Study of MRTX1133 in Patients With Advanced Solid Tumors Harboring a KRAS G12D Mutation
A Phase 1/2 Multiple Expansion Cohort Trial of MRTX1133 in Patients With Advanced Solid Tumors Harboring a KRAS G12D Mutation
Sponsor: Mirati Therapeutics Inc.
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
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
Secondary Endpoints
Area under plasma concentration versus time curve (AUC)
Time to achieve maximal plasma concentration (Tmax)
Maximum observed plasma concentration (Cmax)
Eligibility Criteria
Inclusion Criteria: * Histologically confirmed diagnosis of a solid tumor malignancy harboring KRAS G12D mutation in tumor tissue or ctDNA. * Unresectable or metastatic disease. * Patients must have received standard therapies appropriate for their tumor type and stage; first-line treatment for PDAC for certain cohorts. * Presence of tumor lesions to be evaluated per RECIST v1.1: 1. in the Phase 1 dose escalation cohorts, patients must have measurable or evaluable disease. 2. in the Phase 1b and Phase 2 cohorts, patients must have measurable disease. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Adequate organ function. * Age ≥ 18 years Exclusion Criteria: * Active brain metastases or carcinomatous meningitis. * Prior treatment with a KRAS G12D inhibitor (Phase 1b \& Phase 2 only). * History of significant hemoptysis or hemorrhage within 4 weeks of the first dose of study treatment. * History of intestinal disease, inflammatory bowel disease, major…
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