A Phase 1 Dose-escalation Study of UGN-501 Administered Intravesically in Adult Participants With Recurrent NMIBC

Part of paid clinical trials in Queen Creek, Arizona.

Sponsor
UroGen Pharma, Inc., a subsidiary of UroGen Pharma Ltd.
Study ID
NCT07725796
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Bladder (Urothelial, Transitional Cell) Cancer
  • NMIBC
  • Non-Muscle Invasive Bladder Carcinoma
  • Non-muscle Invasive Bladder Cancer (NMIBC)
  • Urothelial Carcinoma Bladder
  • Urothelial Carcinoma Recurrent
  • Urothelial Carcinoma in Situ
  • Urothelial Carcinoma of the Urinary Bladder

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • UGN-501 — BIOLOGICAL
    UGN-501 is administered by intravesical instillation into the bladder. Participants receive 6 once-weekly instillations during the Induction Period. Participants eligible for maintenance receive 3 once-weekly instillations quarterly from Month 3 through Month 12.

Study Details

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).

Key Dates

First listed
Jul 24, 2026
Start date
Sep 30, 2026
Status verified
Jul 2026
Primary completion
Aug 2, 2029
Completion
Aug 2, 2029

Study Design

Enrollment
30 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: UGN-501 Dose Escalation (Part 1)
    Dose escalation of UGN-501 in participants with recurrent NMIBC with high grade (HG) Ta and/or T1 disease and/or CIS or recurrent low grade (LG) Ta and/or T1 disease.

Primary Outcome Measure

Incidence of dose-limiting toxicities (DLTs) and treatment-emergent adverse events (TEAEs) [ Time Frame: Up to 15 Months ]

Central Contacts

Locations (11)

FacilityCityStateZIPSite coordinators
East Valley Urology Center of ArizonaQueen CreekArizona85140
Alekya Padavala
[email protected]
480-525-7998
Harpreet Wadhwa, MD (PRINCIPAL_INVESTIGATOR)
Michael G Oefelein Clinical TrialsBakersfieldCalifornia93301
Chloe Caldasso
[email protected]
661-310-1063
Michael Oefelein, MD (PRINCIPAL_INVESTIGATOR)
Urology Center of Southern CaliforniaMurrietaCalifornia92563
Laura Guerrero
[email protected]
951-677-3000
Madhumitha Reddy, DO (PRINCIPAL_INVESTIGATOR)
Brigham and Women's HospitalBostonMassachusetts02115
Nnamdi Onnochie
[email protected]
857-221-2468
Matthew Mossanen, MD, PhD (PRINCIPAL_INVESTIGATOR)
University of Nebraska Medical CenterOmahaNebraska68198
Kacie Flaherty
[email protected]
402-559-3834
Jared Schober, MD (PRINCIPAL_INVESTIGATOR)
Ichan School of Medicine at Mount SinaiNew YorkNew York10029
Harshil Sardhara
[email protected]
908-449-1437
John Sfakianos, MD (PRINCIPAL_INVESTIGATOR)
SUNY Upstate Medical UniversitySyracuseNew York13210
Nicholas Carusone
[email protected]
315-464-5296
Joseph Jacob, MD (PRINCIPAL_INVESTIGATOR)
University of Pennsylvania-Perelman Center for Advanced MedicinePhiladelphiaPennsylvania19104
Ryan DeBarberie
[email protected]
215-615-3780
Trinity Bivalacqua, MD, PhD (PRINCIPAL_INVESTIGATOR)
START CarolinasMyrtle BeachSouth Carolina29572
[email protected]
843-839-1679
Abhishek Srivastava, MD (PRINCIPAL_INVESTIGATOR)
UPNT Research InstituteArlingtonTexas76017
Keoisha Malone
[email protected]
615-523-9624
Patrick Collini, MD (PRINCIPAL_INVESTIGATOR)
Urology AustinAustinTexas78759
Stephanie Sova
[email protected]
512-788-9688
Brian Mazzarella, MD (PRINCIPAL_INVESTIGATOR)

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East Valley Urology Center of Arizona· Queen Creek, AZMichael G Oefelein Clinical Trials· Bakersfield, CAUrology Center of Southern California· Murrieta, CABrigham and Women's Hospital· Boston, MAUniversity of Nebraska Medical Center· Omaha, NEIchan School of Medicine at Mount Sinai· New York, NY

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