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The study aims to determine the MTD and/or RP2D of RLY-8161 in Part 1. Part 2 of the study will further evaluate the safety and efficacy of 1 or more RP2Ds of RLY-8161 identified in Part 1.

Who can Participate

Inclusion: -Histologically confirmed diagnosis of unresectable Stage III or IV melanoma or other solid tumor -One or more documented primary oncogenic NRAS mutation(s) in blood and/or tumor per local assessment -Must be relapsed and/or refractory or intolerant to at least 1, but no more than 2, prior lines of ICI therapy in any setting and no prior cytotoxic chemotherapy or TIL therapy (e.g., lifileucel) in the advanced/metastatic setting. Exclusion: -Known activating KRAS, HRAS, or BRAF mutation resulting in oncogenic pathway activation downstream to RAS pathway or known alterations in other driver oncogenes (e.g., EGFR, ALK, RET) based on local assessment. -Prior treatment with ERK, MEK, RAF, or RAS targeting agents or any agent whose mechanism of action is to inhibit the RAS-MAPK pathway. More details about who can and cannot join are on ClinicalTrials.gov. Your study doctor or study team member will review these requirements with you.

Study ID

More information available at ClinicalTrials.gov: NCT07584226