# A Phase 1 Dose-escalation Study of UGN-301 in Patients With Recurrent Non-muscle Invasive Bladder Cancer (NMIBC)

> **NCT05375903** · PHASE1 · COMPLETED · sponsor: **UroGen Pharma Ltd.** · enrollment: 51 (actual)

## Conditions studied

- Non-muscle Invasive Bladder Cancer
- NMIBC
- Carcinoma in Situ of Bladder
- Bladder Cancer
- Urothelial Carcinoma Bladder
- Urothelial Carcinoma Recurrent

## Interventions

- **DRUG:** UGN-301
- **DRUG:** UGN-201
- **DRUG:** Gemcitabine

## Key facts

- **NCT ID:** NCT05375903
- **Lead sponsor:** UroGen Pharma Ltd.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE1
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2022-06-01
- **Primary completion:** 2026-01-09
- **Final completion:** 2026-01-09
- **Target enrollment:** 51 (ACTUAL)
- **Last updated:** 2026-01-14


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT05375903

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT05375903, "A Phase 1 Dose-escalation Study of UGN-301 in Patients With Recurrent Non-muscle Invasive Bladder Cancer (NMIBC)". Retrieved via AI Analytics 2026-07-07 from https://api.ai-analytics.org/clinical/NCT05375903. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*