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

Inclusion Criteria19

• 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