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

NCT04793958 · tracked via the Priya Life Science Ireland tracker

Sponsor

Mirati Therapeutics Inc.

Phase

Phase 3

Started

2021-06-24

Last updated

2026-07-23

Condition(s) studied

Advanced Colorectal CancerMetastatic Colorectal Cancer

Investigational drug(s) / intervention(s)

MRTX849CetuximabmFOLFOX6 RegimenFOLFIRI Regimen

MRTX849: 28 Day Cycle

Cetuximab: 28 Day Cycle

mFOLFOX6 Regimen: * Fluorouracil * Oxaliplatin * Folinic acid

FOLFIRI Regimen: * Fluorouracil * Irinotecan * Folinic acid

Study summary

Study CA239-0006 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Overall Survival (OS) — 30 months
Defined as time from date of randomization to date of death due to any cause.
Progression-free Survival (PFS) — 30 months
Defined as time from randomization until disease progression or death from any cause, whichever occurs first.

Trial sites (419)

Facility	City	Region
Local Institution - 010-855-E	Alabaster	Alabama
Local Institution - 010-855-B	Bessemer	Alabama
Local Institution - 010-855-D	Birmingham	Alabama
Local Institution - 010-855-A	Birmingham	Alabama
Local Institution - 010-855-F	Birmingham	Alabama
Local Institution - 010-855-C	Birmingham	Alabama
Local Institution - 010-855	Birmingham	Alabama
Local Institution - 010-996	Gilbert	Arizona
Local Institution - 010-566	Goodyear	Arizona
Local Institution - 010-989	Phoenix	Arizona
Local Institution - 010-978	Springdale	Arkansas
Local Institution - 010-573	Bakersfield	California
Local Institution - 010-979C	Chula Vista	California
Local Institution - 010-980	Fresno	California
Local Institution - 010-851	Fullerton	California
Local Institution - 010-979A	La Mesa	California
Local Institution - 010-958A	Los Angeles	California
Local Institution - 010-958	Los Angeles	California
Local Institution - 010-551	Los Angeles	California
Local Institution - 010-847	Newport Beach	California
Local Institution - 010-563	Redlands	California
Local Institution - 010-979B	San Diego	California
Local Institution - 010-979D	San Diego	California
Local Institution - 010-979	San Diego	California
Local Institution - 010-982	San Francisco	California
Local Institution - 010-561	Santa Monica	California
Local Institution - 010-571	Sylmar	California
Local Institution - 010-574	Torrance	California
Local Institution - 010-570	Whittier	California
Local Institution - 010-872-H	Aurora	Colorado
Local Institution - 010-810	Aurora	Colorado
Local Institution - 010-872-A	Boulder	Colorado
Local Institution - 010-872-E	Centennial	Colorado
Local Institution - 010-872-C	Colorado Springs	Colorado
Local Institution - 010-872	Denver	Colorado
Local Institution - 010-872-B	Denver	Colorado
Local Institution - 010-872-J	Lakewood	Colorado
Local Institution - 010-872-F	Littleton	Colorado
Local Institution - 010-872-G	Longmont	Colorado
Local Institution - 010-872-I	Pueblo	Colorado

+ 379 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04793958 on ClinicalTrials.gov ↗ ← All trials in Ireland