A Phase 3 Single-arm Study of UGN-104 for the Treatment of Low-grade Upper Tract Urothelial Cancer
← catalyst calendarNCT06774131 · readout ≤ 223 d
Sponsored by UroGen Pharma Ltd. (industry) · URGN — their whole pipeline →.
Phase
Phase 3
Status
Recruiting
Study type
Interventional
Design
Na · None · Treatment
Enrollment
70estimated
Sites
62
Countries
Bulgaria, Georgia, Hungary +6
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 | 2025-08-06 | actual | When the study began enrolling |
| Primary completion | Mar 2027 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Mar 2028 | estimated | The whole study's end, after follow-up |
| First posted | 2025-01-14 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-06-16 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Upper Urinary Tract Urothelial Carcinoma
- Urothelial Carcinoma
Intervention
- Drug: UGN-104 — also filed as UGN-104 (mitomycin) for pyelocalyceal solution
Primary outcome
what the primary-completion date above is the date OFComplete response rate (CRR)
measured 3 months
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