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PLZ4-Coated Paclitaxel-Loaded Micelles for the Treatment of Patients With Recurrent or Refractory Non-Muscle Invasive Bladder Cancer

NCT06173349 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2026-03-13

No results posted yet for this study

Summary

This phase I trial tests the safety, tolerability and effectiveness of PLZ4-coated paclitacel-loaded micelles (PPM) in treating patients with non-muscle invasive bladder cancer that has come back after a period of improvement (recurrent) or that does not respond to treatment (refractory). PPM is a bladder cancer-specific nanoparticle that can specifically target and deliver treatment to the tumor cells in the bladder. PPM contains paclitaxel, which is a drug that kills tumor cells or keeps them from growing.

Conditions

  • Recurrent Non-Muscle Invasive Bladder Carcinoma
  • Stage 0a Bladder Cancer AJCC v8
  • Stage 0is Bladder Cancer AJCC v8
  • Stage I Bladder Cancer AJCC v8

Interventions

DRUG

PLZ4-coated paclitaxel loaded micelles (PPM)

Given PLZ4-coated paclitaxel loaded micelles intravesically

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • University of California, Davis

    lead OTHER

Principal Investigators

  • Mamta Parikh · University of California, Davis

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-22
Primary Completion
2026-12-31
Completion
2027-06-30
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 NCT06173349 on ClinicalTrials.gov