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A Phase I Intravesical PPM Therapy for NMIBC

NCT05519241 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2025-09-02

No results posted yet for this study

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.

Conditions

  • Non-muscle-invasive Bladder Cancer

Interventions

DRUG

PLZ4-coated paclitaxel-loaded micelles (PPM)

PPM will be administrated weekly for 6 times through intravesical instillation into the bladder cavity

Sponsors & Collaborators

  • University of California, Davis

    collaborator OTHER

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Chong-Xian Pan, MD PhD · VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-10
Primary Completion
2026-08-31
Completion
2026-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05519241 on ClinicalTrials.gov