Study of Erdafitinib Intravesical Delivery System for Localized Bladder Cancer

Exclusion Criteria

• •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
• •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. Previous high grade (HG) disease is accepted as long as diagnosis date is greater than or equal to (\>=5) years ago and there is documentation of low grade (LG) Ta thereafter
• •Known allergies, hypersensitivity, or intolerance to any study component or its excipients
• •Has a current diagnosis of newly diagnosed 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