Brief Title: ZH9 Treatment in Patients With Non-Muscle Invasive Bladder Cancer

PRIMARY OUTCOMES

Primary Outcome 1 - Measure:

Primary Outcome 1 - Timeframe: N/A

CONDITION

• NMIBC
• High Risk NMIBC
• Non Muscle Invasive Bladder Cancer

ELIGIBILITY

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Josefin-Beate Holz, MD

Role: Study Director

Affiliation: Prokarium Ltd

Overall Contact

Name: Melinda Snyder

Phone: 6172334057

Email: melinda.snyder@prokarium.com

LOCATION