A Phase 1, Open-label Trial of Belzupacap Sarotalocan (AU-011) in Bladder Cancer

Inclusion criteria

• 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 months of Screening Visit) is required. Participants with recurrent NMIBC must have a current lesion that clinically appears to be NMIBC with histopathologic confirmation based on TURBT or biopsy within the last 24 months). For Cohorts 4d, 4e, 4g and 4h, a diagnosis of LG IR NMIBC (according to AUA risk classification guidelines) is required, specifically:
• Multifocal LG Ta; OR
• Solitary LG Ta \>3 cm; OR
• Low-grade Ta with prior recurrence(s) within 1 year. For Cohorts 4f and 4i, a diagnosis of HR NMIBC (according to AUA risk classification guidelines) is required, specifically:
• Ta HG papillary disease with or without CIS; OR
• T1 papillary disease with or without CIS
• Participants may be BCG-naïve or may have received prior treatment with BCG for HR or IR NMIBC (BCG-exposed, BCG-failed, BCG-intolerant)
• BCG-refractory participants are excluded. BCG-refractory is defined by the following:
• Persistent HG disease at 6 months following adequate BCG (defined as ≥5/6 induction instillations and ≥2 additional doses, either from re-induction or maintenance), OR
• HG T1 disease at first evaluation (3 months) after BCG, OR
• Persistent CIS that remains despite a second BCG course, OR
• Disease progression in stage or grade during BCG therapy, including maintenance
• Have no evidence of current or prior metastatic urothelial carcinoma
• Adequate bone marrow, renal, and hepatic function

Exclusion criteria

• 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.
• Chronic active hepatitis B or C and HIV.