Clinical Research Directory

Inclusion Criteria: * Age ≥ 18 years * Histologically documented recurrence of NMIBC * BCG unresponsive (BCG naïve patients may be enrolled if they have received at least 1 line of adequate intravesical standard of care (SOC) treatment and are either not candidates for BCG or do not have access to BCG (e.g., BCG shortage)) * Eastern Cooperative Oncology Group Performance Status 0-1 * Adequate organ and marrow function * Highly effective contraception if risk of conception exists. * A female participant is eligible if not pregnant, not breastfeeding, not a woman of childbearing potential (WOCBP) or is a WOCBP that uses highly effective contraception. Exclusion Criteria: * Received treatment with any local or systemic antineoplastic therapy within 3 weeks or 5× the plasma half-life prior to first dose of ZH9 * Major surgery or radiation within the 3 weeks prior to Screening (TURBT is not considered major surgery) * Concurrent urinary tract infection or history of clinically significant polyuria * Symptoms consistent with typhoid * Evidence of infection within 2 weeks of the first dose of ZH9 * Significant 12-lead electrocardiogram abnormalities * History of malignancy within the previous 12 months * History of allogeneic tissue/solid organ transplant