This study will evaluate safety, tolerability, drug levels, molecular effects and clinical activity of MRTX849 (adagrasib) in combination with BI 1701963 in patients with advanced solid tumors that have a KRAS G12C mutation.
This study will evaluate safety, tolerability, pharmacokinetics, metabolites, pharmacodynamics and clinical activity of MRTX849 (adagrasib) in combination with BI 1701963 in patients with advanced solid tumors with a KRAS G12C mutation. MRTX849 is an orally available small molecule inhibitor of KRAS G12C and BI 1701963 is a SOS1 pan-KRAS inhibitor.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
7
KRAS G12C inhibitor
SOS1 Inhibitor
Washington University School of Medicine
St Louis, Missouri, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
MD Anderson Cancer Center
Houston, Texas, United States
Next Oncology
San Antonio, Texas, United States
Characterize the number of patients with treatment emergent adverse events of the combination regimen in patients with advanced solid tumor malignancies with KRAS G12C mutation
Number of participants with treatment related adverse events
Time frame: 20 months
Evaluate Pharmacokinetics of the combination regimen
Blood plasma concentration
Time frame: 20 months
Establish Maximum Tolerated Dose
Number of patients with dose limiting toxicity
Time frame: 12 months
Evaluate preliminary clinical activity of the combination regimen
Objective response rate in accordance with Response Evaluation Criteria in Solid Tumors (RECIST)
Time frame: 20 months
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