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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

Sponsor: Relay Therapeutics, Inc. · Participants: 35 · Started: Mar 9, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07584226

Locations in the U.S.

CaliforniaUniversity of California, Los Angeles, Los Angeles
University of California, San Francisco, San Francisco
ColoradoUniversity of Colorado Hospital, Aurora
MassachusettsDana Farber Cancer Institute, Boston
Massachusetts General Hospital, Boston
MichiganSTART Midwest, LLC, Grand Rapids
New YorkMemorial Sloan Kettering Cancer Center, New York
TennesseeSarah Cannon Research Institute Oncology Partners, Nashville
VirginiaNEXT Virginia, Fairfax

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.