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

  • STATUS
    Recruiting
Updated on 8 March 2021
solid tumor
advanced solid tumor
malignant solid tumor

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.

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.

Details
Condition Non-Small Cell Lung Cancer, Solid Tumors, Colon Cancer, Metastatic Cancer
Clinical Study IdentifierTX223046
Last Modified on8 March 2021

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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