NCT06173349

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

A Phase I Microtrial With PLZ4-Coated Paclitaxel-Loaded Micelles (PPM) in Patients With Recurrent or Refractory Non-Myoinvasive Bladder Cancer

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: University of California, Davis · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVE: I. Evaluate the safety and tolerability of PPM administered through intravesical instillation. SECONDARY OBJECTIVES: I. Evaluate tumor response at 6 weeks after completion of PPM intravesical therapy. II. Assess event-free survival rate at 12 months. OUTLINE: Patients receive PPM intravesically over 1 hour once a week (QW) for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo computed tomography (CT), magnetic resonance imaging (MRI), or positron emission tomography (PET), and cystoscopy with biopsy at screening and follow up and undergo collection of blood samples throughout the trial. After completion of study treatment, patients are followed up at 3 weeks, 6 weeks, and then every 3 months per standard of care for 2 years.

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

Type	Name	Description
DRUG	PLZ4-coated paclitaxel loaded micelles (PPM)	Given PLZ4-coated paclitaxel loaded micelles intravesically

Timeline

• Start date: 2023-11-22
• Primary completion: 2026-12-01
• Completion: 2027-06-01
• First posted: 2023-12-15
• Last updated: 2026-03-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study