Clinical Trials /

MRTX849 in Patients With Cancer Having a KRAS G12C Mutation

NCT03785249

Description:

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.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: MRTX849 in Patients With Cancer Having a KRAS G12C Mutation
  • Official Title: A Phase 1/2 Multiple Expansion Cohort Trial of MRTX849 in Patients With Advanced Solid Tumors With KRAS G12C Mutation

Clinical Trial IDs

  • ORG STUDY ID: 849-001
  • NCT ID: NCT03785249

Conditions

  • Advanced Cancer
  • Metastatic Cancer
  • Malignant Neoplastic Disease

Interventions

DrugSynonymsArms
MRTX849Phase 1 Dose Exploration

Purpose

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.

Detailed Description

      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.
    

Trial Arms

NameTypeDescriptionInterventions
Phase 1 Dose ExplorationExperimentalDose escalation of MRTX849 to determine maximum tolerated dose
  • MRTX849
Phase 1b ExpansionExperimentalExpansion cohort to ensure sufficient safety experience, pharmacokinetic information, and early evidence of clinical activity of MRTX849 to recommend Phase 2 regimens
  • MRTX849
Phase 2ExperimentalSeparate cohorts of patients stratified by histological diagnosis for evaluation of clinical activity of MRTX849
  • MRTX849

Eligibility Criteria

        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:

          -  Active brain metastases

          -  History of intestinal disease or major gastric surgery or inability to swallow oral
             medications

          -  Other active cancer
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Characterize the safety of MRTX849 in patients having advanced solid tumor malignancies with KRAS G12C mutation
Time Frame:20 months
Safety Issue:
Description:Number of participants with treatment related adverse events

Secondary Outcome Measures

Measure:Establish maximum tolerated dose
Time Frame:12 months
Safety Issue:
Description:Number of participants with dose limiting toxicity
Measure:Evaluate clinical activity of MRTX849
Time Frame:20 months
Safety Issue:
Description:Objective response rate in accordance with Response Evaluation Criteria in Solid Tumors (RECIST)

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Mirati Therapeutics Inc.

Trial Keywords

  • KRAS
  • NSCLC
  • Colorectal Cancer
  • Colon Cancer
  • Metastatic Cancer

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