Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| High Risk NMIBC | — | UNRESOLVED | — |
| NMIBC | Non-Muscle Invasive Bladder Carcinoma | ALIAS | 0.90 |
| Non Muscle Invasive Bladder Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ZH9 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Dose Level 1 - ZH9
- description
- Part 1 will evaluate SAD of ZH9 administered as an IVI in patients with recurrent NMIBC. A standard 3+3 escalation design will be employed with the dose levels
- interventionNames
- Drug: ZH9
- type
- EXPERIMENTAL
- label
- Dose Level 2 - ZH9
- description
- Part 1 will evaluate SAD of ZH9 administered as an IVI in patients with recurrent NMIBC. A standard 3+3 escalation design will be employed with the dose levels
- interventionNames
- Drug: ZH9
- type
- EXPERIMENTAL
- label
- Dose Level 3 - ZH9
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available