A Phase 1/2 study of MRTX1133 in solid tumors harboring a KRAS G12D mutation.
This first-in-human clinical trial will begin with an exploration of MRTX1133 dose and regimen. As potentially viable regimens are identified, Phase 1b expansion cohorts may be implemented to ensure collection of sufficient safety and PK information, and early evidence of clinical activity are available to recommend Phase 2 regimens. In Phase 2, separate cohorts of patients by histological diagnosis and/or baseline characteristics will be evaluated for the clinical activity and efficacy of MRTX1133. This study was terminated prior to phase 2 initiating. Only phase 1 of the study was conducted.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
63
KRAS G12D Inhibitor
Local Institution - 311
Phoenix, Arizona, United States
Local Institution - 309
New Haven, Connecticut, United States
Local Institution - 301
Lady Lake, Florida, United States
Phase 1: Number of Patients who Experience Dose-Limiting Toxicity
Time frame: 21 Days
Phase 1/1b: Number of patients who experience a treatment-related adverse event
Time frame: Up to 2 years
Phase 2: Objective response rate (ORR)
Time frame: 2 years
Phase 2: Duration of response (DOR)
Time frame: 2 years
Phase 2: Progression free survival (PFS)
Time frame: 2 years
Phase 2: Overall survival (OS)
Time frame: 2 years
Area under plasma concentration versus time curve (AUC)
Time frame: up to 4 days
Time to achieve maximal plasma concentration (Tmax)
Time frame: up to 4 days
Maximum observed plasma concentration (Cmax)
Time frame: up to 4 days
Terminal elimination half-life (t1/2)
Time frame: up to 4 days
Apparent total plasma clearance when dosed orally (CL/F)
Time frame: up to 4 days
Apparent volume of distribution when dosed orally (Vz/F)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Local Institution - 306
Baltimore, Maryland, United States
Local Institution - 308
Boston, Massachusetts, United States
Local Institution - 310
Boston, Massachusetts, United States
Local Institution - 314
Grand Rapids, Michigan, United States
Local Institution - 312
New York, New York, United States
Local Institution - 303
Nashville, Tennessee, United States
Local Institution - 302
Houston, Texas, United States
...and 4 more locations
Time frame: up to 4 days