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 (May 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
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
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