Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
UGN-501 · 1 trial · 8 indications
The number of participants with each type of event will be summarized.
Data will be summarized using descriptive statistics.
CRR is defined as the proportion of CIS participants who achieved CR at the Week 12 (3-month) Visit.
RFS rate is defined as the proportion of participants with Ta/T1 disease who are recurrence-free at the 6-month Visit.
| Arm | Type | Description |
|---|---|---|
| UGN-501 Dose Escalation (Part 1) | EXPERIMENTAL | Dose escalation of UGN-501 in participants with recurrent NMIBC with high grade (HG) Ta and/or T1 disease and/or CIS or recurrent low grade (LG) Ta and/or T1 disease. |
| Name | Type | Description |
|---|---|---|
| UGN-501 | BIOLOGICAL | UGN-501 is administered by intravesical instillation into the bladder. Participants receive 6 once-weekly instillations during the Induction Period. Participants eligible for maintenance receive 3 once-weekly instillations quarterly from Month 3 through Month 12. |
Inclusion Criteria: 1. Participant must be 18 years of age or older at the time of signing informed consent. 2. Has confirmed recurrent non-muscle invasive bladder cancer (NMIBC) with high-grade Ta and/or T1 disease and/or carcinoma in situ (CIS), or recurrent low-grade Ta and/or T1 disease. 3. Par...
UGN-501 is an investigational monoclonal antibody being developed for the treatment of bladder cancer, specifically recurrent non-muscle invasive bladder cancer (NMIBC), which includes urothelial carcinoma of the bladder and urothelial carcinoma in situ. It is administered intravesically, meaning directly into the bladder.
UGN-501 is being developed by UroGen Pharma Ltd., a biopharmaceutical company traded on NASDAQ under the ticker symbol URGN. The company is conducting a Phase 1 clinical trial of UGN-501 in the United States.
UGN-501 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The ongoing Phase 1 trial is a dose-escalation study designed to evaluate the safety and tolerability of UGN-501 in adult participants with recurrent NMIBC.
UGN-501 is being studied in a single Phase 1 clinical trial with the identifier NCT07725796. This is a dose-escalation study of UGN-501 administered intravesically in adult participants with recurrent non-muscle invasive bladder cancer. The trial is not yet recruiting and aims to enroll 30 participants in the United States.
UGN-501 is administered intravesically, which means it is delivered directly into the bladder through a catheter. This route of administration is used for the treatment of non-muscle invasive bladder cancer to deliver the drug locally to the tumor site.