A Phase 1, Open-Label, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacodynamics and Preliminary Efficacy of Intratumoural Adze1.C in Participants With Metastatic Melanoma
This is Phase I, open label, multi-center clinical trial evaluating an investigational treatment, Adze1.C. Adze1.C is a type of oncolytic virus therapy for adults with advanced Melanoma that have not responded to standard treatments. Oncolytic viruses are designed to infect and destroy cancer cells and have the potential to stimulate the immune system to fight tumors. The purpose of this study is to determine the safety of Adze1.C, how well it is tolerated, and to identify the highest dose that can be safely given.
• Male or female participants aged 18 years or older at Screening.
• Histologically confirmed unresectable Stage IIIB to IV metastatic melanoma.
• Refractory to, or unsuitable for, standard treatment options as determined by the investigator.
• Not a suitable candidate for curative resection.
• Presence of measurable disease per iRECIST (excluding irradiated lesions unless progression post-radiation is documented).
• ECOG performance status of 0 or 1 at Screening.
• Willing and able to provide written informed consent and comply with study procedures.