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

Purpose

Study 849-010 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

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts 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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
MRTX849 + Cetuximab
  • Drug: MRTX849
    28 Day Cycle
  • Biological: Cetuximab
    28 Day Cycle
    Other names:
    • Erbitux
Active Comparator
mFOLFOX6 or FOLFIRI
  • Drug: mFOLFOX6 Regimen
    Fluorouracil Oxaliplatin Folinic acid
  • Drug: FOLFIRI Regimen
    Fluorouracil Irinotecan Folinic acid

More Details

Status
Active, not recruiting
Sponsor
Mirati Therapeutics Inc.

Study Contact