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NCT05519241 · ClinicalTrials.gov record · last posted 2026-08-17

A Phase I Intravesical PPM Therapy for NMIBC

StatusRecruiting
PhasePhase 1
Started2022-10-10
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from the ClinicalTrials.gov record
This clinical trial is to determine the safety and effectiveness of an investigational bladder cancer drug named "PLZ4-coated paclitaxel-loaded nanoscale micelle (PPM)." PPM is tiny particles that contain the chemotherapy drug paclitaxel. PLZ4 is a molecule that can possibly guide PPM to specifically target and deliver paclitaxel into and kill bladder cancer cells. In this trial, PPM will be instilled into the bladder cavity to treat bladder cancer that does not invade into the muscle layer of the bladder and that has failed the treatment of another drug Bacillus Calmette-Guérin (BCG). Up to 29 patients will be enrolled into the trial. The main goal of this trial is to determine the dose of PPM for future clinical trials, assess the toxicity and obtain preliminary data regarding its effectiveness.

Protocol amendment history 2 changes detected by DataLookout

2026-08-18
Primary completion pushed: 2026-08-31 → 2027-08-31
2026-08-18
Completion pushed: 2026-08-31 → 2027-12-31
Trial Details
NCT Number NCT05519241
Lead Sponsor VA Office of Research and Development
Collaborators: University of California, Davis
Conditions Non-muscle-invasive Bladder Cancer
Enrollment 29 participants
Start Date 2022-10-10
Primary Completion 2027-08-31 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-08-17