AU-011-102: Evaluating how safe, effective and feasible an injectable targeted cancer treatment called AU-011 is for people with non-muscle-invasive bladder cancerA 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

Inclusion

1. 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
2. Have no evidence of current or prior metastatic urothelial carcinoma
3. Adequate bone marrow, renal, and hepatic function