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 Canada 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)

MRTX849 →Cetuximab →mFOLFOX6 Regimen →FOLFIRI 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.

More Mirati Therapeutics Inc. trials in Canada

A Solid Tumor Study for Long Term Treatment of Cancer Patients Who Participated in Adagrasib Studies Recruiting

A Study of Adagrasib Plus Pembrolizumab Plus Chemotherapy vs. Placebo Plus Pembrolizumab Plus Chemotherapy in Participants With Previously Untreated Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation (KRYSTAL-4) Recruiting

Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination in Patients With a KRAS G12C Mutation KRYSTAL-7 Recruiting

Other trials for the same condition

A Study of Precemtabart Tocentecan With or Without Bevacizumab Compared to Trifluridine/Tipiracil Plus Bevacizumab in Participants With Previously Treated Metastatic Colorectal Cancer (PROCEADE-CRC-03) Recruiting

Study of Hydroxychloroquine With FOLFIRI and Bevacizumab in DTP-high Metastatic Colorectal Cancer Active, not recruiting

A Study of Encorafenib Plus Cetuximab Taken Together With Pembrolizumab Compared to Pembrolizumab Alone in People With Previously Untreated Metastatic Colorectal Cancer Active, not recruiting

A Study Evaluating the Safety and Efficacy of Targeted Therapies in Subpopulations of Patients With Metastatic Colorectal Cancer (INTRINSIC) Recruiting

Sotevtamab (AB-16B5) Combined With FOLFOX as Neoadjuvant Treatment Prior to Resection of Colorectal Cancer Liver Metastasis Recruiting

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 Canada