Study of RMC-5127 in Patients With Advanced KRAS G12V-Mutant Solid Tumors
Recruiting · NCT07349537 · Interventional (participants receive a specific treatment) · Lead sponsor: Revolution Medicines, Inc.
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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.
Exclusion criteria
- Primary central nervous system (CNS) tumors
- Prior therapy with KRAS G12V inhibitor or direct RAS-targeted therapy (eg. degraders and/or inhibitors).
- Any conditions that may affect the ability to take or absorb study drug.
- Major surgery within 28 days prior to receiving study drug(s).
- Patient is unable or unwilling to comply with protocol-required study visits or procedures.
Where it is running
9 locations listed across 7 US states.
- Yale Cancer Center - New Haven, Connecticut, United States
- Johns Hopkins - Baltimore, Maryland, United States
- Dana-Farber Cancer Institute - Boston, Massachusetts, United States
- START Midwest - Grand Rapids, Michigan, United States
- Laura and Isaac Perlmutter Cancer Center at NYU Langone Health - New York, New York, United States
- NEXT - Dallas - Dallas, Texas, United States
- NEXT - San Antonio, Texas, United States
- START - San Antonio - San Antonio, Texas, United States
- NEXT - Virginia - Fairfax, Virginia, United States