Study of Erdafitinib Intravesical Delivery System for Localized Bladder Cancer

• Status: Not yet recruiting
• Trial end date: 2027-04-14
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study in Part 1 (dose escalation) is to determine the recommended Phase 2 dose(s) (RP2D[s]) and in Part 2 (dose expansion) is to determine the safety of Erdafitinib Intravesical Delivery System administered at the RP2D(s).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Research & Development, LLC

Criteria

Inclusion Criteria:

• Recurrent, non-muscle-invasive or muscle-invasive urothelial carcinoma of the Bladder

• Activating tumor pan-fibroblast growth factor receptor (FGFR) mutation or fusion, as determined by local or central testing, approved by the sponsor prior to the start of study treatment: Local tissue-based results (if already existing) from next-generation sequencing (NGS) or polymerase chain reaction (PCR) tests performed in Clinical Laboratory Improvement Amendments (CLIA) -certified or equivalent laboratories, or results from commercially available PCR or NGS tests

• Cohorts 1 and 2: Bacillus Calmette-Guérin (BCG) experienced, or participants with no BCG experience because BCG was not available as a treatment option in the participant's location within the previous 2 years and is currently unavailable.

• Cohort 1 only: Refuses or is not eligible for radical cystectomy (RC)

• Cohorts 2 and 4: Willing and eligible for RC

Exclusion Criteria:

• Concurrent extra-vesical (that is, urethra, ureter, renal pelvis) transitional cell carcinoma of the urothelium

• Prior treatment with an pan-fibroblast growth factor receptor (FGFR) inhibitor

• Received pelvic radiotherapy <=6 months prior to the planned start of study treatment. If received pelvic radiotherapy greater than (>)6 months prior to the start of study treatment, there must be no cystoscopic evidence of radiation cystitis

• Presence of any bladder or urethral anatomic feature that in the opinion of the investigator may prevent the safe use of Erdafitinib intravesical delivery system

• Indwelling urinary catheter. Intermittent catheterization is acceptable