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A First-in-human Study of RLY-8161 in Advanced NRAS-Mutant Solid Tumors
Trial Status: active
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.
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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07584226.
