Testing ZH9 for 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

This study is testing a new drug called ZH9 to see if it can safely help patients with recurrent non-muscle invasive bladder cancer who need treatment.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 18 Years to 99 Years
• Sex: All
• Sponsor: Prokarium Ltd (Industry-sponsored)
• Drugs / interventions: radiation
• Locations: 4 sites (Bakersfield, California and 3 other locations)
• Trial ID: NCT06181266 on ClinicalTrials.gov

What this trial studies

This is a first-in-human, multicenter, Phase 1/1b study evaluating the safety, tolerability, and pharmacology of ZH9 in patients with recurrent non-muscle invasive bladder cancer (NMIBC) who are eligible for intravesical therapy. The study consists of three parts: the first part assesses a single ascending dose of ZH9, the second part evaluates an oral prime followed by intravesical ZH9, and the third part focuses on the safety and efficacy of ZH9 in expansion cohorts of patients with intermediate- and high-risk NMIBC. The study aims to gather comprehensive data on the drug's effects and potential benefits for this patient population.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with histologically documented recurrent NMIBC who are either BCG unresponsive or unable to access BCG treatment.

Not a fit: Patients who have received recent antineoplastic therapy or have significant concurrent urinary tract infections may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with recurrent NMIBC who are unresponsive to standard therapies.

How similar studies have performed: While this approach is novel, similar studies targeting NMIBC have shown promise in exploring new treatment options.

Eligibility criteria

Inclusion 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.

Exclusion Criteria:

* 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

Where this trial is running

Bakersfield, California and 3 other locations

• Michael G. Oefelein Clinical Trials — Bakersfield, California, United States (Recruiting)
• Duke Health-Duke Cancer Center — Durham, North Carolina, United States (Recruiting)
• Carolina Urologic Research Center, LLC — Myrtle Beach, South Carolina, United States (Recruiting)
• Urology San Antonio Medical Center — San Antonio, Texas, United States (Recruiting)

Study contacts

• Study coordinator: Melinda Snyder

Conditions NMIBC; High Risk NMIBC; Non Muscle Invasive Bladder Cancer