NCT06173349 PLZ4-Coated Paclitaxel-Loaded Micelles for the Treatment of Patients With Recurrent or Refractory Non-Muscle Invasive Bladder Cancer
| NCT ID | NCT06173349 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | University of California, Davis |
| Condition | Recurrent Non-Muscle Invasive Bladder Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 12 participants |
| Start Date | 2023-11-22 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 12 participants in total. It began in 2023-11-22 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Mamta Parikh
PRINCIPAL INVESTIGATOR
University of California, Davis
Frequently Asked Questions
Who can join the NCT06173349 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Recurrent Non-Muscle Invasive Bladder Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06173349 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06173349 currently recruiting?
Yes, NCT06173349 is actively recruiting participants. Contact the research team at OCRReferral@health.ucdavis.edu for enrollment information.
Where is the NCT06173349 trial being conducted?
This trial is being conducted at Sacramento, United States.
Who is sponsoring the NCT06173349 clinical trial?
NCT06173349 is sponsored by University of California, Davis. The principal investigator is Mamta Parikh at University of California, Davis. The trial plans to enroll 12 participants.