OncoMatch/Clinical Trials/NCT06173349
PLZ4-Coated Paclitaxel-Loaded Micelles for the Treatment of Patients With Recurrent or Refractory Non-Muscle Invasive Bladder Cancer
Is NCT06173349 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1 trial studies PLZ4-coated paclitaxel loaded micelles (PPM) for recurrent non-muscle invasive bladder carcinoma.
Treatment: PLZ4-coated paclitaxel loaded micelles (PPM) — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Chemotherapy
Cancer type
Urothelial Carcinoma
Disease stage
Required: Stage CIS (AJCC v8)
noninvasive papillary carcinoma (Ta), carcinoma in situ (CIS) or carcinoma invading the subepithelial connective tissue (T1)
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: Bacillus Calmette Guerin (BCG) therapy — intravesical
Participant must have Bacillus Calmette Guerin (BCG)-unresponsive NMIBC or intolerance of treatment with BCG. BCG-unresponsive disease is defined as being at least one of the following: Persistent or recurrent CIS alone or with recurrent Ta/T1 disease within 12 months of completion of adequate BCG therapy; Recurrent high-grade Ta/T1 disease within 12 months of completion of adequate BCG therapy; T1 high-grade disease at the first evaluation following an induction BCG course. In this context, adequate BCG therapy is defined as at least one of the following: At least five of six doses of an initial induction course plus at least two of three doses of maintenance therapy; At least five of six doses of an initial induction course plus at least two of six doses of a second induction course
Cannot have received: concurrent radiotherapy, chemotherapy, or other immunotherapy for bladder cancer
No concurrent radiotherapy, chemotherapy, or other immunotherapy for bladder cancer. No BCG or other intravesical treatment within 4 weeks
Lab requirements
Blood counts
Absolute neutrophil count (ANC) ≥ 1,500/µL; Platelets ≥ 100,000/µL (patients may be transfused to meet this requirement); Hemoglobin ≥ 8 g/dL (patients may be transfused to meet this requirement)
Kidney function
Calculated glomerular filtration rate (GFR) ≥ 30 mL/min
Liver function
Total bilirubin ≤ 2.0 × institutional upper limit of normal (ULN) (< 3 × ULN for patients with Gilbert's syndrome); AST, ALT, ALP ≤ 3.0 × institutional ULN
Absolute neutrophil count (ANC) ≥ 1,500/µL; Platelets ≥ 100,000/µL (Patients may be transfused to meet this requirement); Hemoglobin ≥ 8 g/dL (Patients may be transfused to meet this requirement); Calculated glomerular filtration rate (GFR) ≥ 30 mL/min; Total bilirubin ≤ 2.0 × institutional upper limit of normal (ULN) (< 3 × ULN for patients with Gilbert's syndrome); Aspartate transaminase (AST), alanine transaminase (ALT), alkaline phosphatase (ALP) ≤ 3.0 × institutional ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of California Davis Comprehensive Cancer Center · Sacramento, California
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06173349 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior concurrent radiotherapy, chemotherapy, or other immunotherapy for bladder cancer disqualifies patients from enrollment.
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