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

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04793958

Enrollment

461

Registered

2021-03-11

Start date

2021-06-24

Completion date

2026-01-30

Last updated

2025-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Colorectal Cancer, Metastatic Colorectal Cancer

Keywords

Colorectal Cancer, Colorectal Cancer Trial, Colorectal Carcinoma, Rectal Cancer, Colon Cancer, KRAS, KRAS G12C, RAS, Colorectal Adenocarcinoma

Brief 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.

Interventions

DRUGMRTX849

28 Day Cycle

BIOLOGICALCetuximab

28 Day Cycle

DRUGmFOLFOX6 Regimen

* Fluorouracil * Oxaliplatin * Folinic acid

DRUGFOLFIRI Regimen

* Fluorouracil * Irinotecan * Folinic acid

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Secondary

Measure	Time frame	Description
Duration of Response (DOR)	30 months	Defined as the time from date of the first documentation of objective tumor response (CR or PR) to the first documentation of either Progression of Disease (PD) or death due to any cause, whichever occurs first.
Adverse Events	30 months	Defined as number of patients with treatment emergent AEs.
Quality of Life Assessment	30 months	To be assessed by European Quality of Life Five Dimensions Questionnaire (EQ-5D-5L).
Patient Reported Outcomes (PROs)	30 months	To be assessed by European Quality of Life Questionnaire for Cancer Patients (QLQ-C30).
Objective Response Rate (ORR)	30 months	Defined as the percent of patients documented to have a confirmed CR or PR.

Countries

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, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026