Clinical Trial

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

Recruiting Phase 1
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Summary
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.
Protocol Amendment History 1 change
notable Trial sites expanded: 6 -> 9 locations 2026-07-03
Trial Details
NCT Number NCT07584226
Lead Sponsor Relay Therapeutics, Inc.
Conditions Advanced NRAS-Mutant Melanoma, Advanced NRAS-Mutant Solid Tumors, NRAS Mutation, NRAS G12D, NRAS G13R, NRAS G13D, NRAS G12V, NRAS Q61R +3 more
Enrollment 35 participants
Start Date 2026-03-09
Primary Completion 2027-12-30 (estimated)
Study Completion 2029-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-07-02