Study on Elironrasib and Daraxonrasib for Advanced KRAS G12C Mutant Solid Tumors
Sponsor: Revolution Medicines, Inc.
ClinicalTrials ID:NCT06128551
This clinical trial is testing the safety and effectiveness of two drugs, Elironrasib and Daraxonrasib, used alone and together, in treating advanced solid tumors with a specific KRAS G12C mutation.
Patient Parameters
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Program Overview
The purpose of this study is to evaluate how safe and tolerable the drugs Elironrasib and Daraxonrasib are when used alone or in combination for treating advanced solid tumors with a KRAS G12C mutation. Researchers aim to find the best dose for future studies and to see if these treatments can help shrink tumors.
Description
This study is divided into two phases: Phase 1b and Phase 2. In Phase 1b, researchers will test different doses of Elironrasib and Daraxonrasib, both alone and together, to find the highest dose that patients can tolerate without severe side effects. This phase will also expand to include more patients to further assess the combination therapy. In Phase 2, the study will focus on the most effective dose and schedule identified in Phase 1b, evaluating the safety and potential tumor-shrinking effects of the treatments.
Participants will receive either Elironrasib or Daraxonrasib alone, or a combination of both, and will be monitored for side effects and how well the treatment works against their cancer. The study aims to provide valuable information on the potential benefits of these drugs for patients with advanced KRAS G12C-mutated solid tumors.
Eligibility Criteria
Inclusion Criteria
- Be 18 years or older.
- Have a confirmed diagnosis of advanced or metastatic solid tumors with a KRAS G12C mutation that cannot be cured with standard treatments.
- For Phase 1b Dose Escalation: Have solid tumors that have been previously treated.
- For Phase 1b Dose Expansion and Phase 2:
- Have non-small cell lung cancer (NSCLC) previously treated with immunotherapy, chemotherapy, and KRAS G12C inhibitors.
- Have other solid tumors that have been previously treated but have not received KRAS G12C inhibitors.
- Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Have adequate organ function as determined by specific medical tests.
Exclusion Criteria
- Have primary tumors in the central nervous system (CNS).
- Have active cancer that has spread to the brain.
- Have known digestive system issues that could affect how the body absorbs the study drugs.
- Have had major surgery within the past 28 days or minor surgery not related to the study within the past 7 days before starting 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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