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

INTRODUCTION

  • Org Study ID: PRK-23101
  • Secondary ID: N/A
  • NCT ID: NCT06181266
  • Sponsor: Prokarium Ltd

BRIEF 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.

  • Overall Status
    Recruiting
  • Start Date
    January 8, 2024
  • Phase
    Phase 1
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure:

Primary Outcome 1 - Timeframe: N/A

CONDITION

  • NMIBC
  • High Risk NMIBC
  • Non Muscle Invasive Bladder Cancer

ELIGIBILITY

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Josefin-Beate Holz, MD

Role: Study Director

Affiliation: Prokarium Ltd

Overall Contact

Name: Melinda Snyder

Phone: 6172334057

Email: melinda.snyder@prokarium.com

LOCATION

Facility Status Contact
Facility: Chesapeake Urology
Hanover, Maryland 21076
United States
Status: Recruiting Contact: Contact
Barbara Kyei
443-231-1313
bkyei@chesuro.com

Principal Investigator
Rian Dickstein, MD

Facility: Urology San Antonio Medical Center
San Antonio, Texas 78229
United States
Status: Recruiting Contact: Contact
Gavon Payne, BS
gavon.payne@usa-clinicaltrials.com

Principal Investigator
Daniel Zainfeld, MD