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Chemotherapy

UGN-103 for Bladder Cancer (UTOPIA Trial)

Phase 3
Recruiting
Research Sponsored by UroGen Pharma Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Presence of multiple tumors.
Solitary tumor > 3 cm.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 21 months
Awards & highlights

Summary

" This trial will test a new treatment called UGN-103 for patients with a certain type of bladder cancer. The study will look at how well the treatment works and if it is safe for patients

Who is the study for?
This trial is for patients with a type of bladder cancer called low-grade non-muscle invasive bladder cancer (LG-NMIBC). Participants must have had at least one prior episode, may have multiple tumors or a tumor larger than 3 cm, and should show signs of early or frequent recurrence. They need normal blood counts and no high-grade disease in recent tests. Patients must consent to follow the study rules.
What is being tested?
The trial is testing UGN-103, which is an updated version of UGN-102. It's given as a treatment directly into the bladder for those with LG-NMIBC. The goal is to see how effective and safe this new formulation is when used by itself in patients.
What are the potential side effects?
Specific side effects are not listed here but typically, treatments instilled in the bladder can cause discomfort during urination, increased frequency or urgency to urinate, possible blood in urine, and risk of urinary tract infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have more than one tumor.
Select...
My tumor is larger than 3 cm.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 21 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 21 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Complete response rate (CRR)
Secondary outcome measures
Durable complete response (DCR) rate
Duration of response (DOR)
Incidence of treatment-emergent adverse events (TEAEs), serious TEAEs, TEAEs of special interest, and abnormal clinical laboratory test results (hematology and serum chemistry)
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: UGN-103Experimental Treatment1 Intervention
Patients will receive UGN-103 (75 mg mitomycin) once weekly for 6 weeks (a total of 6 doses).

Find a Location

Who is running the clinical trial?

UroGen Pharma Ltd.Lead Sponsor
18 Previous Clinical Trials
1,241 Total Patients Enrolled
Sunil Raju, MBBSStudy DirectorUroGen Pharma
2 Previous Clinical Trials
68 Total Patients Enrolled
~58 spots leftby Mar 2025
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