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NCT05375903 · ClinicalTrials.gov registry record · Phase 1
A Phase 1 Dose-escalation Study of UGN-301 in Patients With Recurrent Non-muscle Invasive Bladder Cancer (NMIBC)
A Phase 1 study, sponsored by UroGen Pharma.
- Completed
- Registry status
- Phase 1
- Development phase
- 51
- Enrollment target
NCT05375903: Completed Phase 1 study, sponsored by UroGen Pharma.
NCT05375903 is a Phase 1 study that has completed, run by UroGen Pharma. The registered enrollment target is 51 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (15% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05375903, a Phase 1 study, has completed, sponsored by UroGen Pharma.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 51 participants
- Enrollment target
Study Summary
This study is being conducted to evaluate the safety and determine the recommended Phase 2 dose (RP2D) of UGN-301 (zalifrelimab) administered intravesically as monotherapy and in combination with other agents in patients with recurrent NMIBC.
Primary Outcome
The number of patients with each type of event will be summarized.
Interventions
- DRUG Gemcitabine
- DRUG UGN-201
- DRUG UGN-301
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2022-06-01 |
| Est. Completion | 2026-01-09 |
| Phase | Phase 1 |
What the finished NCT05375903 record still lists
NCT05375903 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (15% lower).
The record links to 0 conditions, and to 3 interventions - of which Gemcitabine is the first listed.
NCT05375903 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05375903 about?
NCT05375903 is a clinical study titled "A Phase 1 Dose-escalation Study of UGN-301 in Patients With Recurrent Non-muscle Invasive Bladder Cancer (NMIBC)". This study is being conducted to evaluate the safety and determine the recommended Phase 2 dose (RP2D) of UGN-301 (zalifrelimab) administered intravesically as monotherapy and in combination with other agents in patients with recurrent NMIBC.
What is the current status of trial NCT05375903?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 51 participants. The study started on 2022-06-01. Estimated completion is 2026-01-09.
What interventions are being tested in trial NCT05375903?
The interventions under investigation include: Gemcitabine (DRUG), UGN-201 (DRUG), UGN-301 (DRUG).
Who is sponsoring clinical trial NCT05375903?
This trial is sponsored by UroGen Pharma, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05375903's enrollment target sits among peer trials
51 969th of 2000 higher than 1,028 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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