Safety and Efficacy Study of Intravesical Instillation of TARA-002 in Adults With High-grade Non-muscle Invasive Bladder Cancer (ADVANCED-2)

This study is evaluating an investigational treatment called TARA-002 for adults with high-grade non-muscle invasive bladder cancer, a type of bladder cancer that has not grown into the muscle layer of the bladder. In this study, TARA-002 is given directly into the bladder through a small catheter. Participants will visit the clinic on a regular schedule for treatment and follow-up care, which may include bladder examinations, urine and blood tests, and physical exams so researchers can closely monitor health, treatment response, and any side effects.

• Adults 18+ years of age
• Diagnosed with high-grade non-muscle invasive bladder cancer (NMIBC), including carcinoma in situ (CIS) with or without Ta/T1 disease
• Must have not received BCG treatment before, or your cancer did not improve enough with prior BCG treatment
• Cannot have muscle-invasive or metastatic bladder cancer
• Cannot have upper urinary tract malignancy

• Receiving the investigational treatment placed directly into the bladder through a small catheter
• Attending scheduled treatment visits and follow-up appointments
• Have regular bladder examinations (cystoscopies), urine and blood tests, and physical exams to monitor health and check how the cancer responds to treatment