A Phase 1 Dose-escalation Study of UGN-301 in Patients With Recurrent Non-muscle Invasive Bladder Cancer (NMIBC)
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Phase
Phase 1
Status
Completed
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
51actual
Sites
13
Countries
Italy, Spain, United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2022-06-01 | actual | When the study began enrolling |
| Primary completion | 2026-01-09 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-01-09 | actual | The whole study's end, after follow-up |
| First posted | 2022-05-17 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-01-14 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Non-muscle Invasive Bladder Cancer
- NMIBC
- Carcinoma in Situ of Bladder
- Bladder Cancer
- Urothelial Carcinoma Bladder
- Urothelial Carcinoma Recurrent
Interventions
- Drug: UGN-301 — also filed as UGN-301 (zalifrelimab) intravesical solution
- Drug: UGN-201 — also filed as UGN-201 (imiquimod) intravesical solution
- Drug: Gemcitabine
Primary outcomes
what the primary-completion date above is the date OFIncidence of dose-limiting toxicities (DLTs) and treatment-emergent adverse events (TEAEs)
measured Up to 15 months
Concentration of UGN-301 in blood and urine
measured 6 weeks
Complete response rate (CRR)
measured 3 months
Recurrence-free survival (RFS) rate
measured 3 months
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