NCT06181266CompletedPhase 1
A Phase 1/1b Study of ZH9 Treatment in Patients With Non-Muscle Invasive Bladder Cancer
A Phase 1/1b Study Evaluating the Safety, Pharmacology, and Clinical Effect of ZH9 Treatment in Patients With Non-Muscle Invasive Bladder Cancer
Source: ClinicalTrials.gov · Last updated 14 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 22 (actual)
- First submitted
- 12 Dec 2023
- Start date
- 8 Jan 2024
- Primary completion date
- 30 Aug 2025
- Lead sponsor
- Prokarium Ltd
- Diseases
- Bladder cancer
- NCT number
- NCT06181266
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 22
- From 8 Jan 2024 to the primary completion date, 30 Aug 2025
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Evidence of infection within 2 weeks of the first dose of ZH9
- History of malignancy within the previous 12 months
- History of allogeneic tissue/solid organ transplant
Other
- Symptoms consistent with typhoid
- Significant 12-lead electrocardiogram abnormalities
Who the study is looking for
- 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.
Age in the registry: 18 years to 99 years · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Michael G Oefelein Clinical Trials Coordinator of this site? Confirm its status | Bakersfield | United States | Unknown status |
| Duke Health - Duke Cancer Center Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
| Carolina Urologic Research Center, LLC Coordinator of this site? Confirm its status | Myrtle Beach | United States | Unknown status |
| Urology San Antonio Medical Center Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.