A First-in-human Study of RLY-8161 in Advanced NRAS-Mutant Solid Tumors

Recruiting now · Phase 1

Conditions studied: Advanced NRAS-Mutant Melanoma, Advanced NRAS-Mutant Solid Tumors, NRAS Mutation, NRAS G12D, NRAS G13R, NRAS G13D, NRAS G12V, NRAS Q61R, NRAS Q61K, NRAS Q61L, NRAS Q61H

In brief

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.

Key facts

Study ID

NCT07584226

Run by

Relay Therapeutics, Inc.

People needed

35

Starts

2026-03-09

Expected to finish

2029-12-31

Last updated by the study team

2026-07-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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 it is running

• University of California, Los Angeles — Los Angeles, California, United States (enrolling)
• University of California, San Francisco — San Francisco, California, United States (enrolling)
• University of Colorado Hospital — Aurora, Colorado, United States (enrolling)
• Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
• Dana Farber Cancer Institute — Boston, Massachusetts, United States (enrolling)
• START Midwest, LLC — Grand Rapids, Michigan, United States (enrolling)
• Memorial Sloan Kettering Cancer Center — New York, New York, United States (enrolling)
• Sarah Cannon Research Institute Oncology Partners — Nashville, Tennessee, United States (enrolling)
• NEXT Virginia — Fairfax, Virginia, United States (enrolling)

Full record on ClinicalTrials.gov

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