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NCT05519241
A Phase I Intravesical PPM Therapy for NMIBC
Phase 1 trial testing PLZ4-coated paclitaxel-loaded micelles (PPM) in Non-muscle-invasive Bladder Cancer in 29 participants. Currently enrolling.
31 August 2026
Quick facts
| Lead sponsor | VA Office of Research and Development |
|---|---|
| Phase | Phase 1 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 29 |
| Start date | 10 October 2022 |
| Primary completion | 31 August 2026 |
| Estimated completion | 31 August 2026 |
| Sites | 1 location across United States |
Drugs / interventions tested
- PLZ4-coated paclitaxel-loaded micelles (PPM)
Conditions studied
- Non-muscle-invasive Bladder Cancer — all drugs for Non-muscle-invasive Bladder Cancer →
Sponsor
VA Office of Research and Development — full company profile →
Who can join
18 and older, any sex, with Non-muscle-invasive Bladder Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This clinical trial is to determine the safety and effectiveness of an investigational bladder cancer drug named "PLZ4-coated paclitaxel-loaded nanoscale micelle (PPM)." PPM is tiny particles that contain the chemotherapy drug paclitaxel. PLZ4 is a molecule that can possibly guide PPM to specifically target and deliver paclitaxel into and kill bladder cancer cells. In this trial, PPM will be instilled into the bladder cavity to treat bladder cancer that does not invade into the muscle layer of the bladder and that has failed the treatment of another drug BCG. Up to 29 patients will be enrolled into the trial. The main goal of this trial is to determine the dose of PPM for future clinical trials, assess the toxicity and obtain preliminary data regarding its effectiveness.
Publications & conference data
7 peer-reviewed publications reference this trial (live from Europe PMC):
-
Exploring the Application of Micellar Drug Delivery Systems in Cancer Nanomedicine.
Wang Q, Atluri K, Tiwari AK, Babu RJ. · · 2023 · cited 42× · PMID 36986532 · DOI 10.3390/ph16030433 -
State-of-the-Art Advances of Nanomedicine for Diagnosis and Treatment of Bladder Cancer.
Kong C, Zhang S, Lei Q, Wu S. · · 2022 · cited 15× · PMID 36290934 · DOI 10.3390/bios12100796 -
Advances in Polymeric Micelles: Responsive and Targeting Approaches for Cancer Immunotherapy in the Tumor Microenvironment.
Cheng L, Yu J, Hao T, Wang W, et al · · 2023 · cited 12× · PMID 38004600 · DOI 10.3390/pharmaceutics15112622 -
Nanomedicine in Bladder Cancer Therapy.
Winnicka A, Brzeszczyńska J, Saluk J, Wigner-Jeziorska P. · · 2024 · cited 11× · PMID 39408718 · DOI 10.3390/ijms251910388 -
Recent Advances in Drug Delivery Strategies for High-Risk BCG-Unresponsive Non-Muscle Invasive Bladder Cancer: A Brief Review from 2018 to 2024.
Qu F, Darji S, Thompson DH. · · 2024 · cited 11× · PMID 39339191 · DOI 10.3390/pharmaceutics16091154 -
Recent Progress in Nanomaterial-Based Biosensors and Theranostic Nanomedicine for Bladder Cancer.
Song FX, Xu X, Ding H, Yu L, et al · · 2023 · cited 10× · PMID 36671940 · DOI 10.3390/bios13010106 -
Scientific advances in drug development and clinical trials for urothelial carcinoma: Highlights from the 2025 American Society of Clinical Oncology Genitourinary Cancers Symposium
· 2025
Verify or expand the search:
- PubMed search for NCT05519241
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Non-muscle-invasive Bladder Cancer
Currently open trials in the same condition.
- NCT05796375 — Replacing Invasive Cystoscopy With Urine Testing for Non-muscle Invasive Bladder Cancer Surveillance · Phase 2 · recruiting
- NCT07494864 — Effects of Microbiological and Immunological Factors on the Lower Urinary Tract · recruiting
- NCT03528694 — Assessment of Efficacy and Safety of Durvalumab Plus BCG Compared to the Standard Therapy With BCG in Non-muscle Invasiv · Phase 3 · active not recruiting
Other VA Office of Research and Development trials
Trials by the same sponsor.
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- NCT07362576 — Perinatal Peer Support for Veterans With Serious Mental Illness · NA · not yet recruiting
- NCT06766331 — Integrated Care Versus Usual Care for Opioid Use Disorder and Infectious Diseases in Veterans · NA · not yet recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05519241 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by VA Office of Research and Development
- Last refreshed: 2 September 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05519241.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing