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

Last updated: September 15, 2025
Sponsor: Merck Sharp & Dohme LLC
Overall Status: Active - Recruiting

Phase

2

Condition

Colon Cancer

Gastric Ulcers

Abdominal Cancer

Treatment

Raludotatug Deruxtecan (R-DXd)

Clinical Study ID

NCT06864169
5909-005
2024-517416-30-00
2024-517416-30
U1111-1312-2472
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

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- orextrahepatic 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 onantiretroviral therapy (ART)

Exclusion

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

  • Has a history of (noninfectious) interstitial lung disease (ILD)/pneumonitis thatrequired steroids or has current ILD/pneumonitis, and/or suspected ILD/pneumonitis

  • Has clinically severe pulmonary compromise resulting from intercurrent pulmonaryillnesses

  • Has uncontrolled or significant cardiovascular disease

  • Has a known additional malignancy that is progressing or has required activetreatment within the past 3 years

  • Has known active central nervous system (CNS) metastases and/or carcinomatousmeningitis

  • Active autoimmune disease that has required systemic treatment in the past 2 years

  • Has not adequately recovered from major surgery or has ongoing surgicalcomplications

  • HIV-infected participants with a history of Kaposi's sarcoma and/or MulticentricCastleman's Disease

Study Design

Total Participants: 160
Treatment Group(s): 1
Primary Treatment: Raludotatug Deruxtecan (R-DXd)
Phase: 2
Study Start date:
April 01, 2025
Estimated Completion Date:
January 04, 2029

Connect with a study center

  • Instituto de Investigaciones Clinicas Mar del Plata ( Site 0001)

    Mar del plata, Buenos Aires B7600FZO
    Argentina

    Site Not Available

  • Instituto de Investigaciones Clinicas Mar del Plata ( Site 0001)

    Mar del Plata 3430863, Buenos Aires 3435907 B7600FZO
    Argentina

    Active - Recruiting

  • Nefra Medical Care - CEMIC Saavedra ( Site 0008)

    Buenos Aires 3435910, Buenos Aires F.D. 3433955 C1431FWO
    Argentina

    Active - Recruiting

  • Nefra Medical Care - CEMIC Saavedra ( Site 0008)

    Ciudad Autonoma de Buenos Aires, Caba C1431FWO
    Argentina

    Site Not Available

  • Instituto Medico de la Fundacion Estudios Clinicos ( Site 0007)

    Rosario., Santa Fe S2000CEJ
    Argentina

    Site Not Available

  • Instituto Medico de la Fundacion Estudios Clinicos ( Site 0007)

    Rosario 3838583, Santa Fe Province 3836276 S2000CEJ
    Argentina

    Active - Recruiting

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

    La Rioja, F5300COE
    Argentina

    Site Not Available

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

    La Rioja 3848950, F5300COE
    Argentina

    Active - Recruiting

  • Sunnybrook Research Institute ( Site 0044)

    Toronto, Ontario M4N 3M5
    Canada

    Site Not Available

  • Princess Margaret Cancer Centre ( Site 0041)

    Toronto 6167865, Ontario 6093943 M5G 1X6
    Canada

    Active - Recruiting

  • Sunnybrook Research Institute ( Site 0044)

    Toronto 6167865, Ontario 6093943 M4N 3M5
    Canada

    Active - Recruiting

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

    Montreal, Quebec H2X 3E4
    Canada

    Site Not Available

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

    Montreal 6077243, Quebec 6115047 H2X 3E4
    Canada

    Active - Recruiting

  • Bradfordhill ( Site 0069)

    Santiago, Region M. De Santiago 8420383
    Chile

    Active - Recruiting

  • Centro de Estudios Clínicos SAGA ( Site 0064)

    Santiago, Region M. De Santiago 7501010
    Chile

    Site Not Available

  • Clínica UC San Carlos de Apoquindo ( Site 0066)

    Santiago, Region M. De Santiago 7620002
    Chile

    Active - Recruiting

  • FALP ( Site 0062)

    Santiago., Region M. De Santiago 7500921
    Chile

    Site Not Available

  • Bradfordhill ( Site 0069)

    Santiago 3871336, Region M. de Santiago 8420383
    Chile

    Active - Recruiting

  • Centro de Estudios Clínicos SAGA ( Site 0064)

