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Clinical Trials in South Korea / NCT04793958
Active, not recruiting Phase 3

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 South Korea tracker
Sponsor
Mirati Therapeutics Inc
Phase
Phase 3
Started
2021-06-24
Last updated
2026-09-28

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
No
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)

FacilityCityRegionStatus
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 South Korea

A Solid Tumor Study for Long Term Treatment of Cancer Patients Who Participated in Adagrasib Studies Recruiting
Trial of Two Adagrasib Dosing Regimens in NSCLC With KRAS G12C Mutation (KRYSTAL 21) Active, not recruiting
Phase 3 Study of MRTX849 (Adagrasib) vs Docetaxel in Patients With Advanced Non-Small Cell Lung Cancer With KRAS G12C Mutation Active, not 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
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

Other trials for the same condition

A Study of Novel Study Interventions and Combinations in Participants With Colorectal Cancer Recruiting
A Study Evaluating the Safety and Efficacy of Targeted Therapies in Subpopulations of Patients With Metastatic Colorectal Cancer (INTRINSIC) Recruiting
Study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb in Treatment-naïve Participants With Metastatic Colorectal Cancer With KRAS p.G12C Mutation Recruiting
A Study Assessing Adverse Events and Disease Activity of Intravenously (IV) Infused Telisotuzumab Adizutecan in Adult Participants With c-Met Protein Above Cutoff Level Above Refractory Metastatic Colorectal Cancer Active, not recruiting
A Study to Evaluate Safety and Efficacy of BEY1107 in Combination with Capecitabine in Patients with Metastatic Colorectal Cancer 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 South Korea