Study of RMC-5127 in Patients With Advanced KRAS G12V-Mutant Solid Tumors
Part of paid clinical trials in Grand Rapids, Michigan.
- Sponsor
- Revolution Medicines, Inc.
- Study ID
- NCT07349537
- Phase
- PHASE1
- Status
- Recruiting
Conditions
- Advanced Solid Tumors
- CRC
- Colorectal Cancer (CRC)
- Lung Cancer (NSCLC)
- NSCLC
- Non-small Cell Lung Cancer (NSCLC)
- PDAC
- Pancreatic Adenocarcinoma
- Pancreatic Cancer
- Pancreatic Ductal Adenocarcinoma (PDAC)
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- RMC-5127 — DRUGoral tablets
- daraxonrasib — DRUGoral tablets
- cetuximab — DRUGIV infusion
Study Details
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of RMC-5127 as a monotherapy and in combination with either daraxonrasib or cetuximab in adults with KRAS G12V-mutant solid tumors.
Key Dates
- Start date
- Jan 8, 2026
- Status verified
- May 2026
- Primary completion
- Apr 30, 2028
- Completion
- Oct 31, 2028
Study Design
- Enrollment
- 574 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Arm A: RMC-5127 MonotherapyDose Escalation and Dose Expansion
- Experimental: Arm B: RMC-5127 + Daraxonrasib CombinationDose Escalation and Dose Expansion
- Experimental: Arm C: RMC-5127 + Cetuximab CombinationDose Escalation and Dose Expansion
Primary Outcome Measure
Number of patients with adverse events (AEs) [ Time Frame: Up to approximately 3 years ]
Central Contacts
- Revolution Medicines Study Director1-844-2-REVMED
Locations (5)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| START Midwest | Grand Rapids | Michigan | 49546 | 616-954-5554 |
| NEXT - Dallas | Dallas | Texas | 75039 | |
| NEXT | San Antonio | Texas | 78229 | |
| START - San Antonio | San Antonio | Texas | 78229 | |
| NEXT - Virginia | Fairfax | Virginia | 22031 |
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