A Phase 1/2 Multiple Expansion Cohort Trial of MRTX849 in Patients With Advanced Solid Tumors With KRAS G12C Mutation

Last updated: N/A
Sponsor: N/A
Overall Status: Active - Recruiting

Phase

1/2

Condition

Colon Cancer

Metastatic Cancer

Solid Tumors

Treatment

N/A

Clinical Study ID

TX223046
  • Ages 18-99
  • All Genders

Study Summary

Evaluates the safety, tolerability, pharmacokinetics, metabolites, pharmacodynamics, and clinical activity of MRTX849 in patients with advanced solid tumors with a KRAS G12C mutation. MRTX849 is an orally-available small molecule inhibitor of KRAS G12C.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Histologically confirmed diagnosis of a solid tumor malignancy with KRAS G12C mutation

  • Unresectable or metastatic disease

  • Standard treatment is not available or patient declines

  • Adequate organ function

Exclusion

Exclusion Criteria:**

  • Active brain metastases
  • History of intestinal disease or major gastric surgery or inability to swallow oral medications
  • Other active cancer

Study Design

Study Start date:
Estimated Completion Date:

Study Description

  • Phase 1 dose escalation of MRTX849 to determine maximum tolerated dose.
  • Phase 1b expansion cohort to ensure sufficient safety experience, pharmacokinetic information, and early evidence of clinical activity of MRTX849 to recommend Phase 2 regimens.
  • Separate Phase 2 cohorts of patients stratified by histological diagnosis for evaluation of clinical activity of MRTX849.
  • MRTX849 will be administered orally in a continuous regimen.

The Pilot Phase 1b Combination with Pembrolizumab arm of the study will evaluate the safety, tolerability, PK, and clinical activity of the investigational study agent, MRTX849, in combination with pembrolizumab in patients with NSCLC. The Pilot Phase 1b Combination with Cetuximab arm of the study will evaluate the safety, tolerability, PK, and clinical activity of MRTX849 in combination with cetuximab in patients with CRC. Lastly, the Pilot Phase 1b Combination with Afatinib arm of the study will evaluate the safety, tolerability, PK and clinical activity of MRTX849 in combination with afatinib in patients with NSCLC.

