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NCT Number: NCT04793958

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Advanced Colorectal Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Metastatic Colorectal Cancer Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Local Institution - 010-431, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MRTX849

Drug

28 Day Cycle

Cetuximab

Biological

28 Day Cycle

Other names: Erbitux

mFOLFOX6 regimen

Drug
  • Fluorouracil
  • Oxaliplatin
  • Folinic acid

FOLFIRI regimen

Drug
  • Fluorouracil
  • Irinotecan
  • Folinic acid

Primary outcomes

  1. Overall Survival (OS)

    Time frame: 30 months

    Defined as time from date of randomization to date of death due to any cause.

  2. Progression-free Survival (PFS)

    Time frame: 30 months

    Defined as time from randomization until disease progression or death from any cause, whichever occurs first.

Secondary outcomes

  1. Adverse Events

    Time frame: 30 months

    Defined as number of patients with treatment emergent AEs.

  2. Objective Response Rate (ORR)

    Time frame: 30 months

    Defined as the percent of patients documented to have a confirmed CR or PR.

  3. Duration of Response (DOR)

    Time frame: 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.

  4. Patient Reported Outcomes (PROs)

    Time frame: 30 months

    To be assessed by European Quality of Life Questionnaire for Cancer Patients (QLQ-C30).

  5. Quality of Life Assessment

    Time frame: 30 months

    To be assessed by European Quality of Life Five Dimensions Questionnaire (EQ-5D-5L).

Sponsors and collaborators

Lead sponsor

Mirati Therapeutics Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Mar 11, 2021
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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