Overview

A Phase I Intravesical PPM Therapy for NMIBC

Status:
Not yet recruiting
Trial end date:
2026-08-31
Target enrollment:
Participant gender:
Summary
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 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.
Phase:
Phase 1
Details
Lead Sponsor:
VA Office of Research and Development
Collaborator:
University of California, Davis
Treatments:
Paclitaxel