NCT07349537RecruitingPhase 1
Study of RMC-5127 in Patients With Advanced KRAS G12V-Mutant Solid Tumors
Phase 1/1b, Multicenter, Open-Label, Study of RMC-5127 in Patients With Advanced KRAS G12V-Mutant Solid Tumors
Source: ClinicalTrials.gov · Last updated 17 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 574 (estimated)
- First submitted
- 9 Jan 2026
- Start date
- Jan 2026
- Primary completion date
- Apr 2028
- Lead sponsor
- Revolution Medicines, Inc.
- Diseases
- Lung cancer, Pancreatic cancer, Colorectal cancer
- NCT number
- NCT07349537
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 574
- From Jan 2026 to the primary completion date, Apr 2028
- 9 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior therapy with KRAS G12V inhibitor or direct RAS-targeted therapy (eg. degraders and/or inhibitors).
- Major surgery within 28 days prior to receiving study drug(s).
Other illness
- Any conditions that may affect the ability to take or absorb study drug.
Other
- Primary central nervous system (CNS) tumors
- Patient is unable or unwilling to comply with protocol-required study visits or procedures.
Who the study is looking for
- At least 18 years old and has provided informed consent.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Pathologically documented, locally advanced or metastatic KRAS G12V-mutated solid tumor malignancy.
- Received and progressed or been intolerant to prior standard therapy (including targeted therapy) appropriate for tumor type and stage.
- Measurable per RECIST v1.1
- Adequate organ function (bone marrow, liver, kidney, coagulation).
- Able to take oral medications.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (9)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Johns Hopkins Coordinator of this site? Confirm its status | Baltimore | United States | Recruiting |
| Dana-Farber Cancer Institute Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| NEXT Dallas Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
| NEXT Virginia Coordinator of this site? Confirm its status | Fairfax | United States | Recruiting |
| START | Midwest Coordinator of this site? Confirm its status | Grand Rapids | United States | Recruiting |
| Yale Cancer Center Coordinator of this site? Confirm its status | New Haven | United States | Recruiting |
| Laura and Isaac Perlmutter Cancer Center at NYU Langone Health Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| START | San Antonio Coordinator of this site? Confirm its status | San Antonio | United States | Recruiting |
| NEXT Coordinator of this site? Confirm its status | San Antonio | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.