First test of RLY-8161 in advanced melanoma and other NRAS-mutant cancers
Tests RLY-8161, an NRAS-targeting drug, in adults with advanced NRAS-mutant melanoma or other solid tumors.
Plain-language title generated from the registry record
Registry title: A First-in-human Study of RLY-8161 in Advanced NRAS-Mutant Solid Tumors
Key facts
- Where
- Aurora, Boston, Fairfax, Grand Rapids, Los Angeles, Nashville, New York, and San Francisco, United StatesSee the 9 sites
- Phase
- Phase 1/2
Where in United States
- University of Colorado HospitalAurora, United StatesTaking people
- Dana-Farber Cancer InstituteBoston, United StatesTaking people
- Massachusetts General HospitalBoston, United StatesTaking people
- NEXT VirginiaFairfax, United StatesTaking people
- START Midwest, LLCGrand Rapids, United StatesTaking people
- University of California, Los AngelesLos Angeles, United StatesTaking people
- Sarah Cannon Research Institute - Oncology PartnersNashville, United StatesTaking people
- Memorial Sloan-Kettering Cancer CenterNew York, United StatesTaking people
- University of California San FranciscoSan Francisco, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Relay Therapeutics, Inc.
- Trial code
- NCT07584226
- Record updated
- 3 November 2026
- Original description
This is a Phase 1/2 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, colorectal and other solid tumors.Read full original descriptionShow less
A First-in-human Study of RLY-8161 for Treatment of Advanced NRAS-Mutant Melanoma and Other Solid Tumors
This is a Phase 1/2 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, colorectal and other solid tumors.
Inclusion: 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: Prior treatment with ERK, MEK, RAF, or RAS targeting agents or any agent whose mechanism of action is to inhibit the RAS-MAPK pathway; Central nervous system (CNS) metastases associated with progressive neurologic symptoms or requiring ongoing corticosteroids to control the CNS disease; Known activating KRAS, HRAS, BRAF, or EGFR mutation or known alterations in other driver oncogenes that are recognized as actionable oncogenic drivers for the participant's specific tumor type; For participants with melanoma: lactate dehydrogenase (LDH) >2×ULN.