NCT06331299

A Phase 3 Study of UGN-103 for Treatment of Patients With Low-grade Intermediate-risk Non-muscle Invasive Bladder Cancer

A Phase 3, Single-arm, Multicenter Study to Evaluate the Efficacy and Safety of UGN-103, a Novel Formulation of UGN-102, for the Treatment of Patients With Low-grade (LG) Non-muscle Invasive Bladder Cancer (NMIBC) at Intermediate-risk (IR) of Recurrence

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 99 (actual)
• Sponsor: UroGen Pharma Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This Phase 3, single-arm, multicenter study will evaluate the efficacy and safety of UGN-103, a novel formulation of UGN-102, instilled in the urinary bladder of patients with low-grade non-muscle invasive bladder cancer (LG-NMIBC).

Detailed description

Eligible patients will be treated with UGN-103 once weekly for 6 weeks (a total of 6 doses). Efficacy will be assessed by the complete response rate (CRR) at the 3-month Visit (approximately 3 months after the first instillation). Response will be determined based on visual observation (white light cystoscopy), histopathology of any remaining or new lesions by central pathology lab (if applicable), and interpretation of urine cytology by central pathology lab. Patients who have a complete response (CR) at the 3-month Visit, defined as having no detectable disease (NDD) in the bladder, will enter the Follow-up Period of the study. During the Follow-up Period, patients will return to the clinic every 3 months for evaluation of response. Patients will remain on study until disease recurrence, disease progression, death, or the last patient completes 12 months of follow-up (ie, 12 months after the 3-month Visit), whichever occurs first. Patients who have a non-complete response (NCR) at the 3-month Visit will undergo investigator designated standard of care (SOC) and have a separate End of Study (EOS) Visit performed.

Conditions

• Bladder Cancer
• Urothelial Carcinoma
• Urothelial Carcinoma Bladder

Interventions

Type	Name	Description
DRUG	UGN-103	UGN-103 consists of mitomycin and sterile hydrogel (a proprietary thermally responsive gel) that is used to reconstitute mitomycin before instillation. The reverse thermal properties of UGN-103 allow for local administration of mitomycin as a liquid under chilled conditions, with subsequent conversion to a semi-solid gel depot following instillation into the bladder.

Timeline

• Start date: 2024-08-29
• Primary completion: 2025-09-11
• Completion: 2026-09-01
• First posted: 2024-03-26
• Last updated: 2026-01-15

Locations

48 sites across 7 countries: United States, Bulgaria, Estonia, Georgia, Latvia, Romania, Spain

Regulatory

• FDA-regulated drug study