Phase 3 Study of MRTX849 With Cetuximab vs Chemotherapy in Patients With Advanced Colorectal Cancer With KRAS G12C Mutation (KRYSTAL-10)
About
Brief Summary
Study 849-010 is an open-label, randomized Phase 3 clinical trial comparing the efficacy of MRTX849 administered in combination with cetuximab versus chemotherapy in the second-line treatment setting in patients with CRC with KRAS G12C mutation.
Primary Purpose
Study Type
Phase
Eligibility
Gender
Healthy Volunteers
Minimum Age
Maximum Age
Inclusion Criteria:
- Histologically confirmed diagnosis of colorectal carcinoma with KRAS G12C mutation in tumor tissue.
- Prior receipt of 1st line treatment in advanced CRC with a fluoropyrimidine-based chemotherapy regimen containing either oxaliplatin or irinotecan, and radiographically documented progression of disease on or after treatment.
Exclusion Criteria:
- Prior treatment with a therapy targeting KRAS G12C mutation (e.g., AMG 510).
- Prior treatment with an anti-EGFR antibody (e.g., cetuximab or panitumumab).
- Active brain metastasis
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Study Stats
Protocol No.
23-000317
Category
Colorectal Cancer
Principal Investigator
Randolph Hecht
Contact
Location
- TRIO-US - Bakersfield
- TRIO-US - Redondo Beach
- TRIO-US - Sylmar
- TRIO-US - Whittier