Actively Recruiting
A Multicenter Phase 1b/2 Study of Adagrasib, Cetuximab, and Cemiplimab for Metastatic Colorectal Cancer Harboring KRAS G12C Mutations
Led by M.D. Anderson Cancer Center · Updated on 2026-03-06
31
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying whether the combination of three drugs—adagrasib, cetuximab, and cemiplimab—can help control metastatic colorectal cancer that has a specific KRAS G12C mutation and has progressed after at least one prior chemotherapy treatment. This multicenter trial includes participants with advanced disease who have measurable tumors and have met certain health criteria. The study is a Phase 1b/2 trial aiming to find the response rate, safety, and other outcomes of this drug combination. Participants will receive adagrasib orally, with the dose determined during a Lead-In phase where two different doses are tested for tolerability. Following this, in the Expansion phase, participants will receive the recommended dose of adagrasib. Cetuximab and cemiplimab are given intravenously alongside adagrasib. The study involves treatment cycles and includes mandatory biopsies to understand how the drugs affect the tumor and immune environment. During the trial, participants will undergo safety monitoring for adverse effects over about a year. Researchers will assess tumor response, progression, and overall survival. Blood tests, scans, and biopsies will be performed to monitor health and study drug effects. Participants must be willing to comply with study procedures and contraception requirements. The study is led by M.D. Anderson Cancer Center and will last until March 2029.
CONDITIONS
Brief Title
A Multicenter Phase 1b/2 Study of Adagrasib, Cetuximab, and Cemiplimab for Metastatic Colorectal Cancer Harboring KRAS G12C Mutations
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed advanced or metastatic microsatellite stable colorectal cancer with KRAS G12C mutation
- At least one prior line of therapy for metastatic disease
- Confirmed KRAS G12C mutation status
- Unresectable or metastatic disease
- Measurable disease per RECIST 1.1
- Age 18 years or older
- Able to take oral medications
- Most recent systemic or radiation therapy stopped at least 7 days before study drug
- Recovery from prior treatment side effects to Grade 1 or less (except alopecia and prior oxaliplatin neuropathy)
- ECOG performance status of 0 or 1
- Laboratory values within specified limits for blood counts, liver and kidney function
- Willingness to participate in study procedures including biopsies
- Signed informed consent
- Ability to comply with study instructions
- Use of effective contraception during treatment and for 6 months after
- Women considered not of childbearing potential must meet specific criteria
You will not qualify if you...
- Prior PD1 or CTLA4 inhibitor therapy
- Prior KRAS G12C inhibitor therapy
- Immunodeficiency or systemic steroid or immunosuppressive therapy within 7 days before dosing
- Active autoimmune disease requiring systemic treatment in past 2 years
- Active brain metastases unless treated and stable without corticosteroids or on low stable dose
- Use of medications with certain drug interaction risks that cannot be switched
- Major surgery within 4 weeks before dosing
- History of intestinal disease or major gastric surgery affecting drug absorption
- Pregnancy or breastfeeding
- Symptomatic leptomeningeal disease
- Known HIV infection or active hepatitis B or C infection, with some exceptions
- Serious or uncontrolled illness or psychiatric condition that may interfere with participation or results
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to approximately 1 year or until disease progression or unacceptable side effects.
Participants receive the combination of adagrasib, cetuximab, and cemiplimab to treat advanced KRAS G12C mutated metastatic colorectal cancer.
Regular visits for IV and oral medication administration, including monitoring for safety and response.
Trial Site Locations
Total: 2 locations
1
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114
Not Yet Recruiting
2
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
C
Christine Parseghian, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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