drugset / Trial / NCT05375903
A Phase 1 Dose-escalation Study of UGN-301 in Patients With Recurrent Non-muscle Invasive Bladder Cancer (NMIBC)
Non-randomizedSequentialOpen-labelTreatment
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.
Timeline
- Start
- 2022-06-01
- Primary completion
- 2026-01-09
- Completion
- 2026-01-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Gemcitabine | Small molecule | — | Other |
| Subject | UGN-201 | Unknown | — | Other |
| Subject | Zalifrelimab | Monoclonal antibody | — | Other |