Study of NDV01 KIT Treatment for Adults With High Grade Non-Muscle Invasive Bladder Cancer

What this Trial Is About

Researchers are evaluating the safety and effectiveness of NDV01 KIT, a combination of gemcitabine HCl and docetaxel, given directly into the bladder for patients with high-grade Non-Muscle Invasive Bladder Cancer NMIBC. This prospective, single-arm Phase 2 study aims to assess how well this treatment works and its safety profile, including measuring complete response rates and monitoring adverse events over 48 weeks. A pharmacokinetic sub-study will also examine systemic exposure to the drugs. Participants will receive NDV01 KIT through a catheter directly into the bladder. The treatment includes six biweekly instillations on Days 1, 14, 28, 42, 56, and 70, followed by a Primary Disease Evaluation around Day 100. Patients who achieve a complete response may continue with monthly maintenance treatments up to Month 12, with doses on Days 107, 140, 187, 220, 250, 287, 310, and 340. Those who do not reach complete response at evaluation will receive a second round of six biweekly treatments followed by maintenance per protocol. During the study, participants will undergo disease evaluations, blood draws for pharmacokinetic analysis, and regular monitoring for safety and treatment effects. Researchers will track complete response durability, event-free survival, incidence of cystectomy, and overall survival. The total duration of participation may extend through the treatment and maintenance phases, with assessments scheduled at defined intervals to monitor response and safety.

Open Label Study to Evaluate the Safety and Efficacy of NDV01 KIT in High Grade NMIBC