Status:
ACTIVE_NOT_RECRUITING
A Phase 1/1b Study of ZH9 Treatment in Patients With Non-Muscle Invasive Bladder Cancer
Lead Sponsor:
Prokarium Ltd
Conditions:
NMIBC
High Risk NMIBC
Eligibility:
All Genders
18-99 years
Phase:
PHASE1
Brief Summary
This is a first-in-human, multicenter, Phase 1/1b, 3-part, double-blind study of ZH9 in patients with recurrent NMIBC who are eligible for intravesical therapy. In Part 1, the safety, tolerability, an...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 8 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 30 2027
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT06181266
Start Date
January 8 2024
End Date
July 30 2027
Last Update
August 19 2025
Active Locations (4)
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1
Michael G. Oefelein Clinical Trials
Bakersfield, California, United States, 93301
2
Duke Health-Duke Cancer Center
Durham, North Carolina, United States, 27710
3
Carolina Urologic Research Center, LLC
Myrtle Beach, South Carolina, United States, 29572
4
Urology San Antonio Medical Center
San Antonio, Texas, United States, 78229