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
235 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To learn if the drug combination of adagrasib, cetuximab, and cemiplimab can help to control metastatic CRC with KRAS G12C mutations.
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
AI-Screening
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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
CONTACT
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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