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

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).

Trial Details

NCT ID
NCT07725796
Phase
PHASE1
Sponsor
UroGen Pharma, Inc., a subsidiary of UroGen Pharma Ltd.
Status
RECRUITING
Cancer Type
Bladder Cancer
Interventions
  • UGN-501
Locations (sample)
  • Queen Creek, Arizona, United States|33.24866,-111.6343
  • Bakersfield, California, United States|35.37329,-119.01871
  • Murrieta, California, United States|33.55391,-117.21392
  • Aurora, Colorado, United States|39.72943,-104.83192
  • Miami, Florida, United States|25.77427,-80.19366

Key Eligibility Criteria

  • Participant must be 18 years of age or older at the time of signing informed consent.
  • Has confirmed recurrent non-muscle invasive bladder cancer (NMIBC) with high-grade Ta and/or T1 disease and/or carcinoma in situ (CIS), or recurren…
  • Participants with high-grade Ta and/or T1 disease and/or CIS must meet one of the following criteria:
  • Has BCG-unresponsive disease, defined as:

For full eligibility, visit ClinicalTrials.gov.

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