NCT06128551 Study of Elironrasib and Daraxonrasib as Monotherapies and Combination Therapy in Participants With Advanced KRAS G12C Mutant Solid Tumors
| NCT ID | NCT06128551 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Revolution Medicines, Inc. |
| Condition | Non-Small Cell Lung Cancer (NSCLC) |
| Study Type | INTERVENTIONAL |
| Enrollment | 534 participants |
| Start Date | 2023-11-14 |
| Primary Completion | 2028-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 534 participants in total. It began in 2023-11-14 with a primary completion date of 2028-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Revolution Medicines, Inc.
STUDY DIRECTOR
Revolution Medicines, Inc.
Frequently Asked Questions
Who can join the NCT06128551 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Non-Small Cell Lung Cancer (NSCLC). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06128551 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06128551 currently recruiting?
Yes, NCT06128551 is actively recruiting participants. Contact the research team at medinfo@revmed.com for enrollment information.
Where is the NCT06128551 trial being conducted?
This trial is being conducted at Duarte, United States, Orange, United States, Sacramento, United States, Stanford, United States and 11 additional locations.
Who is sponsoring the NCT06128551 clinical trial?
NCT06128551 is sponsored by Revolution Medicines, Inc.. The principal investigator is Revolution Medicines, Inc. at Revolution Medicines, Inc.. The trial plans to enroll 534 participants.
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