ACTIVE_NOT_RECRUITING

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

Conditions

NMIBC High Risk NMIBC Non Muscle Invasive Bladder Cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-01-08

Study Completion:2027-07-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06181266

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 99 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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

Inclusion Criteria

Exclusion 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.

* 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

Contacts and Locations

Principal Investigator

Josefin-Beate Holz, MD

STUDY_DIRECTOR

Prokarium Ltd

Study Locations (Sites)

Michael G. Oefelein Clinical Trials

Bakersfield, California, 93301

United States

Duke Health-Duke Cancer Center

Durham, North Carolina, 27710

United States

Carolina Urologic Research Center, LLC

Myrtle Beach, South Carolina, 29572

United States

Urology San Antonio Medical Center

San Antonio, Texas, 78229

United States

Collaborators and Investigators

Sponsor: Prokarium Ltd

Josefin-Beate Holz, MD, STUDY_DIRECTOR, Prokarium Ltd

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-08

Study Completion Date2027-07-30

Study Record Updates

Study Start Date2024-01-08

Study Completion Date2027-07-30

Terms related to this study

Additional Relevant MeSH Terms

NMIBC
High Risk NMIBC
Non Muscle Invasive Bladder Cancer