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NCT06637423PHASE1, PHASE2Recruiting

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

Merck Sharp & Dohme LLC

Start Date

12/20/2024

Completion Date

3/14/2029

Summary

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

Age Range: 18 years to No maximum

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.

Interventions

DRUG

Sacituzumab tirumotecan

DRUG

Rescue medication

DRUG

Supportive care measures

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Conditions

Non-Muscle Invasive Bladder Cancer

Locations

Michael G Oefelein Clinical Trials ( Site 0053)

Bakersfield, California 93301

United States

Moffitt Cancer Center ( Site 0057)

Tampa, Florida 33612

United States

Northwestern University ( Site 0051)

Chicago, Illinois 60611

United States

Johns Hopkins University ( Site 0055)

Baltimore, Maryland 21287

United States

Princess Margaret Cancer Centre ( Site 0003)

Toronto, Ontario M5G 2M9

Canada

Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Univer ( Site 0002)

Sherbrooke, Quebec J1H 5N4

Canada

Hôpital Claude Huriez ( Site 0012)

Lille, Nord 59037

France

HENRI MONDOR HOSPITAL ( Site 0011)

Créteil, Val-de-Marne 94010

France

Gustave Roussy ( Site 0013)

Villejuif, Val-de-Marne 94805

France

Erasmus Medisch Centrum ( Site 0032)

Rotterdam, South Holland 3015 GD

Netherlands

Hospital Universitario Virgen de la Victoria ( Site 0043)

Málaga, Andalusia 29010

Spain

Hospital Universitario 12 de Octubre ( Site 0042)

Madrid, 28041

Spain

St Bartholomew s Hospital ( Site 0061)

London, London, City of EC1A 7BE

United Kingdom