Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
UGN-301 · 1 trial · 6 indications
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...
UGN-301 is an investigational small molecule being developed for the treatment of non-muscle invasive bladder cancer (NMIBC). It is intended for patients with recurrent NMIBC, including carcinoma in situ of the bladder and urothelial carcinoma. As of the latest data, UGN-301 is in Phase 1 clinical development and is not yet approved by regulatory authorities.
UGN-301 is being developed by UroGen Pharma Ltd., a biopharmaceutical company traded on NASDAQ under the ticker symbol URGN. The company is conducting clinical trials to evaluate the safety and efficacy of UGN-301 in patients with recurrent non-muscle invasive bladder cancer.
UGN-301 is currently in Phase 1 clinical development. A Phase 1 dose-escalation study has been completed, involving 51 patients with recurrent non-muscle invasive bladder cancer. The drug is investigational and has not yet received approval from the U.S. Food and Drug Administration or other regulatory bodies.
UGN-301 has been studied in a Phase 1 dose-escalation trial identified as NCT05375903. This completed trial enrolled 51 patients with recurrent non-muscle invasive bladder cancer, including those with carcinoma in situ of the bladder and urothelial carcinoma. The study was conducted in the United States, Italy, and Spain.
UGN-301 is a small molecule therapeutic, but its specific molecular target has not been disclosed in available information. The drug is being evaluated for its ability to treat recurrent non-muscle invasive bladder cancer, though the precise mechanism of action has not been publicly detailed.