RecruitingPhase 1Phase 2NCT06128551
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.
Enrollment
534 participants
Start Date
Nov 14, 2023
Study Type
INTERVENTIONAL
Summary
This study is to evaluate the safety, tolerability, and PK profiles of Elironrasib and Daraxonrasib as monotherapies and combination therapy in patients with KRAS G12C-mutated solid tumors.
Eligibility
Min Age: 18 Years
Inclusion Criteria7
- years of age
- Histology: pathologically documented, KRAS G12C-mutated, advanced or metastatic solid tumors not amendable to curative therapy
- Phase 1b Dose Escalation: solid tumors, previously treated
- 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 Criteria4
- 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
Interventions
DRUGElironrasib
oral tablets
DRUGDaraxonrasib
oral tablets
Locations(53)
View Full Details on ClinicalTrials.gov
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NCT06128551