Objectives
All Phases
- To characterize the safety and tolerability of MRTX849 in patients having advanced solid tumor malignancies with KRAS G12C mutation
- To evaluate the pharmacokinetics (PK) of MRTX849
Phase 1/1b Cohorts
- To establish the maximum tolerated dose (MTD) using one or more dosing regimens
- To conduct an initial evaluation the PK and tolerability of MRTX849 administered with food
- To evaluate biologically relevant dose levels
- To identify recommended Phase 2 doses (RP2Ds) and regimens of MRTX849
- To evaluate the clinical activity of MRTX849 in the Phase 1 population
Phase 2 Cohorts
- To evaluate the clinical activity/efficacy of MRTX849 in cohorts of patients having selected solid tumor malignancies with KRAS G12C mutation
Expansion Cohort Sub-Studies
- To evaluate the PK of new MRTX849 oral formulations
- To fully evaluate the PK of MRTX849 administered in the fed and fasted states
- Pilot Phase 1 combination sub-studies
- To characterize the safety and tolerability of MRTX849 administered in combination with selected cancer therapeutic agents to patients having advanced solid tumor malignancies with KRAS G12C mutation
- To characterize the PK of MRTX849 administered in combination regimens
- To determine the RP2D of MRTX849 administered in combination regimens
- To evaluate the clinical activity of MRTX849 administered in combination with selected cancer therapeutic agents