A First-in-human Study of RLY-8161 in Advanced NRAS-Mutant Solid Tumors

About

Brief 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.

Primary Purpose

Treatment

Study Type

Interventional

Phase

Phase 1

Eligibility

Gender

All

Healthy Volunteers

No

Minimum Age

18 Years

Maximum Age

N/A

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.

Not a fit? Find another study