OncoMatch/Clinical Trials/NCT05519241
A Phase I Intravesical PPM Therapy for NMIBC
Is NCT05519241 recruiting? Yes, currently enrolling (May 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 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
Cancer type
Urothelial Carcinoma
Disease stage
Required: Stage CIS
Grade: high-grade (for Ta/T1 disease)
Persistent or recurrent CIS alone or with recurrent Ta/T1 (noninvasive papillary disease/tumor invades the subepithelial connective tissue) disease within 12 months of completion of adequate BCG therapy; Recurrent high-grade Ta/T1 disease within 6 months of completion of adequate BCG therapy; T1 high-grade disease at the first evaluation following an induction BCG course
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: BCG therapy — non-muscle-invasive bladder cancer
BCG-unresponsive non-muscle-invasive bladder cancer (NMIBC) or intolerance of treatment with BCG
Lab requirements
Blood counts
AGC/ANC ≥ 1,500/uL; Platelets ≥ 100,000/uL (may be transfused); Hemoglobin ≥ 8 g/dL (may be transfused)
Kidney function
Calculated 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 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 [Patients may be transfused to meet this requirement]; Hemoglobin 8 g/dL [Patients may be transfused to meet this requirement]; 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. NYHA (New York Heart Association) Class III or IV heart failure (Appendix C), uncontrollable supraventricular arrhythmias, any history of a ventricular arrhythmia, or other clinical signs of severe cardiac dysfunction. 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
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