Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT06181266
Study type Interventional
Source Prokarium Ltd
Contact Melinda Snyder
Phone 6172334057
Email melinda.snyder@prokarium.com
Status Recruiting
Phase Phase 1
Start date January 8, 2024
Completion date May 30, 2027

See also
  Status Clinical Trial Phase
Completed NCT06020807 - Analytical Specificity of Bladder EpiCheck Test in Healthy Population and Urology Patients Without Prior History or Evidence of Bladder Cancer
Recruiting NCT04452591 - Study of Cretostimogene Given in Patients With Non-Muscle Invasive Bladder Cancer ,Unresponsive to Bacillus-Calmette-Guerin Phase 3
Recruiting NCT06167356 - Study on the Occurrence of Possible Relapses and on the Quality of Life in Patients Who Underwent TURBK.
Withdrawn NCT01799499 - A Prospective Open Label Comparative Dose Ranging Study Evaluating the Effect of Pre-TURBT Intravesical Instillation of Mitomycin C (MMC) Mixed With TC-3 Gel in Patients With Non Muscle Invasive Bladder Cancer (NMIBC) N/A
Completed NCT02343614 - Celecoxib for the Treatment of Non-muscle Invasive Bladder Cancer Phase 2
Recruiting NCT05945108 - Brazilian Reality of Urinary Bladder Cancers - BRA-BLADDER
Recruiting NCT06287541 - The Necessity of a Second Transurethral Resection in High-risk Non-muscle-invasive Bladder Cancer Patients With Negative Urine Biomarker After Initial Transurethral Resection N/A
Terminated NCT02982395 - Study to Evaluate the Efficacy and Safety Of Intravesical Nanoxel®M In BCG Refractory NMIBC Phase 3
Completed NCT06205277 - Predictors of Residual Tumor at Second Transurethral Resection for pT1 Non-muscle Invasive Bladder Cancer
Completed NCT01731652 - Study With TMX-101 in Patients With Carcinoma In Situ (CIS) Bladder Cancer Phase 2
Recruiting NCT03421236 - Intravesical Ty21a for the Treatment of Patients With Non-muscle-invasive Bladder Cancer (NMIBC) Phase 1
Active, not recruiting NCT04387461 - Study of CG0070 Given in Combination With Pembrolizumab, in Non-Muscle Invasive Bladder Cancer, Unresponsive to Bacillus Calmette-Guerin Phase 2
Recruiting NCT06111235 - A Study of Adjuvant Cretostimogene Grenadenorepvec for Treatment of Intermediate Risk NMIBC Following TURBT Phase 3
Recruiting NCT02895620 - Effect on Xpert® Bladder Test of Urines Inflammatory Milieu Induced by BCG Treatment of Patients With NMIBC N/A
Completed NCT01004211 - Prospective Randomized Comparison of Transurethral Resection by Mean of White Light and Narrow Band Imaging N/A
Active, not recruiting NCT05981131 - Follow up of Intravesical N-803 Plus BCG in BCG-Naive Non-Muscle Invasive Bladder Cancer (NMIBC)