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  • Cancer Type: Genitourinary
  • Study Type: Treatment
  • NCT#: NCT05316155
  • Phase: Phase I
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  • 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


    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).


    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


    Therapy (NOS)


    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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