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 being developed for bladder cancer, specifically non-muscle invasive bladder cancer (NMIBC), including urothelial carcinoma, transitional cell carcinoma, and carcinoma in situ. It is an investigational therapy given intravesically, meaning directly into the bladder, and is being studied in adults with recurrent NMIBC.
UGN-501 is being developed by UroGen Pharma Ltd., which trades under the ticker URGN. The company is running the program as an intravesically administered monoclonal antibody for bladder cancer.
UGN-501 is in Phase 1 clinical development. It is investigational and has not been approved by the FDA. The ongoing study is a Phase 1 dose-escalation trial, which is the earliest stage of human testing and is designed primarily to evaluate safety and dosing.
UGN-501 is being studied in one clinical trial, NCT07725796, titled a Phase 1 dose-escalation study of UGN-501 administered intravesically in adult participants with recurrent NMIBC. The trial is currently recruiting, is enrolling about 30 participants, and is taking place in the United States.
UGN-501 is administered intravesically, meaning it is delivered directly into the bladder rather than systemically. This route is intended to concentrate the monoclonal antibody at the site of disease in patients with non-muscle invasive bladder cancer.
The UGN-501 Phase 1 trial, NCT07725796, enrolls adults aged 18 years and older of any sex with recurrent non-muscle invasive bladder cancer. It does not enroll healthy volunteers, and the study is uncontrolled, meaning all participants receive UGN-501 without a comparator arm.