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ACTIVE NOT RECRUITING
NCT06864169
PHASE2

A Study of Raludotatug Deruxtecan (R-DXd) in People With Gastrointestinal Cancers (MK-5909-005)

Sponsor: Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

Summary

Researchers are looking for new ways to treat certain types of advanced gastrointestinal (GI) cancers. The study medicine raludotatug deruxtecan (also called MK-5909, R-DXd, or DS-6000a) is a type of medicine called an antibody-drug conjugate (ADC). An ADC attaches to a protein on cancer cells and delivers treatment to destroy those cells. The main goal of this study is to learn if the cancer responds to treatment (gets smaller or goes away).

Official title: A Phase 2 Nonrandomized, Open-label, Multisite Study to Evaluate the Safety and Efficacy of Raludotatug Deruxtecan in Participants With Gastrointestinal Cancers

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

160

Start Date

2025-04-01

Completion Date

2029-01-04

Last Updated

2026-03-04

Healthy Volunteers

No

Interventions

BIOLOGICAL

Raludotatug Deruxtecan (R-DXd)

Administered via intravenous (IV) infusion.

Locations (41)

Yale New Haven Hospital ( Site 0375)

New Haven, Connecticut, United States

Sibley Memorial Hospital ( Site 0372)

Washington D.C., District of Columbia, United States

Mt Sinai Comprehensive Cancer Center ( Site 0345)

Miami Beach, Florida, United States

St. Vincent Healthcare Frontier Cancer Center ( Site 0347)

Billings, Montana, United States

Morristown Medical Center ( Site 0349)

Morristown, New Jersey, United States

University Hospitals Cleveland Medical Center ( Site 0369)

Cleveland, Ohio, United States

University of Virginia Cancer Center ( Site 0365)

Charlottesville, Virginia, United States

University of Wisconsin Carbone Cancer Center ( Site 0348)

Madison, Wisconsin, United States

Instituto de Investigaciones Clinicas Mar del Plata ( Site 0001)

Mar del Plata, Buenos Aires, Argentina

Nefra Medical Care - CEMIC Saavedra ( Site 0008)

Buenos Aires, Buenos Aires F.D., Argentina

Instituto Medico de la Fundacion Estudios Clinicos ( Site 0007)

Rosario, Santa Fe Province, Argentina

Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0006)

La Rioja, Argentina

Sunnybrook Research Institute ( Site 0044)

Toronto, Ontario, Canada

Princess Margaret Cancer Centre ( Site 0041)

Toronto, Ontario, Canada

Centre Hospitalier de l'Université de Montréal ( Site 0042)

Montreal, Quebec, Canada

FALP ( Site 0062)

Santiago, Region M. de Santiago, Chile

Centro de Estudios Clínicos SAGA ( Site 0064)

Santiago, Region M. de Santiago, Chile

Clínica UC San Carlos de Apoquindo ( Site 0066)

Santiago, Region M. de Santiago, Chile

Bradfordhill ( Site 0069)

Santiago, Region M. de Santiago, Chile

Centre François Baclesse ( Site 0085)

Caen, Calvados, France

Institut Regional du Cancer Montpellier ( Site 0084)

Montpellier, Herault, France

Pitie Salpetriere University Hospital ( Site 0082)

Paris, Orne, France

Gustave Roussy ( Site 0081)

Villejuif, Val-de-Marne, France

Prince of Wales Hospital ( Site 0122)

Hksar, Hong Kong

Queen Mary Hospital ( Site 0121)

Hksar, Hong Kong

Institut Català d'Oncologia (ICO) - Badalona ( Site 0222)

Badalona, Barcelona, Spain

Hospital Universitario Marqués de Valdecilla ( Site 0221)

Santander, Cantabria, Spain

Hospital Clinic de Barcelona ( Site 0223)

Barcelona, Spain

Hospital General Universitario Gregorio Marañón ( Site 0225)

Madrid, Spain

Hospital Universitario Fundacion Jimenez Diaz ( Site 0224)

Madrid, Spain

Universitaetsspital Basel ( Site 0241)

Basel, Canton of Basel-City, Switzerland

Hôpitaux Universitaires de Genève (HUG) ( Site 0245)

Geneva, Canton of Geneva, Switzerland

Universitaetsspital Zuerich ( Site 0242)

Zurich, Switzerland

China Medical University Hospital ( Site 0267)

Taichung, Taiwan

Taichung Veterans General Hospital ( Site 0265)

Taichung, Taiwan

National Cheng Kung University Hospital ( Site 0263)

Tainan, Taiwan

National Taiwan University Hospital ( Site 0261)

Taipei, Taiwan

Mackay Memorial Hospital ( Site 0266)

Taipei, Taiwan

Taipei Veterans General Hospital ( Site 0262)

Taipei, Taiwan

Ramathibodi Hospital. ( Site 0282)

Bangkok, Bangkok, Thailand

Faculty of Medicine Siriraj Hospital ( Site 0281)

Bangkok, Bangkok, Thailand