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

Recruiting now · Phase 1/Phase 2

Conditions studied: Non-Muscle Invasive Bladder Cancer

In brief

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.

Key facts

Study ID

NCT06637423

Run by

Merck Sharp & Dohme LLC

People needed

32

Starts

2024-12-20

Expected to finish

2029-03-14

Last updated by the study team

2026-07-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• The key exclusion criteria include but are not limited to the following:
• 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
• Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease (eg, Chron's disease, ulcerative colitis, or chronic diarrhea)
• Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
• Known additional malignancy that is progressing or has required active treatment within the past 3 years
• History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.

Where it is running

• Michael G Oefelein Clinical Trials ( Site 0053) — Bakersfield, California, United States (enrolling)
• Moffitt Cancer Center ( Site 0057) — Tampa, Florida, United States (enrolling)
• Northwestern University ( Site 0051) — Chicago, Illinois, United States (enrolling)
• Johns Hopkins University ( Site 0055) — Baltimore, Maryland, United States (enrolling)
• Princess Margaret Cancer Centre ( Site 0003) — Toronto, Ontario, Canada (enrolling)
• Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Univer ( Site 0002) — Sherbrooke, Quebec, Canada (enrolling)
• Hospital Universitario Virgen de la Victoria ( Site 0043) — Málaga, Andalusia, Spain (enrolling)
• Hospital Universitario 12 de Octubre ( Site 0042) — Madrid, Spain (enrolling)
• St Bartholomew s Hospital ( Site 0061) — London, London, City of, United Kingdom (enrolling)
• Erasmus Medisch Centrum ( Site 0032) — Rotterdam, South Holland, Netherlands (enrolling)
• Hôpital Claude Huriez ( Site 0012) — Lille, Nord, France
• HENRI MONDOR HOSPITAL ( Site 0011) — Créteil, Val-de-Marne, France
• Gustave Roussy ( Site 0013) — Villejuif, Val-de-Marne, France

Full record on ClinicalTrials.gov

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