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 notcandidates 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 ofchildbearing potential (WOCBP) or is a WOCBP that uses highly effectivecontraception.

Exclusion Criteria:

• Received treatment with any local or systemic antineoplastic therapy within 3 weeksor 5× the plasma half-life prior to first dose of ZH9

• Major surgery or radiation within the 3 weeks prior to Screening (TURBT is notconsidered 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