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

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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)

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

Trial contacts and locations

394

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Central trial contact

Mirati Therapeutics Study Locator Services

Data sourced from clinicaltrials.gov

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