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A Phase 1, Open-label Trial of Belzupacap Sarotalocan (AU-011) in Bladder Cancer
NCT05483868 · View on ClinicalTrials.gov ↗
Study Summary
The main objectives of this study are to determine the feasibility and safety of Belzupacap Sarotalocan (AU-011, bel-sar) treatment of bladder cancer utilizing focal injections with or without laser application.
Conditions Studied
Interventions
- DRUG AU-011
- COMBINATION_PRODUCT AU-011 in Combination with Medical Laser Adminstration
- COMBINATION_PRODUCT AU-011 in Combination with Medical Laser Administration
Study Locations (17)
Texas
- Urology Clinics of North Texas — Dallas
- Baylor College of Medicine — Houston
- The University of Texas San Antonio — San Antonio
- Urology San Antonio/USA Clinical Trials — San Antonio
- The Urology Place — San Antonio
Victoria
- Austin Health — Heidelberg
- Warringal Private Hospital — Heidelberg
- Penninsula Private Hospital — Langwarrin
- The Royal Melbourne Hospital — Parkville
California
- Tower Urology — Los Angeles
- Saint John's Cancer Institute — Santa Monica
Arkansas
- Arkansas Urology — Little Rock
New York
- Montefiore Medical Center — The Bronx
South Carolina
- Carolina Urologic Research Center — Myrtle Beach
Tennessee
- Urology Associates, P.C. — Nashville
New South Wales
- Westmead Private Hospital — Westmead
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2022-09-26 |
| Est. Completion | 2027-03 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05483868
The ClinicalTrials.gov registry entry for NCT05483868 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 55 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Aura Biosciences, which has 35 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 7 conditions, with Urothelial Carcinoma Bladder appearing as the primary indexed condition, and to 3 interventions — of which AU-011 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05483868 reports 17 study locations spanning 9 distinct geographic areas — top geographies include Texas, Victoria, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05483868 about?
NCT05483868 is a clinical study titled "A Phase 1, Open-label Trial of Belzupacap Sarotalocan (AU-011) in Bladder Cancer". The main objectives of this study are to determine the feasibility and safety of Belzupacap Sarotalocan (AU-011, bel-sar) treatment of bladder cancer utilizing focal injections with or without laser application.
What is the current status of trial NCT05483868?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 55 participants. The study started on 2022-09-26. Estimated completion is 2027-03.
What conditions does trial NCT05483868 study?
This clinical trial studies the following conditions: Urothelial Carcinoma Bladder, Non-muscle-invasive Bladder Cancer, Non-Muscle Invasive Bladder Neoplasms, Non-Muscle Invasive Bladder Urothelial Carcinoma, Non-Muscle Invasive Bladder Carcinoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05483868?
The interventions under investigation include: AU-011 (DRUG), AU-011 in Combination with Medical Laser Adminstration (COMBINATION_PRODUCT), AU-011 in Combination with Medical Laser Administration (COMBINATION_PRODUCT). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05483868?
This trial is sponsored by Aura Biosciences, which has 35 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05483868 being conducted?
This trial has 17 study locations across Arkansas, California, New York, South Carolina, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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