RECRUITING Phase 1 / Phase 2 ClinicalTrials.gov

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

Sponsor: Merck Sharp & Dohme LLC • ClinicalTrials.gov ID: NCT06637423

Registry updated: 2026-10-15

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Description

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.

Interventions

Sacituzumab tirumotecan (Drug)
Intravesical administration
Rescue medication (Drug)
Participants are allowed to take rescue medication for stomatitis or oral mucositis. At the discretion of the investigator, participants are provided with a prescription for rescue medications. Recommended rescue medications are antihistamine, histamine-2 (H2) receptor antagonist, acetaminophen or equivalent, dexamethasone or equivalent infusion or steroid mouthwash (dexamethasone or equivalent), antiemetic medications, oral nystatin suspension or antifungal medications, antidiarrheal agents, antiemetic agents, opiate and non-opiate analgesic agents, appetite stimulants, and granulocyte and erythroid growth factors.
Supportive care measures (Drug)
Participants are allowed to take supportive care measures for the management of adverse events associated with study intervention at the discretion of the investigator. Artificial tear drops or gel may be given as a supportive care for Ocular Surface Toxicity.

Eligibility criteria

Inclusion Criteria: 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 Exclusion Criteria: 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.

Conditions

Non-Muscle Invasive Bladder Cancer

Locations

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

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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