A Phase 1/2 Multiple Expansion Cohort Trial of MRTX849 in Patients With Advanced Solid Tumors With KRAS G12C Mutation
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- STATUS
- Recruiting
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, Metastatic Cancer, Solid Tumors, Colon Cancer |
|---|---|
| Clinical Study Identifier | TX223046 |
| Last Modified on | 22 November 2021 |
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