A Phase 1/1b Study of ZH9 Treatment in Patients With Non-Muscle Invasive Bladder Cancer
Status:
Recruiting
Trial end date:
2027-05-30
Target enrollment:
Participant gender:
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, and pharmacology of ZH9 IVI will be evaluated in a single ascending
dose (SAD) patient cohort. In Part 2, the safety, tolerability, and pharmacology of ZH9 oral
prime followed by ZH9 IVI will be evaluated in 2 patient cohorts at the doses and schedule
established in Part 1. In Part 3, the safety, pharmacology, and clinical efficacy of ZH9 will
be further evaluated in 2 expansion cohorts of patients with recurrent intermediate- and
high-risk NMIBC.