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NCT05483868 · ClinicalTrials.gov registry record · Phase 1
A Phase 1, Open-label Trial of Belzupacap Sarotalocan (AU-011) in Bladder Cancer
A Phase 1 study of Non-muscle Invasive Bladder Cancer and Urothelial Carcinoma Bladder, sponsored by Aura Biosciences.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 55
- Enrollment target
- 17
- Study locations
NCT05483868: Recruiting Phase 1 study of Non-muscle Invasive Bladder Cancer and Urothelial Carcinoma Bladder, sponsored by Aura Biosciences.
NCT05483868 is a Phase 1 study of Non-muscle Invasive Bladder Cancer and Urothelial Carcinoma Bladder that is actively recruiting participants, run by Aura Biosciences. The registered enrollment target is 55 participants, below the 225-participant average among 30 other Non-muscle Invasive Bladder Cancer trials with a reported enrollment target (76% lower). The trial reports 17 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05483868, a Phase 1 study of Non-muscle Invasive Bladder Cancer and Urothelial Carcinoma Bladder, is actively recruiting participants, sponsored by Aura Biosciences.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 55 participants
- Enrollment target
- 17
- Study locations
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.
Primary Outcome
Incidence and severity of treatment-related adverse events \[time frame 12 months\], serious adverse events \[time frame 12 months\], and incidence of dose-limiting toxicities \[time frame 14 days\]
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 |
What NCT05483868 shows while recruiting
NCT05483868 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, below the 225-participant average among 30 other Non-muscle Invasive Bladder Cancer trials with a reported enrollment target (76% lower).
The record links to 7 conditions, with Non-muscle Invasive Bladder Cancer appearing as the primary indexed condition, and to 3 interventions - of which AU-011 is the first listed.
NCT05483868 lists 17 locations in 9 states (Texas, Victoria, California).
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: Non-muscle Invasive Bladder Cancer, Urothelial Carcinoma Bladder, Non-Muscle Invasive Bladder Neoplasms, Non-Muscle Invasive Bladder Urothelial Carcinoma, Non-Muscle Invasive Bladder Carcinoma.
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).
Who is sponsoring clinical trial NCT05483868?
This trial is sponsored by Aura Biosciences, which has 7 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT05483868's enrollment target sits among peer trials
55 20th of 30 higher than 10 of 30 other Non-muscle Invasive Bladder Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-muscle Invasive Bladder Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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