A Randomized Phase 3 Study of MRTX849 in Combination with Cetuximab Versus Chemotherapy in Patients with Advanced Colorectal Cancer with KRAS G12C Mutation with Disease Progression On or After Standard First-Line Therapy

Protocol No
MIRATI-849-010-KRYSTAL-10
Phase
III
Summary

This study will compare the effectiveness of MRTX849 in combination with Cetuximab
(investigational arm) versus standard of care second-line treatment consisting of either FOLFIRI
or mFOLFOX6 chemotherapy (comparator arm) in patients with advanced colorectal cancer
who have a specific change in tumor genes (KRAS G12C) and who are experiencing
progression on or after first-line chemotherapy. Chemotherapy is a treatment that includes a
medication or combination of medications that work throughout the body to help fight cancer.

Other objectives of the study include evaluating the safety of MRTX849 in combination with
Cetuximab, assessing how quickly MRTX849 is absorbed into the blood stream and how fast it
is removed, and evaluating your health-related quality of life. Several laboratory tests will be
performed using samples of tumor tissue or blood to understand how and why MRTX849 with
Cetuximab may work in the treatment of colorectal cancer.

Description
Phase 3 Study of MRTX849 with Cetuximab vs Chemotherapy in Patients with Advanced Colorectal Cancer with KRAS G12C Mutation (KRYSTAL-10)
Participating Institutions
Froedtert Hospital
Status
OPEN TO ACCRUAL