OncoMatch/Clinical Trials/NCT05519241
A Phase I Intravesical PPM Therapy for NMIBC
Is NCT05519241 recruiting? Yes, currently enrolling (Sep 2026). This Phase 1 trial studies PLZ4-coated paclitaxel-loaded micelles (PPM) for non-muscle-invasive bladder cancer.
Treatment: PLZ4-coated paclitaxel-loaded micelles (PPM) — 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 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Chemotherapy
Cancer type
Urothelial Carcinoma
Disease stage
Required: Stage CIS (other)
carcinoma in situ (CIS) urothelial or urothelial carcinoma, with or without T1 cancer
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: BCG — non-muscle-invasive bladder cancer
Patient must have BCG-unresponsive non-muscle-invasive bladder cancer (NMIBC) or intolerance of treatment with BCG
Lab requirements
Blood counts
Absolute neutrophil count (AGC/ANC) ≥ 1,500/uL; Platelets ≥ 100,000/uL; Hemoglobin ≥ 8 g/dL
Kidney function
Calculated glomerular filtration rate (GFR) ≥ 50 mL/min/1.73m2
Liver function
Total bilirubin ≤ 2.0 x ULN (< 3 x ULN for patients with Gilbert's syndrome); AST, ALT, ALP ≤ 3.0 x ULN
Cardiac function
No NYHA Class III or IV heart failure, uncontrollable supraventricular arrhythmias, any history of a ventricular arrhythmia, or other clinical signs of severe cardiac dysfunction; No symptomatic congestive heart failure (CHF), severe/unstable angina pectoris, or myocardial infarction within 6 months prior to study entry
Laboratory tests performed within 14 days of study enrollment: AGC/ANC ≥ 1,500/uL; Platelets ≥ 100,000/uL; Hemoglobin ≥ 8 g/dL; Calculated GFR ≥ 50 mL/min/1.73m2; Total bilirubin ≤ 2.0 x ULN (< 3 x ULN for patients with Gilbert's syndrome); AST, ALT, ALP ≤ 3.0 x ULN. Adequate pulmonary function with no clinical signs of severe pulmonary dysfunction. No NYHA Class III or IV heart failure, uncontrollable supraventricular arrhythmias, any history of a ventricular arrhythmia, or other clinical signs of severe cardiac dysfunction; No symptomatic congestive heart failure (CHF), severe/unstable angina pectoris, or myocardial infarction within 6 months prior to study entry
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA · Boston, Massachusetts
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05519241 currently recruiting?
Yes, this trial is currently recruiting patients.
Is prior treatment required for enrollment?
Yes. Patients must have previously received BCG.
What disease stage is eligible?
Stage CIS is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages