Actively Recruiting
A First-in-human Study of RLY-8161 in Advanced NRAS-Mutant Solid Tumors
Led by Relay Therapeutics, Inc. · Updated on 2026-05-13
35
Participants Needed
4
Research Sites
199 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A First-in-human Study of RLY-8161 in Advanced NRAS-Mutant Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- Histologically confirmed unresectable Stage III or IV melanoma or other solid tumor
- Disease is refractory to standard therapy, intolerant of standard therapy, or participant has declined standard therapy
- Measurable disease per RECIST v1.1 criteria
- One or more documented primary oncogenic NRAS mutation(s)
You will not qualify if you...
- Known activating KRAS, HRAS, or BRAF mutation or other driver oncogene alterations
- Prior treatment with ERK, MEK, RAF, or RAS targeting agents or any agent inhibiting the RAS-MAPK pathway
- For melanoma participants: lactate dehydrogenase (LDH) greater than 2 times the upper limit of normal
- Central nervous system metastases with progressive neurologic symptoms or requiring ongoing corticosteroids
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
2
START Midwest, LLC
Grand Rapids, Michigan, United States, 49546
Actively Recruiting
3
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
4
NEXT Virginia
Fairfax, Virginia, United States, 22031
Actively Recruiting
Research Team
R
Relay Therapeutics, Inc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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