A Phase III Study Evaluating Safety and Effectiveness of Intravesical FL115 Alone or With BCG in Treating Non-Muscle Invasive Bladder Cancer

What this Trial Is About

Researchers are evaluating the safety and tolerability of the drug FL115, given alone or combined with BCG, in patients with non-muscle invasive bladder cancer NMIBC. The study aims to find the recommended phase 2 dose RP2D of FL115 with BCG and to explore its preliminary effectiveness. The trial includes three parts FL115 alone dose escalation, FL115 with BCG dose escalation, and a cohort expansion of FL115 with BCG treatment. Participants receive FL115 intravesically either alone or with BCG through three treatment periods induction, enhanced induction or maintenance 1, and maintenance 2. These treatment schedules are designed to assess the drug doses and combination effects systematically. The study involves dose escalation phases followed by a cohort expansion phase to further evaluate safety and anti-tumor activity. Individuals in the study will be closely monitored with safety and tolerability assessments up to 5 years, and primary outcomes include maximum tolerated dose MTD, RP2D, complete response at 36 months, and disease-free rate at 12 months. Participants undergo required procedures and follow-ups to assess drug effects and health status. The study aims to provide thorough data on FL115s safety and potential anti-cancer activity over several years.

A Study of Intravesical FL115 Alone or in Combination With BCG in Non-Muscle Invasive Bladder Cancer