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Recurrent Non-Muscle Invasive Bladder CarcinomaPhase 1NCT06173349

PLZ4-Coated Paclitaxel-Loaded Micelles for the Treatment of Patients With Recurrent or Refractory Non-Muscle Invasive Bladder Cancer

A Phase 1 study testing PLZ4-coated paclitaxel loaded micelles (PPM) in people with Recurrent Non-Muscle Invasive Bladder Carcinoma and Stage 0a Bladder Cancer AJCC v8, run by University of California, Davis at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
PLZ4-coated paclitaxel loaded micelles (PPM)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteUnited States
Study dates
22 Nov 2023to Jun 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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)
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  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Office of Clinical Research contact

916-382-6970

OCRReferral@health.ucdavis.edu

United States1 site, 1 recruiting

  • University of California Davis Comprehensive Cancer Center

    Sacramento, California, 95817

    Office of Clinical research, 916-382-6970, OCRReferral@health.ucdavis.edu

    Mamta Parikh, MD

    Recruiting

Other trials in United States

About this study

Official title: A Phase I Microtrial With PLZ4-Coated Paclitaxel-Loaded Micelles (PPM) in Patients With Recurrent or Refractory Non-Myoinvasive Bladder Cancer

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. Evaluate the safety and tolerability of PPM administered through intravesical instillation.

SECONDARY OBJECTIVES:

  1. Evaluate tumor response at 6 weeks after completion of PPM intravesical therapy.

II. Assess event-free survival rate at 12 months.

OUTLINE:

Patients receive PPM intravesically over 1 hour once a week (QW) for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo computed tomography (CT), magnetic resonance imaging (MRI), or positron emission tomography (PET), and cystoscopy with biopsy at screening and follow up and undergo collection of blood samples throughout the trial.

After completion of study treatment, patients are followed up at 3 weeks, 6 weeks, and then every 3 months per standard of care for 2 years.

Being tested
PLZ4-coated paclitaxel loaded micelles (PPM)
Medical subject headings
Non-Muscle Invasive Bladder Neoplasms, Urinary Bladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PLZ4-coated paclitaxel loaded micelles (PPM)Drug

    Also called Paclitaxel, PPM

    Given PLZ4-coated paclitaxel loaded micelles intravesically

Study groups in NCT06173349
Study groupRoleWhat they receive
PLZ4-coated paclitaxel loaded micelles (PPM)ExperimentalPatients 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.
Receives: Drug: PLZ4-coated paclitaxel loaded micelles (PPM)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Treatment related adverse events

    Number of participants experiencing treatment-related AEs, classified by severity and graded according to the NCI CTCAE v5.0

    Measured: From first dose of study medication through 12 months after the last dose

Secondary outcomes (2)

  1. Tumor response

    Assessment of response will be based on visual evaluation (cystoscopy), biopsy of remaining lesion (where technically feasible) and urine cytology.

    Measured: At 6 weeks after the last dose of study medication

  2. Event-free survival

    Measured: From first dose of study medication to first documentation of objective tumor progression, disease recurrence, bladder resection or irradiation, other anti-bladder cancer therapy, or to death due to disease progression, assessed at 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Dec 2023
  2. Study start22 Nov 2023
  3. Primary completionDec 2026 (estimated)
  4. Study completionJun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06173349
Sponsor's protocol ID
UCDCC#309
Other IDs
NCI-2023-10047, UCDCC#309, P30CA093373
Status last verified
Mar 2026
First submitted
7 Dec 2023
Last updated
13 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Narayan A, Leibrandt RC, Lee JS, Dall'Era MA, Whitson JM, Chandrasekar T, Braun A, Mossanen M, Li H, Lara PN Jr, Lam KS, Pan CX, Parikh M. A Phase I trial of PLZ4-coated paclitaxel-loaded micelles in patients with refractory non-muscle-invasive bladder cancer. Nanomedicine (Lond). 2026 Jun;21(12):1707-1712. doi: 10.1080/17435889.2026.2674162. Epub 2026 Jun 1.

    PubMed 42226594

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PLZ4-coated paclitaxel loaded micelles (PPM) in people with Recurrent Non-Muscle Invasive Bladder Carcinoma and Stage 0a Bladder Cancer AJCC v8, run by University of California, Davis at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 24 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Office of Clinical Research (916-382-6970, OCRReferral@health.ucdavis.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment related adverse events (time frame: From first dose of study medication through 12 months after the last dose). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06173349, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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