Purpose

This study will evaluate the safety, tolerability, drug levels, molecular effects, and clinical activity of MRTX849 in patients with advanced solid tumors that have a KRAS G12C mutation.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 Criteria

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

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Phase 1 Dose Exploration
Dose escalation of MRTX849 to determine maximum tolerated dose
  • Drug: MRTX849
    MRTX849 will be administered orally once or twice daily in a continuous regimen
Experimental
Phase 1b Expansion
Expansion cohort to ensure sufficient safety experience, pharmacokinetic information, and early evidence of clinical activity of MRTX849 to recommend Phase 2 regimens
  • Drug: MRTX849
    MRTX849 will be administered orally once or twice daily in a continuous regimen
Experimental
Phase 2
Separate cohorts of patients stratified by histological diagnosis for evaluation of clinical activity of MRTX849
  • Drug: MRTX849
    MRTX849 will be administered orally once or twice daily in a continuous regimen
Experimental
Pilot Phase 1b Combination with Pembrolizumab
Phase 1 evaluation of the safety, tolerability, PK and clinical activity of MRTX849 in combination with pembrolizumab in patients with NSCLC
  • Drug: MRTX849
    MRTX849 will be administered orally once or twice daily in a continuous regimen
  • Drug: Pembrolizumab
    Pembrolizumab is administered as an intravenous infusion once every 3 weeks
Experimental
Pilot Phase 1b Combination with Cetuximab
Phase 1 evaluation of the safety, tolerability, PK and clinical activity of MRTX849 in combination with cetuximab in patients with CRC
  • Drug: MRTX849
    MRTX849 will be administered orally once or twice daily in a continuous regimen
  • Drug: Cetuximab
    Cetuximab will be administered as an intravenous infusion once per week
Experimental
Pilot Phase 1b Combination with Afatinib
Phase 1 evaluation of the safety, tolerability, PK and clinical activity of MRTX849 in combination with afatinib in patients with NSCLC
  • Drug: MRTX849
    MRTX849 will be administered orally once or twice daily in a continuous regimen
  • Drug: Afatinib
    Afatinib will be administered orally once a day in a continuous regimen

Recruiting Locations

University of Alabama at Birmingham
Birmingham, Alabama 35294

More Details

Status
Recruiting
Sponsor
Mirati Therapeutics Inc.

Study Contact

Mirati Therapeutics Study Locator Services
1-844-893-5530
miratistudylocator@emergingmed.com

Detailed Description

This study will evaluate 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.