Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06331299 | A Phase 3 Study of UGN-103 for Treatment of Patients With Low-grade Intermediate-risk Non-muscle Invasive Bladder Cancer | PHASE3 | ACTIVE NOT_RECRUITING | 99 | — | — | Aug 29, 2024 | Sep 1, 2026 | Jan 15, 2026 | 48 | United States, Bulgaria +5 |
CRR is defined as the proportion of patients who achieved CR at the 3-month Visit.
| Arm | Type | Description |
|---|---|---|
| UGN-103 | EXPERIMENTAL | Patients will receive UGN-103 (75 mg mitomycin) once weekly for 6 weeks (a total of 6 doses). |
| Name | Type | Description |
|---|---|---|
| UGN-103 | DRUG | UGN-103 consists of mitomycin and sterile hydrogel (a proprietary thermally responsive gel) that is used to reconstitute mitomycin before instillation. The reverse thermal properties of UGN-103 allow for local administration of mitomycin as a liquid under chilled conditions, with subsequent conversion to a semi-solid gel depot following instillation into the bladder. |
Inclusion Criteria: 1. Provide written informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and the protocol. 2. Patient who has LG-NMIBC (Ta) histologically confirmed by cold cup biopsy at Screening or within 8 weeks before Sc...