NCT06181266

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

A Phase 1/1b Study Evaluating the Safety, Pharmacology, and Clinical Effect of ZH9 Treatment in Patients With Non-Muscle Invasive Bladder Cancer

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Prokarium Ltd · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
DRUG	ZH9	ZH9 is a live attenuated S. enterica serovar Typhi ZH9 \[Ty2 ΔaroC ΔssaV\]), a differentiated novel microbial immunotherapy.

Timeline

• Start date: 2024-01-08
• Primary completion: 2025-08-30
• Completion: 2027-07-30
• First posted: 2023-12-26
• Last updated: 2025-08-19

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study