Clinical Trial

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

Study acronym: HGNMIBC
Recruiting Phase 2
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Record status
This record was last updated June 13, 2025 (before its estimated August 2025 completion). Its status may not reflect the trial's current state.
Summary
This is a prospective, single-arm study evaluating the safety and efficacy of NDV01 KIT, a fixed-dose combination of gemcitabine HCl and docetaxel, administered via intravesical instillation in patients with high-grade Non-Muscle Invasive Bladder Cancer (NMIBC). NDV01 KIT includes 60 mL Carbopol Gel followed by 15 g NDV01 solution (gemcitabine HCl 1000 mg and docetaxel 40 mg), administered biweekly for six treatments, followed by monthly maintenance therapy for up to 12 months. The study includes a pharmacokinetic (PK) sub-study assessing systemic exposure to NDV01's active ingredients.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-10-28.
Trial Details
NCT Number NCT06663137
Lead Sponsor Relmada Therapeutics, Inc.
Conditions Non Muscle Invasive Bladder Cancer
Enrollment 70 participants
Start Date 2024-08-01
Primary Completion 2025-08 (estimated)
Study Completion 2026-08 (estimated)
Updated on ClinicalTrials.gov 2025-06-13