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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 is a Phase 1 study that has completed, run by UroGen Pharma. The registered enrollment target is 51 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05375903
The ClinicalTrials.gov registry entry for NCT05375903 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 51 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is UroGen Pharma, which has 9 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Gemcitabine is the first listed.
NCT05375903 reports 0 study locations.
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.
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