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

Updated on 22 November 2021
solid tumor
advanced solid tumor
malignant solid tumor


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.


  • 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.

Condition Non-Small Cell Lung Cancer, Metastatic Cancer, Solid Tumors, Colon Cancer
Clinical Study IdentifierTX223046
Last Modified on22 November 2021


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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