Trials / Recruiting
RecruitingNCT05483868
A Phase 1, Open-label Trial of Belzupacap Sarotalocan (AU-011) in Bladder Cancer
A Phase 1, Open-label Trial of Belzupacap Sarotalocan (AU-011) to Determine the Feasibility and Safety of Intratumoral Injection With or Without Intramural Injection in Subjects With Bladder Cancer
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 55 (estimated)
- Sponsor
- Aura Biosciences · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
Aura is enrolling participants with urothelial carcinoma to evaluate the safety, technical feasibility, and preliminary efficacy of bel-sar. The goal is to achieve the trial objectives with minimal disruption to the standard of care (SoC) of the treating Investigator.
Conditions
- Non-muscle-invasive Bladder Cancer
- NMIBC
- Non-Muscle Invasive Bladder Carcinoma
- Non-Muscle Invasive Bladder Neoplasms
- Non-Muscle Invasive Bladder Urothelial Carcinoma
- Urothelial Carcinoma Bladder
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | AU-011 | Administration of AU-011 intratumorally and intramurally |
| COMBINATION_PRODUCT | AU-011 in Combination with Medical Laser Adminstration | AU-011 Intratumorally and Intramurally |
| COMBINATION_PRODUCT | AU-011 in Combination with Medical Laser Administration | AU-011 Intratumorally |
Timeline
- Start date
- 2022-09-26
- Primary completion
- 2027-03-01
- Completion
- 2027-03-01
- First posted
- 2022-08-02
- Last updated
- 2026-04-15
Locations
17 sites across 2 countries: United States, Australia
Regulatory
- FDA-regulated drug study
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05483868. Inclusion in this directory is not an endorsement.