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

Study Identifier:
PRK-23101
CT.gov Identifier:
NCT06181266
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
(210) 593-5651 or [email protected]
Recruitment Complete

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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.

To initially evaluate the safety of a single intravesical administration of their investigational immunotherapy, ZH9, in NMIBC patients. The study will further investigate and characterize clinical efficacy of the ZH9 treatment regimen in pre-planned expansion cohorts under the same IND.

To redesign the treatment paradigm for non-muscle invasive bladder cancer patients through a single-dose intravesical induction regimen.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Bladder
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I
    Sex
    Female & Male
    Age
    18 - 99 Years
    Study Drug
  • Drug: Experimental: Dose Level 1 - ZH9
    • Read More
  • Drug: Experimental: Dose Level 2 - ZH9
  • Drug: Experimental: Dose Level 3 - ZH9
  • Drug: Experimental: Dose Level 4 - ZH9
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruitment Complete

    Requirements information
    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

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Carolinas
    Myrtle Beach, SC, United States, 29572
    Investigator
    Neal Shore
    Status
    Recruitment Complete
    Condition(s) Treated at Site
    Bladder