NCT05710848

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

A Phase 1/2a Study of STM-416 Administered Intraoperatively to Patients Undergoing Transurethral Resection of Bladder Tumor (TURBT) for Recurrent High-Grade Papillary Bladder Cancer

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 75 (estimated)
• Sponsor: SURGE Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a first-in-human (FIH), Phase 1/2a, multi center, open-label, single treatment, dose escalation and expansion study designed to determine the safety and tolerability of STM-416 in patients with bladder cancer.

Detailed description

This is a 2-part, multicenter, first-in-human (FIH), Phase 1/2a study in patients with a history of pathologically confirmed high-grade Ta or T1 NMIBC without CIS who have completed SOC previously, with recurrent papillary disease seen on cystoscopy, and who are undergoing TURBT without perioperative intravesical chemotherapy. All patients will receive relevant SOC therapy following TURBT. SOC will be administered in the adjuvant setting. Phase 1 is an open-label, single-treatment, dose-escalation study to evaluate the safety and tolerability of up to 6 increasing doses of intraoperatively administered STM-416 utilizing a 3+3 convention, with 3 to 6 patients enrolled in each STM-416 dose level, with a minimum of 6 patients enrolled at the highest dose level, for a total of approximately 30 patients. Phase 2a is a randomized, single-blind, single-treatment, dose-expansion study that will comprise 2 arms: TURBT + STM-416 Dose 1 followed by SOC versus TURBT + STM-416 Dose 2 followed by SOC.

Conditions

• Non-muscle-invasive Bladder Cancer

Interventions

Type	Name	Description
DRUG	STM-416	STM-416 monotherapy

Timeline

• Start date: 2023-07-11
• Primary completion: 2026-05-01
• Completion: 2026-08-01
• First posted: 2023-02-02
• Last updated: 2026-02-19

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study