A Phase I/II Multiple Expansion Cohort Trial of MRTX849 in Patients with Advanced Solid Tumors with KRAS G12C mutation (MRT849-001)
Objective
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 of 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 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 with food
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
