NCT07584226 · Relay Therapeutics, Inc.
A First-in-human Study of RLY-8161 in Advanced NRAS-Mutant Solid Tumors
What this study is about
This is a Phase 1 first-in-human, where both patients and doctors know the treatment given conducted at multiple hospitals study designed to evaluate the safety, tolerability, how the drug moves through the body (PK), how the drug affects the body, and preliminary antitumor activity of RLY-8161, an NRAS-selective inhibitor, in participants with advanced NRAS-mutant melanoma and other solid tumors.
View original scientific description
This is a Phase 1 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 and other solid tumors.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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, or BRAF mutation or known alterations in other driver oncogenes.
- 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 that are associated with progressive neurologic symptoms or require ongoing corticosteroids to control the CNS disease.
Where
- Los Angeles, California
- San Francisco, California
- Aurora, Colorado
- Boston, Massachusetts
- Grand Rapids, Michigan
- New York, New York
- Nashville, Tennessee
- Fairfax, Virginia
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 2, 2026 · Source of record for eligibility and locations