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.
Multifocal LG Ta; OR
Solitary LG Ta >3 cm; OR
Low-grade Ta with prior recurrence(s) within 1 year.
Ta HG papillary disease with or without CIS; OR
Any additional malignancy that requires active treatment, unless deemed appropriate after discussion by the Investigator with the 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.
Active autoimmune disease, chronic inflammatory condition, or other conditions (like solid organ transplant or bone marrow allograft) requiring concurrent use of any systemic immunosuppressants or steroids.
Sequential
AU-011
DrugAdministration of AU-011 intratumorally and intramurally
AU-011 in Combination with Medical Laser Adminstration
Combination productAU-011 Intratumorally and Intramurally
AU-011 in Combination with Medical Laser Administration
Combination productAU-011 Intratumorally
10
Treatment groupsSee each treatment group below.
Safety of AU-011: Incidences of SAEs and DLTs
Incidence and severity of treatment-related adverse events \[time frame 12 months\], serious adverse events \[time frame 12 months\], and incidence of dose-limiting toxicities \[time frame 14 days\]
Complete response (CR) rate
for all cohorts
Duration of response (DoR)
In participants who achieve CR
Durable CR rate
Proportion of participants maintaining a CR after achieving a CR
Recurrence-free survival (RFS)
Participants in neoadjuvant cohorts
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