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): GI (ONC), 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