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

MC #UC23-01

Urothelial Cancer
Molecular Target(s)
Not Required
Drug Classification(s)
Virus-like drug conjugate
AU-011, Medical Laser

Mechanism of Action

Virus-like drug conjugate (VDC) composed of the VLP as the
targeting component and the phthalocyanine dye as the cytotoxic payload


This purpose of this study is to obtain information on the safety and possible effectiveness (how
well the drug works) of the study drug (bel-sar) when it is given as an injection in the wall of the
bladder and within the bladder tumor. The distribution of the study drug will also be studied to
confirm how far an injection of the study drug will travel in the wall of the bladder. A laser light
may also be applied to the tumor as part of the procedure depending on the group you are enrolled
in. The study will also evaluate how the body processes bel-sar and how well the procedure is



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