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NCT06181266 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Non-muscle Invasive Bladder Cancer and NMIBC, sponsored by Prokarium.

Active
Registry status
Phase 1
Development phase
22
Enrollment target
4
Study locations

NCT06181266 is a Phase 1 study of Non-muscle Invasive Bladder Cancer and NMIBC that is active but no longer recruiting, run by Prokarium. The registered enrollment target is 22 participants, below the 232-participant average among 28 other Non-muscle Invasive Bladder Cancer trials with a reported enrollment target (91% lower). The trial reports 4 study locations across 4 states.

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The verdict

NCT06181266, a Phase 1 study of Non-muscle Invasive Bladder Cancer and NMIBC, is active but no longer recruiting, sponsored by Prokarium.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
22 participants
Enrollment target
4
Study locations

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

Non-muscle Invasive Bladder Cancer NMIBC High Risk NMIBC

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

FieldValue
Enrollment Target 22 participants
Start Date 2024-01-08
Est. Completion 2027-07-30
Phase Phase 1

Sponsor

Prokarium

1 total trials

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What the Registry Record Tells You About NCT06181266

The ClinicalTrials.gov registry entry for NCT06181266 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 22 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 232-participant average among 28 other Non-muscle Invasive Bladder Cancer trials with a reported enrollment target (91% lower). The listed sponsor is Prokarium, which has 1 total studies on file at ClinicalTrials.gov.

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.

NCT06181266 reports 4 study locations spanning 4 distinct geographic areas - top geographies include California, North Carolina, South Carolina.

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.

What interventions are being tested in trial NCT06181266?

The interventions under investigation include: ZH9 (DRUG).

Who is sponsoring clinical trial NCT06181266?

This trial is sponsored by Prokarium, which has 1 total clinical trials registered on ClinicalTrials.gov.

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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