Phase 3 Study of MRTX849 With Cetuximab vs Chemotherapy in Patients With Advanced Colorectal Cancer With KRAS G12C Mutation (KRYSTAL-10)
Purpose
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.
Conditions
- Advanced Colorectal Cancer
- Metastatic Colorectal Cancer
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental MRTX849 + Cetuximab |
|
|
Active Comparator mFOLFOX6 or FOLFIRI |
|
More Details
- Status
- Active, not recruiting
- Sponsor
- Mirati Therapeutics Inc.