Bladder Cancer Clinical Trial
A Phase 1, Open-label Trial of Belzupacap Sarotalocan (AU-011) in Bladder Cancer
The main objectives of this study are i) to evaluate the incidence of AU-011 treatment-related adverse events, serious adverse events (SAEs) and dose-limiting toxicities (DLTs) and ii) to determine the feasibility of AU-011 treatment of non-muscle invasive bladder cancer utilizing intramural with or without intratumoral injection.
Aura is conducting a Phase 1, 'window of opportunity', open-label trial of belzupacap sarotalocan (AU-011) to determine the feasibility and safety of intratumoral injection with or without intramural injection and with or without laser application in subjects with bladder cancer.
Confirmed diagnosis of NMIBC or MIBC. Biopsy or pathology must be obtained within 6 months prior to enrollment
Have no evidence of metastatic disease
Have a normal upper urinary tract
Adequate bone marrow, renal, and hepatic function
Any additional malignancy that requires active treatment. Exceptions include:
Basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy with evidence of remission for at least 1 year.
In situ cervical cancer treated and with at least 1 year without recurrence.
Any other subject felt appropriate by the Investigator upon discussion with trial's Medical Monitor.
Used an investigational drug or medical device within 30 days or 5 half-lives (whichever is longer) of Visit 1 or be concurrently enrolled in another investigational trial.
Active bacterial, fungal, or viral infections - all prior infections must have resolved following optimal therapy and subject must be off all systemic anti-infective agents.
Chronic active hepatitis B or C and HIV.
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