NCT06412198 A Multicenter Phase 1b/2 Study of Adagrasib, Cetuximab, and Cemiplimab for Metastatic Colorectal Cancer Harboring KRAS G12C Mutations
| NCT ID | NCT06412198 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | M.D. Anderson Cancer Center |
| Condition | Metastatic Colorectal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 31 participants |
| Start Date | 2024-08-28 |
| Primary Completion | 2029-03-01 |
Trial Parameters
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Brief Summary
To learn if the drug combination of adagrasib, cetuximab, and cemiplimab can help to control metastatic CRC with KRAS G12C mutations.
Eligibility Criteria
Inclusion Criteria: * Histologically confirmed diagnosis of advanced/metastatic microsatellite stable colorectal cancer with KRASG12C mutation with 1+ prior line(s) of therapy * Confirmed KRASG12C mutation status. If a molecular profiling report is not available, a representative paraffin-embedded tumor block or a minimum of 10 unstained slides will be requested for retrospective KRASG12C mutation testing. * Unresectable or metastatic disease. * Participants must have received at least one prior line of chemotherapy for metastatic disease with progression on treatment or intolerance to therapy. * Presence of measurable disease per RECIST 1.1 * Willingness to participate in on-study related procedures, including mandatory biopsies (one baseline and one on-treatment biopsy). * Age ≥ 18 years. Because no dosing or adverse event data are currently available on the use of the proposed combination in patients \<18 years of age, children are excluded from this study. * Able to take oral medic
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