody 1200 mg Intravenous
Subject Cibisatamab Monoclonal antibody 100 mg Intravenous
Background Obinutuzumab Monoclonal antibody Intravenous
Background Tocilizumab Monoclonal antibody Intravenous

Indications