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Trial ID CA239-0008  |   NCT03785249

Phase 1/2 Study of MRTX849 in Patients With Cancer Having a KRAS G12C Mutation KRYSTAL-1

Summary

  • Phase 1/Phase 2
  • Male and Female Gender icon
  • 18+
    Age Range
  • 221
    Locations
  • BMS Recruiting Study icon
    Recruiting

Overview

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

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Key Eligibility Criteria

Inclusion Criteria

Inclusion Criteria Icon img
:
  • Histologically confirmed diagnosis of a solid tumor malignancy with KRAS G12C mutation
    1. Unresectable or metastatic disease
      1. Standard treatment is not available or patient declines; first-line treatment for NSCLC for certain cohorts
        1. Adequate organ function

          Exclusion Criteria

          Exclusion Criteria Icon
          :
          • History of intestinal disease or major gastric surgery or inability to swallow oral medications
            1. Other active cancer
              Additional Information *

              Treatment Options

              Study Arms

              ASSIGNED INTERVENTION

              Study Arms

              Experimental: Phase 1 Dose Exploration

              ASSIGNED INTERVENTION
              • Drug: MRTX849

              Study Arms

              Experimental: Phase 1b Expansion

              ASSIGNED INTERVENTION
              • Drug: MRTX849

              Study Arms

              Experimental: Phase 2

              ASSIGNED INTERVENTION
              • Drug: MRTX849

              Study Arms

              Experimental: Phase 2 Combination with Cetuximab

              ASSIGNED INTERVENTION
              • Drug: MRTX849, Cetuximab

              Study Arms

              Experimental: Pilot Phase 1b Combination with Afatinib

              ASSIGNED INTERVENTION
              • Drug: MRTX849, Afatinib

              Study Arms

              Experimental: Pilot Phase 1b Combination with Cetuximab

              ASSIGNED INTERVENTION
              • Drug: MRTX849, Cetuximab

              Study Arms

              Experimental: Pilot Phase 1b Combination with Cetuximab in NSCLC

              ASSIGNED INTERVENTION
              • Drug: MRTX849, Cetuximab

              Study Arms

              Experimental: Pilot Phase 1b Combination with Cetuximab in PDAC

              ASSIGNED INTERVENTION
              • Drug: MRTX849, Cetuximab

              Study Arms

              Experimental: Pilot Phase 1b Combination with Pembrolizumab

              ASSIGNED INTERVENTION
              • Drug: MRTX849, Pembrolizumab
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