Langwarrin

Researchers are evaluating the safety and feasibility of Belzupacap Sarotalocan (AU-011) treatment for bladder cancer, specifically urothelial carcinoma. This phase 1 open-label trial aims to test AU-011 with or without laser application, focusing on minimizing disruption to patients' standard care. The study targets participants with non-muscle invasive bladder cancer (NMIBC) and urothelial carcinoma to assess initial safety and technical aspects of the treatment. The study involves administering AU-011 directly into the tumor (intratumorally) and into the bladder wall (intramurally), either alone or combined with medical laser treatment. Different cohorts receive variations of these treatments to evaluate feasibility and safety. The trial procedures are designed to integrate smoothly with standard care practices, allowing researchers to observe effects with minimal interference in usual treatments. Participants will be closely monitored for safety outcomes, including serious adverse events and dose-limiting toxicities, for up to 12 months. Assessments include clinical evaluations, laboratory tests, and monitoring for any side effects or complications related to the treatment. The study's total duration includes treatment and follow-up periods to thoroughly evaluate participant safety and response to AU-011 therapy.