Study of Erdafitinib Intravesical Delivery System for Localized Bladder Cancer

The purpose of the study in Part 1 (dose escalation) and in Part 2 (dose expansion) is to determine the recommended Phase 2 dose(s) (RP2D\[s\]) and evaluate preliminary clinical efficacy. Part 3 (dose expansion) will confirm safety and preliminary clinical activity at the RP2D. Part 4 (RP2D expansion; MoonRISe-2) will assess the overall complete response (CR) in participants with intermediate-risk-non-muscle invasive bladder cancer (IR-NMIBC; means the cancer cells are only in the bladder's inner lining).

Trial Details

NCT ID
NCT05316155
Phase
PHASE1 / PHASE2
Sponsor
Janssen Research & Development, LLC
Status
RECRUITING
Cancer Type
Non-Muscle-Invasive Bladder Cancer
Interventions
  • Erdafitinib Intravesical Delivery System
Locations (sample)
  • Birmingham, Alabama, United States|33.52066,-86.80249
  • Los Angeles, California, United States|34.05223,-118.24368
  • Lone Tree, Colorado, United States|39.55171,-104.8863
  • Hialeah, Florida, United States|25.8576,-80.27811
  • Largo, Florida, United States|27.90979,-82.78842

Key Eligibility Criteria

  • Parts 1-3:
  • Muscle-invasive or recurrent, non-muscle-invasive urothelial carcinoma of the bladder
  • For selected Cohorts: Activating tumor pan-fibroblast growth factor receptor (FGFR) mutation or fusion, as determined by local or central testing, …
  • Cohorts 1 and 2: Bacillus Calmette-Guérin (BCG) experienced, or participants with no BCG experience because BCG was not available as a treatment op…

For full eligibility, visit ClinicalTrials.gov.

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