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

Study acronym: PARADIGM-1
StatusCompleted
PhasePhase 1
Started

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Record History

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  1. Trial completed
    • Study completion date changed from estimate of Jul 30, 2027 to Aug 5, 2026
    • Eligibility criteria expanded, about 15 words
  2. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 24 to confirmed 22
    • Site details revised at 4 of 4 sites
    v10
  3. Re-verified, no change to tracked fieldsv9
  4. Primary completion date: Jun 3, 2025 to Aug 30, 2025v8
  5. Site contacts updated at 4 of 4 sitesv7
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  1. Study sites: 5 to 4v6
  2. Re-verified, no change to tracked fieldsv5
  3. Study sites: 3 to 5
    • Primary completion date: Feb 3, 2025 to Jun 3, 2025
    • Study completion date: May 30, 2027 to Jul 30, 2027
    v4
  4. Study sites: 2 to 3v3
  5. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 1 to 2
    • Start date changed from estimate of Jan 3, 2024 to Jan 8, 2024
    v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06181266
Lead Sponsor Prokarium Ltd
Conditions
(from sponsor)		 NMIBC, High Risk NMIBC, Non Muscle Invasive Bladder Cancer
Related terms Non-Muscle Invasive Bladder Neoplasms
Enrollment 22 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov