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NCT05316155 · ClinicalTrials.gov record · last posted 2026-07-31

Study of Erdafitinib Intravesical Delivery System for Localized Bladder Cancer

StatusActive, Not Recruiting
PhasePhase 1/2
Started2022-04-11
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from the ClinicalTrials.gov record
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).

Protocol amendment history 1 change detected by DataLookout

2026-08-01
Enrollment closed, study ongoing
Trial Details
NCT Number NCT05316155
Lead Sponsor Janssen Research & Development, LLC
Conditions Non-Muscle Invasive Bladder Neoplasms
Enrollment 235 participants
Start Date 2022-04-11
Primary Completion 2028-03-30 (estimated)
Study Completion 2029-07-24 (estimated)
Updated on ClinicalTrials.gov 2026-07-31