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

Mirati Therapeutics

Status and phase: Active, not recruiting; Phase 3

Conditions: Metastatic Colorectal Cancer; Advanced Colorectal Cancer

Treatments: Drug: MRTX849; Biological: Cetuximab; Drug: FOLFIRI Regimen; Drug: mFOLFOX6 Regimen

Study type: Interventional

Funder types: Industry

Identifiers

NCT04793958

849-010

CA239-0006

KRYSTAL-10 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 461 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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461 participants in 2 patient groups

MRTX849 + Cetuximab

Experimental group

Treatment:

Biological: Cetuximab

Drug: MRTX849

mFOLFOX6 or FOLFIRI

Active Comparator group

Treatment:

Drug: mFOLFOX6 Regimen

Drug: FOLFIRI Regimen