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A Phase 1/1b Study of ZH9 Treatment in Patients With Non-Muscle Invasive Bladder Cancer
NCT06181266 · View on ClinicalTrials.gov ↗
Study 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 Studied
Interventions
- DRUG ZH9
Study Locations (4)
California
- Michael G. Oefelein Clinical Trials — Bakersfield
North Carolina
- Duke Health-Duke Cancer Center — Durham
South Carolina
- Carolina Urologic Research Center, LLC — Myrtle Beach
Texas
- Urology San Antonio Medical Center — San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2024-01-08 |
| Est. Completion | 2027-07-30 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06181266
The ClinicalTrials.gov registry entry for NCT06181266 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 22 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Prokarium, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Non Muscle Invasive Bladder Cancer appearing as the primary indexed condition, and to 1 intervention — of which ZH9 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06181266 reports 4 study locations spanning 4 distinct geographic areas — top geographies include California, North Carolina, South Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06181266 about?
NCT06181266 is a clinical study titled "A Phase 1/1b Study of ZH9 Treatment in Patients With Non-Muscle Invasive Bladder Cancer". 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...
What is the current status of trial NCT06181266?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2024-01-08. Estimated completion is 2027-07-30.
What conditions does trial NCT06181266 study?
This clinical trial studies the following conditions: Non Muscle Invasive Bladder Cancer, NMIBC, High Risk NMIBC. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06181266?
The interventions under investigation include: ZH9 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06181266?
This trial is sponsored by Prokarium, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06181266 being conducted?
This trial has 4 study locations across California, North Carolina, South Carolina, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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