RecruitingPhase 1Phase 2NCT06412198
A Multicenter Phase 1b/2 Study of Adagrasib, Cetuximab, and Cemiplimab for Metastatic Colorectal Cancer Harboring KRAS G12C Mutations
Sponsor
M.D. Anderson Cancer Center
Enrollment
31 participants
Start Date
Aug 28, 2024
Study Type
INTERVENTIONAL
Conditions
Summary
To learn if the drug combination of adagrasib, cetuximab, and cemiplimab can help to control metastatic CRC with KRAS G12C mutations.
Eligibility
Min Age: 18 Years
Plain Language Summary
Simplified for easier understanding
This study tests a three-drug combination — adagrasib (a KRAS G12C inhibitor), cetuximab (a targeted antibody), and cemiplimab (an immunotherapy) — in patients with advanced colorectal cancer that has a specific KRAS G12C gene mutation. KRAS G12C mutations are found in roughly 3–4% of colorectal cancers and are difficult to treat.
**You may be eligible if...**
- You are 18 or older with metastatic or unresectable colorectal cancer
- Your tumor has a confirmed KRAS G12C mutation
- Your cancer is microsatellite stable
- You have received at least one prior line of chemotherapy for metastatic disease
- You have measurable disease and are willing to undergo tumor biopsies
**You may NOT be eligible if...**
- Your tumor does not have a KRAS G12C mutation
- You have not yet tried chemotherapy for metastatic disease
- You are unwilling to undergo mandatory tumor biopsies
Talk to your doctor to see if this trial is right for you.
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
DRUGCetuximab
Given by IV
DRUGCemiplimab
Given by IV
DRUGAdagrasib
Given by PO
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06412198
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