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

Trial Status: Active

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.

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

Colorado

Aurora
University of Colorado Hospital
Status: APPROVED

Georgia

Atlanta
Emory University Hospital / Winship Cancer Institute
Status: IN_REVIEW

Iowa

Iowa City
University of Iowa / Holden Comprehensive Cancer Center
Status: IN_REVIEW

New Jersey

New Brunswick
Rutgers Cancer Institute of New Jersey
Status: APPROVED
Contact: Olga A Kovalenko
Phone: 732-235-4024

Ohio

Cleveland
Case Comprehensive Cancer Center
Status: IN_REVIEW

Texas

Houston
M D Anderson Cancer Center
Status: ACTIVE

Trial Phase Phase III

Trial Type Treatment

Lead Organization
Mirati Therapeutics

  • Primary ID 849-010
  • Secondary IDs NCI-2021-03009, KRYSTAL-10
  • Clinicaltrials.gov ID NCT04793958