Clinical Studies Search

Protocol Summary


Protocol No.
PSCI-19-097
Prinicipal Investigator
Ma, Patrick
Phase
Phase I/II
Age Group
Adult
Scope
National
Secondary Protocol No.
MRT849-001 , (KRYSTAL-1)
Title
A Phase I/II Multiple Expansion Cohort Trial of MRTX849 in Patients with Advanced Solid Tumors with KRAS G12C mutation (KRYSTAL-1) (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


Applicable Disease Sites
Lung

Other Gastrointestinal
Status
Open
Participating Institutions
Hershey Medical Center