A Phase I Intravesical PPM Therapy for NMIBC

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 2

Trial Details

NCT ID
NCT05519241
Phase
PHASE1
Sponsor
VA Office of Research and Development
Status
RECRUITING
Cancer Type
Bladder Cancer
Interventions
  • PLZ4-coated paclitaxel-loaded micelles (PPM)
Locations (sample)
  • Boston, Massachusetts, United States|42.35843,-71.05977

Key Eligibility Criteria

  • Patients must meet all of the following criteria to be eligible for study entry.
  • Histologically confirmed bladder carcinoma in situ (CIS) urothelial or urothelial carcinoma, with or without T1 cancer. Patients are eligible if th…
  • Patient must have BCG-unresponsive non-muscle-invasive bladder cancer (NMIBC) or intolerance of treatment with BCG. Treatment of pembrolizumab is n…
  • Persistent or recurrent CIS alone or with recurrent Ta/T1 (noninvasive papillary disease/tumor invades the subepithelial connective tissue) disease…

For full eligibility, visit ClinicalTrials.gov.

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