    Santiago 3871336, Region M. de Santiago 7501010
    Chile

    Active - Recruiting

  • Clínica UC San Carlos de Apoquindo ( Site 0066)

    Santiago 3871336, Region M. de Santiago 7620002
    Chile

    Active - Recruiting

  • FALP ( Site 0062)

    Santiago 3871336, Region M. de Santiago 7500921
    Chile

    Active - Recruiting

  • Centre François Baclesse ( Site 0085)

    Caen 3029241, Calvados 14076
    France

    Active - Recruiting

  • Institut Regional du Cancer Montpellier ( Site 0084)

    Montpellier, Herault 34298
    France

    Site Not Available

  • Institut Regional du Cancer Montpellier ( Site 0084)

    Montpellier 2992166, Herault 34298
    France

    Active - Recruiting

  • Pitie Salpetriere University Hospital ( Site 0082)

    Paris, Orne 75013
    France

    Site Not Available

  • Pitie Salpetriere University Hospital ( Site 0082)

    Paris 2988507, Orne 75013
    France

    Active - Recruiting

  • Gustave Roussy ( Site 0081)

    Villejuif, Val-de-Marne 94800
    France

    Site Not Available

  • Gustave Roussy ( Site 0081)

    Villejuif 2968705, Val-de-Marne 94800
    France

    Active - Recruiting

  • Prince of Wales Hospital ( Site 0122)

    Hong Kong,
    Hong Kong

    Site Not Available

  • Queen Mary Hospital ( Site 0121)

    Hong Kong,
    Hong Kong

    Active - Recruiting

  • Prince of Wales Hospital ( Site 0122)

    Hong Kong 1819729,
    Hong Kong

    Active - Recruiting

  • Queen Mary Hospital ( Site 0121)

    Hong Kong 1819729,
    Hong Kong

    Active - Recruiting

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

    Badalona, Barcelona 08916
    Spain

    Site Not Available

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

    Badalona 3129028, Barcelona 08916
    Spain

    Active - Recruiting

  • Hospital Universitario Marqués de Valdecilla ( Site 0221)

    Santander, Cantabria 39008
    Spain

    Site Not Available

  • Hospital Universitario Marqués de Valdecilla ( Site 0221)

    Santander 3109718, Cantabria 3336898 39008
    Spain

    Active - Recruiting

  • Hospital Clinic de Barcelona ( Site 0223)

    Barcelona, 08036
    Spain

    Site Not Available

  • Hospital Clinic de Barcelona ( Site 0223)

    Barcelona 3128760, 08036
    Spain

    Active - Recruiting

  • Hospital General Universitario Gregorio Marañón ( Site 0225)

    Madrid, 28007
    Spain

    Active - Recruiting

  • Hospital Universitario Fundacion Jimenez Diaz ( Site 0224)

    Madrid, 28040
    Spain

    Site Not Available

  • Hospital General Universitario Gregorio Marañón ( Site 0225)

    Madrid 3117735, 28007
    Spain

    Active - Recruiting

  • Hospital Universitario Fundacion Jimenez Diaz ( Site 0224)

    Madrid 3117735, 28040
    Spain

    Active - Recruiting

  • Universitaetsspital Basel ( Site 0241)

    Basel, Basel-Stadt 4031
    Switzerland

    Site Not Available

  • Universitaetsspital Basel ( Site 0241)

    Basel 2661604, Canton of Basel-City 2661602 4031
    Switzerland

    Active - Recruiting

  • Hôpitaux Universitaires de Genève (HUG) ( Site 0245)

    Geneva 2660646, Canton of Geneva 2660645 1211
    Switzerland

    Active - Recruiting

  • Hôpitaux Universitaires de Genève (HUG) ( Site 0245)

    Geneva, Geneve 1211
    Switzerland

    Site Not Available

  • Universitaetsspital Zuerich ( Site 0242)

    Zurich, 8091
    Switzerland

    Site Not Available

  • Universitaetsspital Zuerich ( Site 0242)

    Zurich 2657896, 8091
    Switzerland

    Active - Recruiting

  • China Medical University Hospital ( Site 0267)

    Taichung, 40447
    Taiwan

    Site Not Available

  • Taichung Veterans General Hospital ( Site 0265)

