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

Sponsor: Mirati Therapeutics Inc.

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT03785249

Patient View

This Phase 1/2 study assesses the safety, tolerability, pharmacokinetics, and clinical activity of MRTX849 in patients with advanced solid tumors with a KRAS G12C mutation. Eligible patients have unresectable or metastatic disease. Interventions include oral MRTX849, intravenous pembrolizumab and cetuximab, and oral afatinib, depending on cohort assignment.

Patient Parameters

Program 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.

Description

This study will evaluate the safety, tolerability, pharmacokinetics, metabolites, pharmacodynamics, and clinical activity of MRTX849 (adagrasib) in patients with advanced solid tumors with a KRAS G12C mutation. MRTX849 (adagrasib) is an orally-available small molecule inhibitor of KRAS G12C.

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; first-line treatment for NSCLC for certain cohorts
  • Adequate organ function

Exclusion Criteria

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

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