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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
47
Obinutuzumab will be administered by intravenous (IV) infusion as either a split or single dose approximately 2 weeks before Cycle 1, Day 1 (cycle = 21 days).
Atezolizumab will be administered at a fixed dose of 1200 mg by IV infusion on Day 1 of each 21-day cycle until radiographic progression, unacceptable toxicity, or loss of clinical benefit.
Cibisatamab will be administered at a fixed dose of 100 mg by IV infusion on Day 1 of each 21-day cycle until radiographic progression, unacceptable toxicity, or loss of clinical benefit.
Tocilizumab will be administered by IV infusion as necessary to manage adverse events (AEs)
Cedars Sinai Medical Center
Los Angeles, California, United States
UCLA Cancer Center
Santa Monica, California, United States
Stanford Comprehensive Cancer Center
Stanford, California, United States
Yale University
New Haven, Connecticut, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Duke Cancer Center
Durham, North Carolina, United States
MD Anderson Cancer Center
Houston, Texas, United States
Rigshospitalet; Fase 1 Enhed - Onkologi
København Ø, Denmark
Centre Leon Berard; Departement Oncologie Medicale
Lyon, France
Institut Gustave Roussy
Villejuif, France
...and 3 more locations
Percentage of Participants with Adverse Events (AEs)
Time frame: Up to 5 years
Confirmed Objective Response Rate (ORR)
Time frame: Baseline up to 5 years
Confirmed ORR, as Determined by an Independent Review Facility (IRF) According to Response Evaluation in Solid Tumors version 1.1 (RECIST v1.1)
Time frame: Up to 5 years
Duration of Response (DOR)
Time frame: From the first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first (up to 5 years)
Disease Control Rate (DCR)
Time frame: Up to 5 years
Progression Free Survival (PFS)
Time frame: From enrollment to the first occurrence of disease progression or death from any cause, whichever occurs first (up to 5 years)
Overall Survival (OS)
Time frame: From enrollment to death from any cause (up to 5 years)
Total Clearance (CL) for Cibisatamab
Time frame: At pre-defined intervals from Day 1 to progressive disease and/or treatment discontinuation (up to 5 years)
Volume of Distribution at Steady State (Vss) of Cibisatamab
Time frame: At pre-defined intervals from Day 1 to progressive disease and/or treatment discontinuation (up to 5 years)
Area Under the Concentration-Time Curve (AUC0-t) for Cibisatamab
Time frame: At pre-defined intervals from Day 1 to progressive disease and/or treatment discontinuation (up to 5 years)
Maximum Serum Concentration (Cmax) of Cibisatamab
Time frame: At pre-defined intervals from Day 1 to progressive disease and/or treatment discontinuation (up to 5 years)
CL of Atezolizumab
Time frame: At pre-defined intervals from Day 1, Cycle 1 through Cycle 8 (cycle = 21 days)
Vss of Atezolizumab
Time frame: At pre-defined intervals from Day 1, Cycle 1 through Cycle 8 (cycle = 21 days)
AUC0-t of Atezolizumab
Time frame: At pre-defined intervals from Day 1, Cycle 1 through Cycle 8 (cycle = 21 days)
Cmax of Atezolizumab
Time frame: At pre-defined intervals from Day 1, Cycle 1 through Cycle 8 (cycle = 21 days)
CL of Obinutuzumab
Time frame: At pre-defined intervals from the start of obinutuzumab pretreatment through Cycle 8 (cycle = 21 days)
Vss of Obinutuzumab
Time frame: At pre-defined intervals from the start of obinutuzumab pretreatment through Cycle 8 (cycle = 21 days)
AUC0-t of Obinutuzumab
Time frame: At pre-defined intervals from the start of obinutuzumab pretreatment through Cycle 8 (cycle = 21 days)
Cmax of Obinutuzumab
Time frame: At pre-defined intervals from the start of obinutuzumab pretreatment through Cycle 8 (cycle = 21 days)
Incidence of Anti-Drug Antibodies (ADAs) to Cibisatamab
Time frame: Baseline up to 5 years
Incidence of ADAs to Atezolizumab
Time frame: Baseline up to 5 years
Incidence of ADAs to Obinutuzumab
Time frame: Baseline up to 5 years
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