This study will evaluate the safety, tolerability, drug levels, molecular effects, and clinical activity of MRTX849 (adagrasib) in patients with advanced solid tumors that have a KRAS G12C mutation.
This study will evaluate the safety, tolerability, pharmacokinetics, metabolites, pharmacodynamics, and clinical activity of MRTX849 (adagrasib) in patients with advanced solid tumors with a KRAS G12C mutation. MRTX849 (adagrasib) is an orally-available small molecule inhibitor of KRAS G12C.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
731
MRTX849 will be administered orally once or twice daily in a continuous regimen
Pembrolizumab is administered as an intravenous infusion once every 3 weeks
Cetuximab will be administered as an intravenous infusion once per week or once every 2 weeks
Characterize the safety of MRTX849 in patients having advanced solid tumor malignancies with KRAS G12C mutation
Number of participants with treatment related adverse events
Time frame: 20 months
Evaluate the pharmacokinetics of MRTX849
Blood plasma concentration
Time frame: 20 months
Evaluate clinical activity/efficacy of MRTX849
Objective response rate in accordance with Response Evaluation Criteria in Solid Tumors (RECIST)
Time frame: 20 months
Establish maximum tolerated dose
Number of participants with dose limiting toxicity
Time frame: 12 months
Characterize safety and tolerability of MRTX849 in combination with selected therapeutic agents
Number of participants with dose limiting toxicity
Time frame: 12 months
Evaluate the pharmacokinetics of new MRTX849 oral formulations
Blood plasma concentration
Time frame: 6 months
Evaluate the pharmacokinetics of MRTX849 administered with food
Blood plasma concentration
Time frame: 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Afatinib will be administered orally once a day in a continuous regimen
Local Institution - 001-826
Birmingham, Alabama, United States
Local Institution - 001-965
Anchorage, Alaska, United States
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Phoenix, Arizona, United States
Local Institution - 001-873-A
Tucson, Arizona, United States
Local Institution - 001-873
Tucson, Arizona, United States
Local Institution - 001-840-B
Bellflower, California, United States
Local Institution - 001-834
Beverly Hills, California, United States
Local Institution - 001-843
Duarte, California, United States
Local Institution - 001-850-K
Dublin, California, United States
Local Institution - 001-851
Fullerton, California, United States
...and 212 more locations