A Phase 1/2 Open-label Clinical Study to Evaluate the Safety and Efficacy of Intravesical Sacituzumab Tirumotecan (Sac-TMT, MK-2870) in Participants With Intermediate-risk Non-muscle Invasive Bladder Cancer (NMIBC)
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.
∙ The key inclusion criteria include but are not limited to the following:
• 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
• Has intermediate-risk NMIBC defined as 1 or more of the following risk factors:
‣ Multiple tumors
⁃ \>1 occurrence of low-grade NMIBC within 1 year of the current diagnosis at Screening
⁃ Early recurrence (\<1 year) of the initial diagnosis of low-grade disease
⁃ Solitary tumor \>3 cm
⁃ Failure of prior intravesical treatment
• An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 assessed within 14 days prior to first dose