A Phase 1, Open-label Trial of Belzupacap Sarotalocan (AU-011) in Bladder Cancer
Recruiting
Phase 1
Interventional Study
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
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 1
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 55 (estimated)
- Sponsor
- Aura Biosciences · Industry
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About This Trial
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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Meet the following histopathologic requirements for urothelial carcinoma:
* For Cohorts 1b, 4a-c:
histopathological diagnosis of NMIBC (any grade) is required. For participants with first diagnosis of NMIBC, confirmation of urothelial carcinoma by recent biopsy (≤6 mo…
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