The goal of the study is to learn about the safety of Sacituzumab Tirumotecan and if people can tolerate it when given in the bladder and find the highest dose that people can take without having certain problems. Researchers will then choose a dose level of Sacituzumab Tirumotecan to use in future studies to learn how well the drug works.
Has recurrent low-grade (Ta) Non-Muscle Invasive Bladder Cancer (NMIBC) in the bladder
Must have visible tumor by cystoscopy within 12 weeks prior to first dose
Multiple tumors
>1 occurrence of low-grade NMIBC within 1 year of the current diagnosis at Screening
Newly diagnosed low-grade non-muscle invasive bladder cancer (Ta NMIBC) in the bladder
Past or current history of high-grade (Ta or T1 or CIS) NMIBC, muscle invasive bladder cancer (MIBC) or metastatic urothelial carcinoma (UC)
Has a condition that would prohibit normal voiding (or hold bladder voiding for 1 to 2 hours)
Has history of documented severe dry eye syndrome, severe Meibomian gland disease, and/or blepharitis, or severe corneal disease that prevents and/or delays corneal healing
Merck Sharp & Dohme LLC
Lead sponsor