Brief Title: Erdafitinib Intravesical Delivery System for Localized Bladder Cancer

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Parts 1 to 3: Number of Participants with Adverse Events (AEs)

Primary Outcome 1 - Timeframe: Up to 5 years 11 months

Primary Outcome 2 - Measure: Parts 1 to 3: Number of Participants with AEs by Severity

Primary Outcome 2 - Timeframe: Up to 5 years 11 months

Primary Outcome 3 - Measure: Part 1: Number of Participants with Dose-limiting Toxicity (DLT)

Primary Outcome 3 - Timeframe: Up to 28 days

Primary Outcome 4 - Measure: Part 4: Overall Complete Response (CR) in Participants with Intermediate Risk-Non-Muscle Invasive Bladder Cancer (IR-NMIBC)

Primary Outcome 4 - Timeframe: Up to 5 years 11 months

CONDITION

• Urinary Bladder Neoplasms
• Receptors
• Fibroblast Growth Factor

ELIGIBILITY

Inclusion Criteria:
Parts 1-3:
* Muscle-invasive or recurrent, non-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
Part 4:
* Have histologically confirmed diagnosis of recurrent Intermediate-risk-non-muscle invasive bladder cancer (IR-NMIBC) Ta LG tumors

- * Must not have undergone tumor debulking or selective ablation of visible lesions; partial tumor biopsy to confirm diagnosis and provide tissue for biomarker testing is permitted as long as remaining tumor is at least 5 millimeter (mm) in size

- * Must submit tissue and urine for FGFR testing

- * Can have a prior or concurrent second malignancy which natural history or treatment is unlikely to interfere with any study endpoints of safety or the efficacy of the study treatment
Exclusion Criteria:
Parts 1-3:
* 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
Part 4:
* Histologically confirmed diagnosis of T1 NMIBC, HR NMIBC (HG/G2 or HG/G3 or CIS) or MIBC, locally advanced, non-resectable, or metastatic urothelial carcinoma at any time prior to enrollment

- * Known allergies, hypersensitivity, or intolerance to any study component or its excipients

- * Has a current diagnosis of primary IR-NMIBC

- * Received an investigational treatment for bladder cancer after Transurethral Resection of the Bladder Tumor (TURBT) for the current NMIBC diagnosis or within 4 weeks or the agent/therapy washout period, whichever is longer, before the planned first dose of study treatment, or is currently enrolled in an investigational study

- * Evidence of current bladder perforation by cystoscopy or imaging

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: [email protected]

LOCATION