Connect with a study center

  • Mirati Research Site

    San Juan, San Juan 00935
    Puerto Rico

    Active - Recruiting

  • Mirati Research Site

    Birmingham, Alabama 35294
    United States

    Active - Recruiting

  • Mirati Research Site

    Phoenix, Arizona 85054
    United States

    Active - Recruiting

  • Mirati Research Site

    Tucson, Arizona 85704
    United States

    Active - Recruiting

  • Mirati Research Site

    Bellflower, California 90706
    United States

    Active - Recruiting

  • Mirati Research Site

    Beverly Hills, California 90211
    United States

    Active - Recruiting

  • Mirati Research Site

    Duarte, California 91010
    United States

    Active - Recruiting

  • Mirati Research Site

    La Jolla, California 92093
    United States

    Active - Recruiting

  • Mirati Research Site

    Newport Beach, California 92663
    United States

    Active - Recruiting

  • Mirati Research Site

    Orange, California 92868
    United States

    Active - Recruiting

  • Mirati Research Site

    San Diego, California 92111
    United States

    Active - Recruiting

  • Mirati Research Site

    Santa Barbara, California 93105
    United States

    Active - Recruiting

  • Mirati Research Site

    Aurora, Colorado 80012
    United States

    Active - Recruiting

  • Mirati Research Site

    Aurora, Colorado 80045
    United States

    Active - Recruiting

  • Mirati Research Site

    Grand Junction, Colorado 81501
    United States

    Active - Recruiting

  • Mirati Research Site

    New Haven, Connecticut 06511
    United States

    Active - Recruiting

  • Mirati Research Site

    Newark, Delaware 19713
    United States

    Active - Recruiting

  • Mirati Research Site

    Jacksonville, Florida 32224
    United States

    Active - Recruiting

  • Mirati Research Site

    Miami, Florida 33176
    United States

    Active - Recruiting

  • Mirati Research Site

    Miami Beach, Florida 33140
    United States

    Active - Recruiting

  • Mirati Research Site

    Pensacola, Florida 32503
    United States

    Active - Recruiting

  • Mirati Research Site

    Plantation, Florida 33322
    United States

    Active - Recruiting

  • Mirati Research Site

    Marietta, Georgia 30060
    United States

    Active - Recruiting

  • Mirati Research Site

    Niles, Illinois 60714
    United States

    Active - Recruiting

  • Mirati Research Site

    Iowa City, Iowa 52242
    United States

    Active - Recruiting

  • Mirati Research Site

    Westwood, Kansas 66205
    United States

    Active - Recruiting

  • Mirati Research Site

    Lexington, Kentucky 40536
    United States

    Active - Recruiting

  • Mirati Research Site

    Biddeford, Maine 04005
    United States

    Active - Recruiting

  • Mirati Research Site

    Columbia, Maryland 21044
    United States

    Active - Recruiting

  • Mirati Research Site

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

  • Mirati Research Site

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • Mirati Research Site

    Detroit, Michigan 48377
    United States

    Active - Recruiting

  • Mirati Research Site

    Minneapolis, Minnesota 55404
    United States

    Active - Recruiting

  • Mirati Research Site

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

  • Mirati Research Site

    St. Louis Park, Minnesota 55416
    United States

    Active - Recruiting

  • Mirati Research Site

    Jefferson City, Missouri 65109
    United States

    Active - Recruiting

  • Mirati Research Site

    Billings, Montana 59102
    United States

    Active - Recruiting

  • Mirati Research Site

    Omaha, Nebraska 68130
    United States

    Active - Recruiting

  • Mirati Research Site

    Buffalo, New York 14203
    United States

    Active - Recruiting

  • Mirati Research Site

    New York, New York 10016
    United States

    Active - Recruiting

  • Mirati Research Site

    New York, New York 10065
    United States

    Active - Recruiting

  • Mirati Research Site

    Chapel Hill, North Carolina 27514
    United States

    Active - Recruiting

  • Mirati Research Site

    Cincinnati, Ohio 45219
    United States

    Active - Recruiting

  • Mirati Research Site

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

  • Mirati Research Site

    Kettering, Ohio 45429
    United States

    Active - Recruiting

  • Mirati Research Site

    Eugene, Oregon 97401
    United States

    Active - Recruiting

  • Mirati Research Site

    Allentown, Pennsylvania 18103
    United States

    Active - Recruiting

  • Mirati Research Site

    Charleston, South Carolina 29425
    United States

    Active - Recruiting

  • Mirati Research Site

    Charleston, South Carolina 29414
    United States

    Active - Recruiting

  • Mirati Research Site

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • Mirati Research Site

    Austin, Texas 78731
    United States

    Active - Recruiting

  • Mirati Research Site

    Dallas, Texas 75246
    United States

    Active - Recruiting

  • Mirati Research Site

    Dallas, Texas 75231
    United States

    Active - Recruiting

  • Mirati Research Site

    Dallas, Texas 75231
    United States

    Active - Recruiting

  • Mirati Research Site

    Fort Worth, Texas 76104
    United States

    Active - Recruiting

  • Mirati Research Site

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Mirati Research Site

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • Mirati Research Site

    Sugar Land, Texas 77479
    United States

    Active - Recruiting

  • Mirati Research Site

    Tyler, Texas 75702
    United States

    Active - Recruiting

  • Mirati Research Site

    Fairfax, Virginia 22031
    United States

    Active - Recruiting

  • Mirati Research Site

    Newport News, Virginia 23606
    United States

    Active - Recruiting

  • Mirati Research Site

    Seattle, Washington 98109
    United States

    Active - Recruiting

  • Mirati Research Site

    Vancouver, Washington 98684
    United States

    Active - Recruiting

  • Mirati Research Site

    Madison, Wisconsin 53792
    United States

    Active - Recruiting

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