Recruiting nowPhase 2
What this trial is trying to do
The researchers are testing RLY-8161, an inhibitor designed to selectively block NRAS, in advanced cancers whose cells carry an NRAS mutation. The idea is that disrupting this growth signal may slow tumour growth, but the trial is first establishing how safely the drug can be given and whether there are early signs of tumour control.
There is no comparison treatment: the trial is mainly measuring the maximum tolerated dose and the recommended dose for later studies, along with drug levels and preliminary tumour activity. Any improvement being assessed at this stage is chiefly tolerability and signs that the cancer may respond, not longer survival or a longer time before progression.
Worth knowing: This is an early, open-label, non-randomised study, so it is designed primarily to assess safety and dosing rather than prove that RLY-8161 works better than existing treatment.
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 | NCT07584226 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 2 |
| Design | not randomised, open label |
| Taking part | 180 people (planned) |
| Who can join | aged 18 Years and over |
| Run by | Relay Therapeutics, Inc. |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Drug RLY-8161
What it is measuring
Part 1: Maximum Tolerated Dose (MTD) and/or RP2D of RLY-8161
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 2. Tests whether the treatment works well enough to be worth a larger trial. Usually too small to prove it changes survival.
How the researchers describe it
This is a Phase 1/2 first-in-human, open-label multicenter study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of RLY-8161, an NRAS-selective inhibitor, in participants with advanced NRAS-mutant melanoma, colorectal and other solid tumors.
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- (K/N)RAS mutated
- G12D
- G12V
- G13D
- Other codon
- 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
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
- Histologically confirmed diagnosis of unresectable Stage III or IV melanoma or other solid tumor.
- Disease is refractory to standard therapy (including targeted therapy), participant is intolerant of standard therapy, or participant has declined standard therapy.
- Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
- One or more documented primary oncogenic NRAS mutation(s).
Exclusion Criteria
- Known activating KRAS, HRAS, BRAF, or EGFR mutation or known alterations in other driver oncogenes that are recognized as actionable oncogenic drivers for the participant's specific tumor type.
- Prior treatment with ERK, MEK, RAF, or RAS targeting agents or any agent whose mechanism of action is to inhibit the RAS-MAPK pathway.
- For participants with melanoma: lactate dehydrogenase (LDH) >2×ULN.
- Central nervous system (CNS) metastases associated with progressive neurologic symptoms or requiring ongoing corticosteroids to control the CNS disease.
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 NCT07584226, registered by Relay Therapeutics, 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.