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

This is a Phase 1/2 first-in-human, open-label multicenter study designed to evaluate the safety, tolerability, PK, pharmacodynamics, and preliminary antitumor activity of RLY-8161, an NRAS-selective inhibitor, in participants with advanced NRAS-mutant melanoma, colorectal and other solid tumors. This study consists of 2 parts: dose escalation (Part 1) and dose expansion (Part 2). Part 1, dose escalation will explore multiple ascending doses of RLY-8161 in participants with any advanced NRAS-mutant solid tumor until maximum tolerated dose (MTD) is reached or one or more recommended Phase 2 dose (RP2D) is identified. Part 2, dose expansion will be at the RP2D(s) identified in Part 1 in NRAS-mutant solid tumors.