Phase 12a Study of STM-416 Given During Bladder Tumor Removal Surgery for Patients with Recurrent High-Grade Non-Muscle-Invasive Bladder Cancer

What this Trial Is About

Researchers are evaluating STM-416, a drug studied for safety and tolerability in patients with recurrent high-grade papillary non-muscle-invasive bladder cancer NMIBC without carcinoma in situ CIS. This first-in-human, Phase 12a, multi-center study includes patients who have completed standard of care SOC and have visible recurrent disease, focusing on those undergoing transurethral resection of bladder tumor TURBT without perioperative intravesical chemotherapy. The study aims to determine the safety of STM-416 administered during surgery and to explore its effects alongside SOC therapy given afterward. The study has two parts. Phase 1 is an open-label, dose-escalation phase where up to six increasing doses of STM-416 are given intraoperatively in 3 to 6 patients per dose to assess safety and tolerability. Phase 2a is a randomized, single-blind, dose-expansion phase comparing two doses of STM-416 administered during TURBT followed by SOC therapy. All participants receive SOC treatment after surgery. The study plans to enroll about 30 patients in Phase 1, with additional participants in Phase 2a. Participants will undergo TURBT surgery with STM-416 treatment during the procedure, followed by SOC therapy. Researchers will monitor dose-limiting toxicities and adverse events for up to 90 days in Phase 1 and track recurrence-free survival for up to 24 months in Phase 2a. Pharmacokinetics and pharmacodynamics of STM-416 will be studied at various time points after administration. Overall, participants will be followed regularly to assess safety, treatment response, and disease recurrence as part of the study lasting up to two years.

A Study of STM-416 Administered to Patients Undergoing TURBT for Recurrent Bladder Cancer