Study of Elironrasib and Daraxonrasib as Monotherapies and Combination Therapy in Participants With Advanced KRAS G12C Mutant Solid Tumors
Sponsor: Revolution Medicines, Inc.
ClinicalTrials ID:NCT06128551
This open-label, multicenter Phase 1b/2 study evaluates the safety, tolerability, and PK profiles of Elironrasib and Daraxonrasib, both as monotherapies and in combination, in patients with advanced KRAS G12C-mutated solid tumors. Eligible participants are adults with specific tumor profiles and adequate organ function. The study aims to determine MTD, RP2DS, and assess antitumor activity.
Patient Parameters
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Program Overview
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.
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.
Eligibility Criteria
Inclusion Criteria
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18 years of age
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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.
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ECOG performance status 0 or 1
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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
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| City of Hope | 91010 | Duarte | California |
| UC IRVINE Health | 92868 | Orange | California |
| UC Davis Comprehensive Cancer Center | 95817 | Sacramento | California |
| Stanford Cancer Institute | 94305 | Stanford | California |
| University of Colorado Cancer Center | 80045 | Aurora | Colorado |
| Florida Cancer Specialists | 34232 | Sarasota | Florida |
| Moffitt Cancer Center and Research Institute | 33612 | Tampa | Florida |
| Dana Farber Cancer Institute | 02215 | Boston | Massachusetts |
| Henry Ford Cancer | 48202 | Detroit | Michigan |
| START Midwest | 49546 | Grand Rapids | Michigan |
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