This study will evaluate the safety and clinical activity of MRTX849 (adagrasib) in combination with palbociclib in patients with advanced solid tumor malignancies with KRAS G12C mutation.
This study will evaluate the pharmacokinetics and preliminary clinical activity of MRTX849 (adagrasib) in combination with palbociclib in patients with advanced solid tumor malignancies with KRAS G12C mutation. MRTX849 is an orally available small molecule inhibitor of KRAS G12C and palbociclib is a small molecule inhibitor of CDK 4 and 6.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
11
KRAS G12C inhibitor
CDK 4 and 6 inhibitor
Local Institution - 804
Orlando, Florida, United States
Local Institution - 803
Nashville, Tennessee, United States
Local Institution - 802
Houston, Texas, United States
Local Institution - 801
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 emergent adverse events
Time frame: 24 months
Evaluate Pharmacokinetics of the combination regimen
Plasma concentration
Time frame: 24 months
Establish Maximum Tolerated Dose
Number of patients with dose limiting toxicity
Time frame: 24 months
Evaluate preliminary clinical activity of the combination regimen
Objective response rate in accordance with Response Evaluation Criteria in Solid Tumors (RECIST)
Time frame: 24 months
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