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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05375903 | A Phase 1 Dose-escalation Study of UGN-301 in Patients With Recurrent Non-muscle Invasive Bladder Cancer (NMIBC) | PHASE1 | COMPLETED | 51 | — | — | Jun 1, 2022 | Jan 9, 2026 | Jan 14, 2026 | 13 | United States, Italy +1 |
The number of patients with each type of event will be summarized.
Data will be summarized using descriptive statistics.
CRR is defined as the proportion of CIS patients who achieved CR at the Week 12 (3-month) Visit.
RFS rate is defined as the proportion of patients with Ta/T1 disease who are recurrence-free at the Week 12 (3-month) Visit.
| Arm | Type | Description |
|---|---|---|
| UGN-301 monotherapy dose escalation (Arm A) | EXPERIMENTAL | Dose escalation of UGN-301 monotherapy in patients with recurrent NMIBC with high grade (HG) Ta and/or T1 disease and/or CIS or recurrent intermediate risk (IR) low grade (LG) Ta and/or T1 disease. |
| UGN-301 dose escalation + UGN-201 combination (Arm B) | EXPERIMENTAL | Dose escalation of UGN-301 in combination with a fixed dose of UGN-201 in patients with recurrent NMIBC with HG Ta and/or T1 disease and/or CIS. |
| UGN-301 dose escalation + gemcitabine combination (Arm C) | EXPERIMENTAL | Dose escalation of UGN-301 in combination with a fixed dose of gemcitabine in patients with recurrent NMIBC with HG Ta and/or T1 disease and/or CIS. |
| Name | Type | Description |
|---|---|---|
| UGN-301 | DRUG | Induction Period: Intravesical administration once weekly for 6 weeks. Optional Maintenance Period: Intravesical administration once every 3 months (at 6, 9, and 12 months after the start of treatment). |
| UGN-201 | DRUG | Induction Period: Intravesical administration once weekly for 6 weeks. Optional Maintenance Period: Intravesical administration once every 3 months (at 6, 9, and 12 months after the start of treatment). |
| Gemcitabine | DRUG | Induction Period: Intravesical administration once weekly for 6 weeks. Optional Maintenance Period: Intravesical administration once every 3 months (at 6, 9, and 12 months after the start of treatment). |
Inclusion Criteria: 1. Able to give informed consent. 2. Arm A: Have confirmed recurrent NMIBC with HG Ta and/or T1 disease and/or CIS or recurrent IR LG Ta and/or T1 disease. Arm B: Have confirmed recurrent NMIBC with HG Ta and/or T1 disease and/or CIS. Arm C: Have confirmed recurrent NMIBC wi...