Bladder Cancer Clinical Trial
A Phase 1, Open-label Trial of Belzupacap Sarotalocan (AU-011) in Bladder Cancer
Summary
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.
Full Description
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.
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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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