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New treatment option for Non-small Cell Lung Cancer (NSCLC)
Official title Study of RMC-5127 in Patients With Advanced KRAS G12V-Mutant Solid Tumors
ClinicalTrials.gov ID: NCT07349537
What this study is testing
What is RMC-5127?
RMC-5127 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for non-small cell lung cancer (nsclc).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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.
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- New Haven, Connecticut, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- Grand Rapids, Michigan, United States
- New York, New York, United States
- Dallas, Texas, United States
- San Antonio, Texas, United States
- Fairfax, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Haven, Connecticut, United States; Baltimore, Maryland, United States; Boston, Massachusetts, United States; Grand Rapids, Michigan, United States; New York, New York, United States; Dallas, Texas, United States and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.