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

Launched by PROKARIUM LTD · Dec 12, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called ZH9 for patients with a type of bladder cancer known as non-muscle invasive bladder cancer (NMIBC). The trial is designed to test how safe and effective ZH9 is in helping patients whose cancer has come back and who are eligible for certain types of therapy. The study has three parts: the first focuses on testing different doses of ZH9 to see how well the body tolerates it; the second looks at a combination of ZH9 given in two different ways; and the third evaluates how effective ZH9 is in treating patients with intermediate- and high-risk NMIBC.

To be eligible for this trial, participants must be at least 18 years old and have a confirmed diagnosis of recurrent NMIBC. They should not have had recent treatments that could interfere with the study, and they must be in good overall health. Participants can expect to receive close medical supervision throughout the trial and to be part of a groundbreaking study that may help improve treatment options for bladder cancer in the future. If you or a loved one is interested, it's a great opportunity to contribute to medical research while receiving potentially beneficial treatment.

Gender

ALL

Eligibility criteria

• 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