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

NCT06173349 | Recruiting Phase 1 DMC FDA Drug

• 3 other identifiers: UCDCC#309NCI-2023-10047P30CA093373
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Treatment related adverse events

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

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

Secondary Outcomes (2)

• Tumor response

  At 6 weeks after the last dose of study medication

• Event-free survival

  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

Study Arms (1)

PLZ4-coated paclitaxel loaded micelles (PPM)

EXPERIMENTAL

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.

Drug: PLZ4-coated paclitaxel loaded micelles (PPM)

Interventions

PLZ4-coated paclitaxel loaded micelles (PPM) DRUG

Given PLZ4-coated paclitaxel loaded micelles intravesically

Also known as: Paclitaxel, PPM

PLZ4-coated paclitaxel loaded micelles (PPM)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Davis: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of California Davis Comprehensive Cancer Center

Sacramento, California, 95817, United States

RECRUITING

MeSH Terms

Conditions

Non-Muscle Invasive Bladder Neoplasms; Urinary Bladder Neoplasms

Interventions

Paclitaxel

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Mamta Parikh

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Office of Clinical Research

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2023
• First Posted: December 15, 2023
• Study Start: November 22, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: March 13, 2026

Record last verified: 2026-03

Locations

US (1)