A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Patients With Bladder Cancer (MK-2870-027)

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMerck Sharp & Dohme LLC

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Sacituzumab tirumotecan
  • Rescue medication
  • Supportive care measures

Treatment groups

32 Participants
are divided into 1 treatment group

Sponsors and collaborators