Study of Elironrasib and Daraxonrasib as Monotherapies and Combination Therapy in Participants With Advanced KRAS G12C Mutant Solid Tumors
Phase 1b/2, Multicenter, Open-label, Dose Escalation and Dose Expansion Study of Elironrasib and Daraxonrasib as Monotherapies and Combination Therapy in Patients With Advanced KRAS G12C-Mutated Solid Tumors
Sponsor: Revolution Medicines, Inc.
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Number of patients with adverse events (AEs) in Phase 1b
Time frame: Up to approximately 3 years
Changes in vital signs in Phase 1b
Time frame: Up to approximately 3 years
Changes in clinical laboratory test values in Phase 1b
Time frame: Up to approximately 3 years
Dose Limiting Toxicities in Phase 1b
Time frame: 21 days
Secondary Endpoints
Maximum Observed Blood Concentration of Elironrasib and Daraxonrasib
Time to Reach Maximum Blood Concentration of Elironrasib and Daraxonrasib
Area Under Blood Concentration Time Curve of Elironrasib and Daraxonrasib
Eligibility Criteria
Inclusion Criteria: * 18 years of age * Histology: pathologically documented, KRAS G12C-mutated, advanced or metastatic solid tumors not amendable to curative therapy 1. Phase 1b Dose Escalation: solid tumors, previously treated 2. Phase 1b Dose Expansion and Phase 2: i. NSCLC, previously treated with immunotherapy, chemotherapy, and KRAS G12C (OFF) inhibitors ii. Solid tumors, previously treated, naïve to KRAS G12C (OFF) inhibitors. * ECOG performance status 0 or 1 * Adequate organ function Exclusion Criteria: * Primary central nervous system (CNS) tumors * Active brain metastases * Known impairment of GI function that would alter the absorption * Major surgical procedures within 28 days or non-study related minor procedures within 7 days of treatment
✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
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