Clinical Trial 22349

• Overview

  Study Title:

  Phase 1 Study of Erdafitinib Intravesical Delivery System (TAR-210) in Participants with Non-Muscle-Invasive or Muscle-Invasive Bladder Cancer and Selected FGFR Mutations or Fusions

  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).

  Objective:

  Primary Objectives: Part 1 (dose escalation): To determine the recommended Phase 2 dose(s) (RP2D[s]) for TAR-210. Part 2 (dose expansion): To determine the safety of TAR-210 administered at the RP2D(s) for up to 12 months. Secondary Objectives: To assess the PK. To assess preliminary clinical activity.

• Treatments

  Therapies:

  Therapy (NOS)

  Medications:

  JNJ-42756493 (Erdafitinib)

• Inclusion 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. Participants who received an abbreviated course of BCG due to toxicity are still eligible.
  • Cohort 1 only: Refuses or is not eligible for radical cystectomy (RC)
  • Cohorts 2 and 4: Willing and eligible for RC
  • Other criteria may apply.

• Exclusion Criteria

  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 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
  • Other exclusions may apply.

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