Phase 3 Study of MRTX849 With Cetuximab vs Chemotherapy in Patients With Advanced Colorectal Cancer With KRAS G12C Mutation (KRYSTAL-10)

• Status: Recruiting
• Trial end date: 2024-12-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mirati Therapeutics Inc.
• Treatments: Adagrasib; Cetuximab

Criteria

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