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30 Participants NeededMy employer runs this trial

UGN-501 for Bladder Cancer

Recruiting at 15 trial locations
HL
Overseen ByHeather Lansford
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: UroGen Pharma, Inc., a subsidiary of UroGen Pharma Ltd.
Must not be taking: Immune modulators, Intravesical therapy
Disqualifiers: Muscle invasive cancer, Systemic therapy, Immunocompromised, others
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?

This trial is for adults with recurrent non-muscle invasive bladder cancer (NMIBC) who have had certain types of tumors return after previous treatments. Participants must be generally healthy, have good organ function, and not have more advanced or metastatic bladder cancer.

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.
See 10 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction

Participants receive UGN-501 intravesically to evaluate safety, tolerability, and pharmacokinetics

12 weeks

Maintenance

Participants with no disease recurrence or complete response enter maintenance phase with assessments every 3 months

Up to 15 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

What Are the Treatments Tested in This Trial?

Interventions

  • UGN-501

Trial Overview

The study is testing different doses of UGN-501 given directly into the bladder to find a safe dose for future studies. It focuses on safety and how well people tolerate the treatment in those with recurring NMIBC.

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

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