Actively Recruiting
Study of Adagrasib, Cetuximab, and Cemiplimab Combination for Metastatic Colorectal Cancer with KRAS G12C Mutations
Led by M.D. Anderson Cancer Center · Updated on 2026-03-06
31
Participants Needed
2
Research Sites
235 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the combination of three drugs—adagrasib, cetuximab, and cemiplimab—for treating metastatic colorectal cancer with KRAS G12C mutations that has worsened after at least one prior chemotherapy treatment. This phase 1b/2 study aims to determine the response rate to this combination and assess how long the response lasts, progression-free survival, overall survival, and safety. The study also explores biomarkers, tumor adaptation, resistance mechanisms, and effects on the tumor immune environment. Participants receive adagrasib orally, while cetuximab and cemiplimab are given intravenously. The treatment involves administering all three drugs together, with the study including participants who have measurable disease and have progressed on prior therapies. The study includes mandatory biopsies before and during treatment to understand tumor biology and response to therapy. Throughout the study, participants will be closely monitored for safety and any adverse events for about one year. Researchers will conduct various tests and assessments, including biopsies and laboratory evaluations, to measure treatment effects and side effects. Participants must be willing to comply with study procedures and contraception requirements if applicable, and their health status will be regularly evaluated to ensure safety and treatment tolerability.
CONDITIONS
Official 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
- Disease that is unresectable or metastatic
- Received at least one prior line of chemotherapy for metastatic disease with progression or intolerance
- Presence of measurable disease according to RECIST 1.1
- Willing to participate in study procedures, including mandatory biopsies
- Age 18 years or older
- Able to take oral medications
- Prior systemic therapy and radiation therapy stopped at least 7 days before first dose
- Recovery from prior treatment side effects to Grade 1 or less (excluding alopecia and oxaliplatin-induced neuropathy)
- ECOG performance status of 0 or 1
- Laboratory values within specified limits including neutrophil count, platelet count, hemoglobin, bilirubin, liver enzymes, and creatinine clearance
- Signed informed consent form
- Willing and able to comply with study requirements
- Participants able to have children and sexually active must agree to use effective contraception during treatment and for 6 months after last dose
- Women considered not of childbearing potential if post-menopausal for 12 months or had surgical sterilization at least 6 months ago
You will not qualify if you...
- Prior treatment with PD1 or CTLA4 inhibitors
- Prior KRAS G12C inhibitor therapy
- Immunodeficiency or systemic steroid/immunosuppressive therapy within 7 days before first dose
- Active autoimmune disease requiring systemic treatment in past 2 years (except replacement therapy)
- Active brain metastases unless treated and neurologically stable for at least 2 weeks without corticosteroids or on low stable dose
- Need for medications with known drug interactions that cannot be switched within 10 days before study entry
- Major surgery within 4 weeks before first dose
- 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 (with some exceptions for treated or inactive carriers)
- Any serious or uncontrolled illness or infection that may interfere with participation or result interpretation
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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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