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Brief Title: Erdafitinib Intravesical Delivery System for Localized Bladder Cancer

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

INTRODUCTION

  • Org Study ID: CR109115
  • Secondary ID: N/A
  • NCT ID: NCT05316155
  • Sponsor: Janssen Research & Development, LLC

BRIEF 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).

DETAILED DESCRIPTION

Bladder cancer is the most common malignancy worldwide where non-muscle invasive (NMIBC), requiring intensive regimens of frequent monitoring, local resection (transurethral resection of bladder [TURBT]). This study enrolls participants with non-muscle invasive or muscle invasive bladder cancer with activating fibroblast growth factor receptor (FGFR) mutations or fusions. Erdafitinib is a pan-FGFR inhibitor with demonstrated clinical activity when administered orally in patients with solid tumors, including bladder cancer, with FGFR genetic alterations. The Erdafitinib intravesical delivery system is designed to provide release of Erdafitinib in the bladder to treat localized bladder cancer, while reducing systemic toxicities. The study consists of a screening phase, a treatment phase, and a follow-up phase. Total duration of the study is 5 years 3 months.

  • Overall Status
    Recruiting
  • Start Date
    April 11, 2022
  • Phase
    Phase 1
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure:

Primary Outcome 1 - Timeframe: N/A

CONDITION

  • Urinary Bladder Neoplasms
  • Receptors
  • Fibroblast Growth Factor

ELIGIBILITY

Inclusion Criteria:
* Recurrent, non-muscle-invasive or 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, 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
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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Janssen Research & Development, LLC Clinical Trial

Role: Study Director

Affiliation: Janssen Research & Development, LLC

Overall Contact

Name: Study Contact

Phone: 844-434-4210

Email: Participate-In-This-Study@its.jnj.com

LOCATION

Facility Status Contact
Facility: University of Southern California
Los Angeles, California 90033
United States 		Status: Recruiting Contact: N/A
Facility: H. Lee Moffitt Cancer Center
Tampa, Florida 33612
United States 		Status: Recruiting Contact: N/A
Facility: Northwestern University
Chicago, Illinois 60611
United States 		Status: Recruiting Contact: N/A
Facility: Levine Cancer Institute, Carolinas HealthCare System
Charlotte, North Carolina 28204
United States 		Status: Recruiting Contact: N/A
Facility: Carolina Urologic Research Center
Myrtle Beach, South Carolina 29572
United States 		Status: Recruiting Contact: N/A
Facility: Urology Associates
Nashville, Tennessee 37209
United States 		Status: Recruiting Contact: N/A
Facility: Urology San Antonio Research
San Antonio, Texas 78229
United States 		Status: Recruiting Contact: N/A

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