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

NCT07725796 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-07-24

No results posted yet for this study

Summary

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).

Conditions

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

Interventions

BIOLOGICAL

UGN-501

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.

Sponsors & Collaborators

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

    lead INDUSTRY

Principal Investigators

  • Sebastian Mirkin, MD · UroGen Pharma

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2029-08-02
Completion
2029-08-02
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07725796 on ClinicalTrials.gov