UGN-501 for Bladder Cancer

Not yet recruiting at 10 trial locations
HL
Overseen ByHeather Lansford
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: UroGen Pharma, Inc., a subsidiary of UroGen Pharma Ltd.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This study is being conducted to evaluate the safety and tolerability of UGN-501 administered intravesically in adult participants with recurrent non-muscle invasive bladder cancer (NMIBC) and to determine the recommended Phase 2 dose (RP2D).

Who Is on the Research Team?

SM

Sebastian Mirkin, MD

Principal Investigator

UroGen Pharma

Are You a Good Fit for This Trial?

Inclusion Criteria

I am 18 years old or older.
My low-grade tumor is either recurring, large, multifocal, or has invaded deeper tissue.
I am able to care for myself and do light activities.
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Exclusion Criteria

I have or had advanced or metastatic urothelial carcinoma.
Any medical, psychological, familial, sociological, or geographical condition that would preclude participation per investigator opinion
I have not had another cancer in the past 5 years, except certain skin or prostate cancers.
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What Are the Treatments Tested in This Trial?

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: UGN-501 Dose Escalation (Part 1)Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

UroGen Pharma, Inc., a subsidiary of UroGen Pharma Ltd.

Lead Sponsor