A Phase 1/1b Study of ZH9 Treatment in Patients With Non-Muscle Invasive Bladder Cancer

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