Phase 1 Study of Intratumoral Adze1.C Treatment for Adults With Metastatic Melanoma Not Responding to Standard Therapies

What this Trial Is About

Researchers are evaluating Adze1.C, an investigational oncolytic virus therapy, in adults with advanced metastatic melanoma that has not responded to standard treatments. This Phase 1, open-label, multicenter trial aims to assess the safety, tolerability, and preliminary effectiveness of Adze1.C and to determine the highest dose that can be safely administered. The study uses a stepwise dose-escalation design to carefully evaluate treatment effects and side effects. Participants receive Adze1.C by direct injection into their tumors. All start with a low initial dose followed three weeks later by a higher dose depending on their assigned dose group 100 million, 1 billion, or 10 billion viral particles. Injections are given every two weeks, and participants may continue treatment for up to 14 weeks if eligible. The trial enrolls up to 30 participants across three sequential dose groups. During the study, participants are closely monitored for side effects, with safety evaluations focusing on a 5-week period after starting treatment. Researchers assess treatment-emergent adverse events, dose-limiting toxicities, and viral shedding in bodily fluids. They also measure tumor response, progression-free survival, and quality of life. The total treatment and observation period includes follow-up visits through Week 16. The trial is sponsored by Adze Biotechnology Australia Pty Ltd.

A Study to Evaluate Adze1.C in Participants With Metastatic Melanoma