Phase 2a Trial of SYNC-T Therapy SV-102 Evaluating Safety, Dose, and Effectiveness in Men with Advanced Metastatic Castration-Resistant Prostate Cancer

What this Trial Is About

Researchers are evaluating SYNC-T Therapy SV-102 in men with advanced metastatic castration-resistant prostate cancer. This Phase 2a study aims to assess the safety, tolerability, and effectiveness of this treatment, while identifying the maximum tolerated dose and the optimal dose for further studies. The trial focuses on men whose cancer has progressed despite prior therapies, including androgen-receptor-pathway inhibitors and taxane chemotherapy. Participants will receive partial tumor destruction through cryolysis followed by an intratumoral infusion of SV-102. The study features a dose escalation phase with three different dose levels, followed by a dose optimization phase where participants receive doses selected from the initial phase. All participants receive partial oncolysis combined with SV-102 infused directly into tumor lesions that meet specific size and accessibility criteria. During the study, participants will be monitored closely with assessments of adverse events, dose tolerability, tumor response, and survival outcomes for up to two years. Regular laboratory tests, imaging scans, and tumor biopsies will be performed to measure drug levels, immune reactions, and disease progression. The study also tracks detailed pharmacokinetic parameters and safety signals to evaluate the therapys effects and optimal dosing over time.

A Study of SYNC-T Therapy SV-102 in Participants With Metastatic Castration-Resistant Prostate Cancer