NCT04793958

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

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 461 (actual)
• Sponsor: Mirati Therapeutics Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Colorectal Cancer
• Metastatic Colorectal Cancer

Interventions

Type	Name	Description
DRUG	MRTX849	28 Day Cycle
BIOLOGICAL	Cetuximab	28 Day Cycle
DRUG	mFOLFOX6 Regimen	* Fluorouracil * Oxaliplatin * Folinic acid
DRUG	FOLFIRI Regimen	* Fluorouracil * Irinotecan * Folinic acid

Timeline

• Start date: 2021-06-24
• Primary completion: 2026-01-30
• Completion: 2026-01-30
• First posted: 2021-03-11
• Last updated: 2025-02-11

Locations

419 sites across 32 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Colombia, Czechia, Denmark, Finland, France, Germany, Greece, Hong Kong, Ireland, Italy, Malaysia, Mexico, Netherlands, Poland, Portugal, Puerto Rico, Romania, Singapore, South Korea, Spain, Taiwan, Thailand, Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study