RecruitingPhase 1NCT07584226
A First-in-human Study of RLY-8161 in Advanced NRAS-Mutant Solid Tumors
A First-in-human Study of RLY-8161 for Treatment of Advanced NRAS-Mutant Melanoma and Other Solid Tumors
Sponsor
Relay Therapeutics, Inc.
Enrollment
35 participants
Start Date
Mar 9, 2026
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Min Age: 18 Years
Inclusion Criteria5
- 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 Criteria4
- 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.
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Interventions
DRUGRLY-8161
RLY-8161 is an NRAS-selective inhibitor
Locations(6)
View Full Details on ClinicalTrials.gov
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NCT07584226