Recruiting nowPhase 1
What this trial is trying to do
The researchers are testing whether RMC-5127, a drug aimed at the KRAS G12V form of the KRAS cancer protein, can be given safely alone or with daraxonrasib or cetuximab. They will examine how the drugs behave in the body and look for early signs that they affect the cancer.
The idea is that targeting the specific KRAS change, alone or alongside another RAS-directed drug or cetuximab, might control tumours with this mutation. The main measure is safety and tolerability, with preliminary tumour activity also assessed; there is no comparison group and the trial is not designed to show whether people live longer.
Worth knowing: This is a non-randomised phase 1 trial, so it is primarily testing dose and safety rather than proving benefit.
Written from the trial's own registry entry to explain what the researchers are testing and why. Nothing here is a result — this trial has not reported one — and it is not a view on whether the treatment works or on whether it would suit you.
| Registry number | NCT07349537 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 1 |
| Design | not randomised, open label |
| Taking part | 574 people (planned) |
| Who can join | aged 18 Years and over |
| Run by | Revolution Medicines, Inc. |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Drug RMC-5127
- Drug daraxonrasib
- Drug cetuximab
What it is measuring
Number of patients with adverse events (AEs)
This is the trial's main question — the one it is designed and sized to answer. Anything else it reports is a secondary finding, and secondary findings are far more likely to be chance.
Phase 1. Tests safety and dose in a small group. Some people do benefit, but that is not what the trial is designed to find out.
How the researchers describe it
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.
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- Any genotype
- Metastatic
- Locally advanced
Read automatically from the criteria below, to make the list searchable. It is a summary of what the text mentions, not a decision about whether you qualify — and where the two disagree, the criteria are right and this is wrong.
Who the trial is looking for
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.
This is an extract. Whether you qualify is decided by the trial team against the full criteria, not by reading this page. Read the full eligibility criteria
Where it is running
Running at 9 sites. Listed in: United States.
Individual hospitals, and whether each is currently open, are listed on the registry record. Sites open and close throughout a trial.
Worth asking your oncology team
Being listed here is not a recommendation, and no one page can tell you whether a trial is right for you. These are the questions it raises.
- Is this trial open at a hospital I could realistically travel to?
- Given my stage, my previous treatment and my tumour's molecular profile, would I be eligible?
- What would I be giving up by joining — is the comparison arm the treatment I would otherwise be having?
- What is already known about the safety of what is being tested?
The source
Registry record NCT07349537, registered by Revolution Medicines, Inc. on ClinicalTrials.gov, a public database run by the US National Library of Medicine. The details on this page come from that record and are only ever as current as the sponsor has kept it.
This is a listing of a registered clinical trial, reproduced for information. It is not a recommendation, this site has no connection to the trial or its sponsor, and being listed here says nothing about whether the treatment works. Talk to your own oncology team before pursuing any trial.
This article summarises published research for general information. It is not medical advice, and it is not a substitute for a conversation with your own oncology team, who know your case. Do not start, stop, or change any treatment or supplement on the basis of what you read here.