A Study of Raludotatug Deruxtecan (R-DXd) in People With Gastrointestinal Cancers (MK-5909-005)
Running, not enrolling · Phase 2
Conditions studied: Gastrointestinal Cancer
In brief
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).
Key facts
- Study ID
- NCT06864169
- Run by
- Merck Sharp & Dohme LLC
- People needed
- 160
- Starts
- 2025-04-01
- Expected to finish
- 2029-01-04
- Last updated by the study team
- 2026-04-23
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- The main inclusion criteria include but are not limited to the following:
- Has one of the following cancers:
- Unresectable or metastatic pancreatic ductal adenocarcinoma (PDAC)
- Unresectable or metastatic adenocarcinoma of the biliary tract [intra- or extrahepatic holangiocarcinoma (CCA) or gallbladder cancer (GBC)]
- Unresectable or metastatic colorectal adenocarcinoma
- Unresectable or metastatic gastric adenocarcinoma
- Gastroesophageal junction adenocarcinoma (GEJAC)
- Esophageal adenocarcinoma (EAC)
- Has received prior therapy for the cancer
- Has a life expectancy of at least 3 months
- If human immunodeficiency virus (HIV) infected, must have well controlled HIV on antiretroviral therapy (ART)
You may not qualify if…
- The main exclusion criteria include but are not limited to the following:
- Has a history of (noninfectious) interstitial lung disease (ILD)/pneumonitis that required steroids or has current ILD/pneumonitis, and/or suspected ILD/pneumonitis
- Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses
- Has uncontrolled or significant cardiovascular disease
- Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
- Active autoimmune disease that has required systemic treatment in the past 2 years
- Has not adequately recovered from major surgery or has ongoing surgical complications
- HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
Where it is running
- 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
- Gustave Roussy ( Site 0081) — Villejuif, Val-de-Marne, France
- Pitie Salpetriere University Hospital ( Site 0082) — Paris, France
- Prince of Wales Hospital ( Site 0122) — Hksar, Hong Kong
- Queen Mary Hospital ( Site 0121) — Hksar, Hong Kong
Full record on ClinicalTrials.gov
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