A Phase 1 Dose-escalation Study of UGN-301 in Patients With Recurrent Non-muscle Invasive Bladder Cancer (NMIBC)
Public ClinicalTrials.gov record NCT05375903. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 1, Open-label, Dose-escalation Study to Investigate the Safety, Tolerability, and Pharmacokinetics of UGN-301 (Zalifrelimab) Administered Intravesically as Monotherapy and in Combination With Other Agents in Patients With Recurrent NMIBC
Study identification
- NCT ID
- NCT05375903
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Lead sponsor
- UroGen Pharma Ltd.
- Industry
- Enrollment
- 51 participants
Conditions and interventions
Conditions
Interventions
- Gemcitabine Drug
- UGN-201 Drug
- UGN-301 Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 31, 2022
- Primary completion
- Jan 8, 2026
- Completion
- Jan 8, 2026
- Last update posted
- Jan 13, 2026
2022 – 2026
United States locations
- U.S. sites
- 7
- U.S. states
- 7
- U.S. cities
- 7
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Arkansas Urology | Little Rock | Arkansas | 72211 | — |
| UCLA - University of California | Los Angeles | California | 90095 | — |
| Florida Urology Partners, LLC | Tampa | Florida | 33615 | — |
| Johns Hopkins University | Baltimore | Maryland | 21287 | — |
| Manhattan Medical Research | New York | New York | 10016 | — |
| Clinical Research Solutions | Middleburg Heights | Ohio | 44130 | — |
| Penn State Milton S Hershey Medical Center | Hershey | Pennsylvania | 17033 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 6 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05375903, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 13, 2026 · Synced May 18, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05375903 live on ClinicalTrials.gov.