Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as UGN-301 (zalifrelimab) intravesical solution
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 developed by UroGen Pharma Ltd. (ticker URGN) for non-muscle invasive bladder cancer, including carcinoma in situ of the bladder and recurrent urothelial carcinoma of the bladder. It is a Phase 1 candidate and has not been approved by the FDA.
UGN-301 targets CTLA4, a protein receptor that acts as a checkpoint in immune regulation. By binding CTLA4, the drug is designed to modulate immune checkpoint activity in patients with non-muscle invasive bladder cancer. CTLA4 is a validated immuno-oncology target class.
UroGen Pharma Ltd., which trades under the ticker URGN, is developing UGN-301. The company sponsored the Phase 1 dose-escalation study of the drug in patients with recurrent non-muscle invasive bladder cancer.
UGN-301 is in Phase 1 clinical development. Its single Phase 1 dose-escalation trial in recurrent non-muscle invasive bladder cancer has been completed, and the drug remains investigational. It has not been approved by the FDA for any indication.
UGN-301 has been studied in one Phase 1 trial, NCT05375903, titled a Phase 1 dose-escalation study of UGN-301 in patients with recurrent non-muscle invasive bladder cancer. The trial enrolled 51 patients across the United States, Italy, and Spain and is now completed.
UGN-301 is being developed for non-muscle invasive bladder cancer, including carcinoma in situ of the bladder, bladder cancer, and recurrent urothelial carcinoma of the bladder. It is an investigational therapy in Phase 1 testing and is not approved for clinical use.