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

Description

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

NMIBC, High Risk NMIBC, Non Muscle Invasive Bladder Cancer

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Study Overview

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Study Details

Study overview

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.

A Phase 1/1b Study Evaluating the Safety, Pharmacology, and Clinical Effect of ZH9 Treatment in Patients With Non-Muscle Invasive Bladder Cancer

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

Condition
NMIBC
Intervention / Treatment

-

Contacts and Locations

Bakersfield

Michael G. Oefelein Clinical Trials, Bakersfield, California, United States, 93301

Hanover

Chesapeake Urology, Hanover, Maryland, United States, 21076

Durham

Duke Health-Duke Cancer Center, Durham, North Carolina, United States, 27710

Myrtle Beach

Carolina Urologic Research Center, LLC, Myrtle Beach, South Carolina, United States, 29572

San Antonio

Urology San Antonio Medical Center, San Antonio, Texas, United States, 78229

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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

Ages Eligible for Study

18 Years to 99 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Prokarium Ltd,

Josefin-Beate Holz, MD, STUDY_DIRECTOR, Prokarium Ltd

Study Record Dates

2027-07-30