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

Active:	Yes
Cancer Type:	Bladder Cancer Unknown Primary	NCT ID:	NCT06331299
Trial Phases:	Phase III	Protocol IDs:	BL013 (primary) NCI-2025-00695
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	UroGen Pharma Ltd.
NCI Full Details:	http://clinicaltrials.gov/show/NCT06331299

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).

Objectives

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, 15 months
after the first instillation), 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.

Treatment Sites in Georgia

Peachtree Clinical Solutions
5077 Dallas Highway
Suite 315
Powder Springs, GA 30127
(404) 905-7098

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