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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Hoffmann-La Roche
Study ID
NCT03866239
Phase
PHASE1
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Obinutuzumab — DRUG
    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 — DRUG
    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 — DRUG
    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 — DRUG
    Tocilizumab will be administered by IV infusion as necessary to manage adverse events (AEs)

Study Details

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.

Key Dates

Start date
May 7, 2019
Status verified
Aug 2024
Primary completion
Mar 13, 2024
Completion
Mar 13, 2024

Study Design

Enrollment
47 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Obinutuzumab Pretreatment (OpT) + Cibisatamab + Atezolizumab
    Participants will receive obinutuzumab approximately 2 weeks before receiving atezolizumab and cibisatamab on Day 1 of each treatment cycle (cycle = 21 days).

Primary Outcome Measure

Percentage of Participants with Adverse Events (AEs) [ Time Frame: Up to 5 years ]

Locations (7)

FacilityCityStateZIPSite coordinators
Cedars Sinai Medical CenterLos AngelesCalifornia90048-
UCLA Cancer CenterSanta MonicaCalifornia90404-
Stanford Comprehensive Cancer CenterStanfordCalifornia94305-
Yale UniversityNew HavenConnecticut06510-
Memorial Sloan-Kettering Cancer CenterNew YorkNew York10065-
Duke Cancer CenterDurhamNorth Carolina27710-
MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Los Angeles, CA

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
Cedars Sinai Medical Center· Los Angeles, CAUCLA Cancer Center· Santa Monica, CAStanford Comprehensive Cancer Center· Stanford, CAYale University· New Haven, CTMemorial Sloan-Kettering Cancer Center· New York, NYDuke Cancer Center· Durham, NC

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