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Clinical Trials in China / NCT06864169
Active, not recruiting Phase 2

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

NCT06864169 · tracked via the Priya Life Science China tracker
Sponsor
Merck Sharp & Dohme LLC
Phase
Phase 2
Started
2025-04-01
Last updated
2026-04-23

Condition(s) studied

Gastrointestinal Cancer

Investigational drug(s) / intervention(s)

Raludotatug Deruxtecan (R-DXd)

Raludotatug Deruxtecan (R-DXd): Administered via intravenous (IV) infusion.

Study 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: 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) Exclusion Criteria: 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

Primary outcome measure(s)

Trial sites (41)

FacilityCityRegionStatus
Yale New Haven Hospital ( Site 0375) New Haven Connecticut
Sibley Memorial Hospital ( Site 0372) Washington D.C. District of Columbia
Mt Sinai Comprehensive Cancer Center ( Site 0345) Miami Beach Florida
St. Vincent Healthcare Frontier Cancer Center ( Site 0347) Billings Montana
Morristown Medical Center ( Site 0349) Morristown New Jersey
University Hospitals Cleveland Medical Center ( Site 0369) Cleveland Ohio
University of Virginia Cancer Center ( Site 0365) Charlottesville Virginia
University of Wisconsin Carbone Cancer Center ( Site 0348) Madison Wisconsin
Instituto de Investigaciones Clinicas Mar del Plata ( Site 0001) Mar del Plata Buenos Aires
Nefra Medical Care - CEMIC Saavedra ( Site 0008) Buenos Aires Buenos Aires F.D.
Instituto Medico de la Fundacion Estudios Clinicos ( Site 0007) Rosario Santa Fe Province
Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0006) La Rioja Argentina
Sunnybrook Research Institute ( Site 0044) Toronto Ontario
Princess Margaret Cancer Centre ( Site 0041) Toronto Ontario
Centre Hospitalier de l'Université de Montréal ( Site 0042) Montreal Quebec
FALP ( Site 0062) Santiago Region M. de Santiago
Centro de Estudios Clínicos SAGA ( Site 0064) Santiago Region M. de Santiago
Clínica UC San Carlos de Apoquindo ( Site 0066) Santiago Region M. de Santiago
Bradfordhill ( Site 0069) Santiago Region M. de Santiago
Centre François Baclesse ( Site 0085) Caen Calvados
Institut Regional du Cancer Montpellier ( Site 0084) Montpellier Herault
Gustave Roussy ( Site 0081) Villejuif Val-de-Marne
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
Institut Català d'Oncologia (ICO) - Badalona ( Site 0222) Badalona Barcelona
Hospital Universitario Marqués de Valdecilla ( Site 0221) Santander Cantabria
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
Hôpitaux Universitaires de Genève (HUG) ( Site 0245) Geneva Canton of Geneva
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

+ 1 more sites — see the full list on the official registry below.

More Merck Sharp & Dohme LLC trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06864169 on ClinicalTrials.gov ↗ ← All trials in China