Recruiting
Phase 1

PLZ4-Coated Paclitaxel

Sponsor:

UCLA

Code:

NCT06173349

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

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

PLZ4-coated paclitaxel loaded micelles (PPM)

Study Details

Brief 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.

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

Study ID

NCT06173349

Start date

Nov 22, 2023

Status verified date

Mar, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Histologically confirmed non muscle invasive bladder cancer (NMIBC), defined as noninvasive papillary carcinoma (Ta), carcinoma in situ (CIS) or carcinoma invading the subepithelial connective tissue (T1), determined via transurethral resection of bladder tumor (TURBT) within 3 months of enrollment
  • 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 (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 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
  • Refuse or intolerant of a radical cystectomy recommended by the treating urologist as the standard next therapy per American Urological Association (AUA) guideline
  • Age ≥ 18 years at time of consent
  • Performance status: Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
  • Patient with life expectancy greater than 24 months
  • No concurrent radiotherapy, chemotherapy, or other immunotherapy for bladder cancer. No BCG or other intravesical treatment within 4 weeks
  • No scheduled radiotherapy, chemotherapy, other immunotherapy, or surgery before the scheduled response evaluation
  • Recovery from prior treatment side effects that might interfere with the study treatment, in the judgment of the investigator
  • Absolute neutrophil count (absolute granulocyte count \[AGC\]/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
  • Adequate pulmonary function by clinical assessment with no clinical signs of severe pulmonary dysfunction
  • Participants of childbearing potential must agree to using adequate contraception (e.g., hormonal or barrier method of birth control; abstinence, an intrauterine device) for the duration of study participation (including dosing interruptions) and up to 3 months after last study treatment; or be surgically sterilized (e.g., hysterectomy, tubal ligation, or vasectomy)
  • Ability to understand and willingness to sign an informed consent form
  • Ability and willingness to adhere to the study visit schedule and other protocol requirements

Exclusion Criteria:

  • Existence of cancer at the upper urinary tract
  • Concurrent use of other investigational agents
  • Evidence of regional and/or distant metastasis
  • NYHA (New York Heart Association) class III or IV heart failure, 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
  • Patient has an intractable bleeding disorder (e.g., coagulation factors deficiencies, Von Willebrand Disease)
  • Patient taking medications that affect coagulation, such as aspirin (though, aspirin 81 mg oral once daily is allowed), Coumadin/Warfarin, heparin, low molecular weight heparin, direct thrombin inhibitors, and direct factor Xa inhibitors. Other nonsteroidal antiinflammatory drugs (NSAIDs) are allowed as long as they are discontinued the day before therapy
  • History or evidence of uncontrollable central nervous system (CNS) disease
  • Active systemic infection requiring parenteral antibiotic therapy
  • Women who are pregnant or breast feeding
  • Any other malignancy diagnosed within 3 years of trial entry with the exception of the following:

  • Basal or squamous cell skin cancers, or
  • Noninvasive cancer of the cervix, or
  • Any other cancer deemed to be of low-risk for progression or patient morbidity during trial period, such as localized prostate cancer after definitive treatment and prostate-specific antigen (PSA) less than 0.2 ng/mL
  • Any condition that would prohibit the understanding or rendering of informed consent
  • Any condition that in the opinion of the investigator would interfere with the participant's safety or compliance while on trial

Study Design

Enrollment

12 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: PLZ4-coated paclitaxel loaded micelles (PPM)

Patients receive PPM intravesically over 1 hour QW for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, MRI, or PET, and cystoscopy with biopsy at screening and follow up and undergo collection of blood samples throughout the trial.

Interventions

PLZ4-coated paclitaxel loaded micelles (PPM)

Given PLZ4-coated paclitaxel loaded micelles intravesically

Primary outcome measure

  • Treatment related adverse events [ Time Frame: From first dose of study medication through 12 months after the last dose ]

Central Contacts and Locations

Central contacts

Office of Clinical Research

916-382-6970OCRReferral@health.ucdavis.edu

Locations

University of California Davis Comprehensive Cancer Center

Recruiting

Sacramento, California, United States, 95817

Contacts

Office of Clinical research

916-382-6970OCRReferral@health.ucdavis.edu

Principal Investigator:

Mamta Parikh, MD

More Information

Sponsor

University of California, Davis

Last update posted

Mar 13, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, Davis on 2026-03-13.