    Taichung, 407
    Taiwan

    Active - Recruiting

  • China Medical University Hospital ( Site 0267)

    Taichung 1668399, 40447
    Taiwan

    Active - Recruiting

  • Taichung Veterans General Hospital ( Site 0265)

    Taichung 1668399, 407
    Taiwan

    Active - Recruiting

  • National Cheng Kung University Hospital ( Site 0263)

    Tainan, 70403
    Taiwan

    Site Not Available

  • National Cheng Kung University Hospital ( Site 0263)

    Tainan City 1668355, 70403
    Taiwan

    Active - Recruiting

  • Mackay Memorial Hospital ( Site 0266)

    Taipei, 104
    Taiwan

    Active - Recruiting

  • National Taiwan University Hospital ( Site 0261)

    Taipei, 10002
    Taiwan

    Site Not Available

  • Taipei Veterans General Hospital ( Site 0262)

    Taipei, 112
    Taiwan

    Active - Recruiting

  • Mackay Memorial Hospital ( Site 0266)

    Taipei 1668341, 104
    Taiwan

    Active - Recruiting

  • National Taiwan University Hospital ( Site 0261)

    Taipei 1668341, 10002
    Taiwan

    Active - Recruiting

  • Taipei Veterans General Hospital ( Site 0262)

    Taipei 1668341, 112
    Taiwan

    Active - Recruiting

  • Faculty of Medicine Siriraj Hospital ( Site 0281)

    Bangkok 1609350, Bangkok 1609348 10700
    Thailand

    Active - Recruiting

  • Ramathibodi Hospital. ( Site 0282)

    Bangkok 1609350, Bangkok 1609348 10400
    Thailand

    Active - Recruiting

  • Faculty of Medicine Siriraj Hospital ( Site 0281)

    Bangkok, Krung Thep Maha Nakhon 10700
    Thailand

    Active - Recruiting

  • Ramathibodi Hospital. ( Site 0282)

    Bangkok, Krung Thep Maha Nakhon 10400
    Thailand

    Site Not Available

  • Yale New Haven Hospital ( Site 0375)

    New Haven, Connecticut 06510
    United States

    Site Not Available

  • Yale New Haven Hospital ( Site 0375)

    New Haven 4839366, Connecticut 4831725 06510
    United States

    Active - Recruiting

  • Sibley Memorial Hospital ( Site 0372)

    Washington, District of Columbia 20016
    United States

    Site Not Available

  • Sibley Memorial Hospital ( Site 0372)

    Washington D.C. 4140963, District of Columbia 4138106 20016
    United States

    Active - Recruiting

  • Mt Sinai Comprehensive Cancer Center ( Site 0345)

    Miami Beach, Florida 33140
    United States

    Site Not Available

  • Mt Sinai Comprehensive Cancer Center ( Site 0345)

    Miami Beach 4164143, Florida 4155751 33140
    United States

    Active - Recruiting

  • St. Vincent Healthcare Frontier Cancer Center ( Site 0347)

    Billings, Montana 59102
    United States

    Site Not Available

  • St. Vincent Healthcare Frontier Cancer Center ( Site 0347)

    Billings 5640350, Montana 5667009 59102
    United States

    Active - Recruiting

  • Morristown Medical Center ( Site 0349)

    Morristown, New Jersey 07960
    United States

    Site Not Available

  • Morristown Medical Center ( Site 0349)

    Morristown 5101427, New Jersey 5101760 07960
    United States

    Active - Recruiting

  • University Hospitals Cleveland Medical Center ( Site 0369)

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • University Hospitals Cleveland Medical Center ( Site 0369)

    Cleveland 5150529, Ohio 5165418 44106
    United States

    Active - Recruiting

  • University of Virginia Cancer Center ( Site 0365)

    Charlottesville, Virginia 22903
    United States

    Site Not Available

  • University of Virginia Cancer Center ( Site 0365)

    Charlottesville 4752031, Virginia 6254928 22903
    United States

    Active - Recruiting

  • University of Wisconsin Carbone Cancer Center ( Site 0348)

    Madison, Wisconsin 53792
    United States

    Site Not Available

  • University of Wisconsin Carbone Cancer Center ( Site 0348)

    Madison 5261457, Wisconsin 5279468 53792
    United States

    Active - Recruiting

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