Clinical Trial Details

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

Categories (click each to see list of all clinical trials associated with that category): Thoracic (ONC)

Current Status: Open

Phase: I/II (Cancer Control)

Principal Investigator: Ganti, Apar

Contact Information:
Kimberly Shields
kimberly.shields@unmc.edu

Eligibility: https://clinicaltrials.gov/study/NCT03785249?term=NCT03785249&rank=1

Summary
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 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 Exploratory Objectives To explore correlations between MRTX849 exposure and patient outcomes such as disease response, safety and pharmacodynamic endpoints To evaluate population PK parameters To characterize metabolites of MRTX849 in blood plasma To evaluate the concentrations of MRTX849 and potential metabolites in CSF To evaluate the utility of detection of KRAS G12C mutations in plasma to identify the study population To explore potential pharmacodynamic (PD) markers of KRAS inhibition in tumor tissue and/or blood plasma To explore correlations between baseline tumor biomarkers, gene alterations and clinical activity/efficacy