Study of Elironrasib and Daraxonrasib as Monotherapies and Combination Therapy in Participants With Advanced KRAS G12C Mutant Solid Tumors
NCT06128551 · Phase 1, Phase 2 · Duarte, California, United States
- Condition
- Stomach Cancer
- Disease stage
- Stage I-IV
- Phase
- Phase 1, Phase 2
- Study type
- DRUG
- Intervention
- Elironrasib, Daraxonrasib
- Age
- 18 Years to
- Gender
- All
- Sponsor
- Revolution Medicines, Inc.
- Research institution
- Revolution Medicines, Inc.
- Facility
- City of Hope
- Research center
- City of Hope
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.
Detailed description
This is an open-label, multicenter, Phase 1b/2 study evaluating elironrasib and daraxonrasib, administered as monotherapy and in combination, in patients with advanced KRAS G12C-mutated solid tumors to determine the maximum tolerated dose (MTD), identify the recommended Phase 2 dose and schedule (RP2DS), and preliminarily assess antitumor activity. The study includes a Phase 1b dose escalation and expansion of combination therapy, followed by a Phase 2 evaluation of the selected RP2DS as monotherapy and combination therapy to further assess safety and antitumor activity.
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
Primary outcomes
Number of patients with adverse events (AEs) in Phase 1b; Changes in vital signs in Phase 1b; Changes in clinical laboratory test values in Phase 1b
Secondary outcomes
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