Tiny Drug-Carrying particles aim to blast bladder cancer cells
NCT ID NCT05519241
First seen Jun 26, 2026 · Last updated Aug 18, 2026 · Updated 2 times
Summary
This early-stage trial tests a new drug called PPM, which are tiny particles loaded with the chemotherapy drug paclitaxel and coated with a molecule (PLZ4) that helps them target bladder cancer cells. The drug is given directly into the bladder through a catheter once a week for six weeks. The study includes up to 29 people with non-muscle-invasive bladder cancer that has not responded to the standard BCG treatment. The main goals are to find the safest dose and to get an early look at whether the drug can shrink or eliminate the cancer.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- PLZ4-coated paclitaxel-loaded micelles (PPM)
- What this could lead to
- If it works, this could lead to a new treatment option for bladder cancer that hasn't responded to standard therapy, potentially avoiding more invasive surgery.
- What could go wrong
- This is a very early Phase 1 trial with only 29 participants, so the main goal is safety and dosing, not proof of effectiveness. The drug may not work or could have unexpected side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 29 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2022
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a US federal agency other than the NIH.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Patients must meet all of the following criteria to be eligible for study entry. * Histologically confirmed bladder carcinoma in situ (CIS) urothelial or urothelial carcinoma, with or without T1 cancer. Patients are eligible if the biopsy was done within 3 months of enrollment and a cystoscopy demonstrates no gross disease invasion into muscularis propria within 4 weeks of enrollment. * Patient must have BCG-unresponsive non-muscle-invasive bladder cancer (NMIBC) or intolerance of treatment with BCG. Treatment of pembrolizumab is not an inclusion or exclusion criteria as intravesical taxane probably has comparable efficacy as intravenous pembrolizumab. 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 6 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 urologic guidelines * Performance status: ECOG performance status of 0, 1, or 2 or Karnofsky performance status of 50 or higher * Patient with life expectancy greater than 24 months * No concurrent radiotherapy, chemotherapy, or other immunotherapy * 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 participating urologist * Laboratory tests performed within 14 days of study enrollment: * Absolute neutrophil count (AGC/ANC)1,500/uL * Platelets100,000/uL \[Patients may be transfused to meet this requirement\] * Hemoglobin 8 g/dL \[Patients may be transfused to meet this requirement\] * Calculated glomerular filtration rate (GFR) 50 mL/min/1.73m2 * Total bilirubin 2.0 X ULN (\< 3 x ULN for patients with Gilbert's syndrome) * AST, ALT, ALP 3.0 X ULN * Adequate pulmonary function with no clinical signs of severe pulmonary dysfunction * Negative serum pregnancy test if the study participant is a female and of childbearing potential (non-childbearing is defined as greater than one year postmenopausal or surgically sterilized) * Female participants of childbearing potential must adhere to using a medically accepted method of birth control, i.e. a tubal ligation, an approved hormonal contraceptive or an intrauterine device, prior to screening and agree to continue its use during the study and up to 3 months after finishing this study or be surgically sterilized (e.g., hysterectomy or tubal ligation). Males must agree to use barrier methods of birth control while on study * Provide signed informed consent and HIPAA authorization and agree to comply with all protocol-specified procedures and follow-up evaluations Exclusion Criteria: Patients who meet any of the following criteria will be excluded from study entry. * 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 (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 anti-inflammatory 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 nursing * Psychiatric illness/social situations that would limit compliance with study requirements * Other illness that in the opinion of the investigator would exclude the patient from participating in this study * Any other malignancy diagnosed within 3 years of trial entry with the exception of: * 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. * Patients unwilling to or unable to comply with the protocol * Patients with impaired decision-making capacity
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
RECRUITINGBoston, Massachusetts, 02130-4817, United States
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Other studies related to the condition(s) this trial covers.
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- Can intensified chemotherapy before surgery clear bladder tumors?
- Lab-Grown tumor organoids could pick the right bladder chemo
- Chemo combo tested as backup for bladder cancer that outsmarts First-Line therapy
- Chemo gel delivered directly to kidney tumors: can it help when other options run out?