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A First-in-human Study of RLY-8161 in Advanced NRAS-Mutant Solid Tumors
RecruitingPhase 1
A First-in-human Study of RLY-8161 for Treatment of Advanced NRAS-Mutant Melanoma and Other Solid Tumors
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
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.
About the study
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.
What is being tested
- RLY-8161 (drug)
Sponsor: Relay Therapeutics, Inc. · Participants: 35 · Started: Mar 9, 2026
Contact the study team
- Relay Therapeutics, Inc · Phone: 617-322-0731
Official record on ClinicalTrials.gov — NCT07584226
Locations in the U.S.
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.