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

Last updated: May 8, 2025
Sponsor: Merck Sharp & Dohme LLC
Overall Status: Active - Recruiting

Phase

2

Condition

Colorectal Cancer

Colon Cancer

Gastric Ulcers

Treatment

Raludotatug Deruxtecan (R-DXd)

Clinical Study ID

NCT06864169
5909-005
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:
May 06, 2029

Connect with a study center

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

    La Rioja, F5300COE
    Argentina

    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 7500653
    Chile

    Active - Recruiting

  • 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

    Active - Recruiting

  • Gustave Roussy ( Site 0081)

    Villejuif, Val-de-Marne 94800
    France

    Active - Recruiting

  • Prince of Wales Hospital ( Site 0122)

    Hong Kong,
    Hong Kong

    Active - Recruiting

  • Queen Mary Hospital ( Site 0121)

    Hong Kong,
    Hong Kong

    Active - Recruiting

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

    Badalona, Barcelona 08916
    Spain

    Active - Recruiting

  • Hospital Universitario Marqués de Valdecilla ( Site 0221)

    Santander, Cantabria 39008
    Spain

    Active - Recruiting

  • Hospital Clinic de Barcelona ( Site 0223)

    Barcelona, 08036
    Spain

    Active - Recruiting

  • Hospital General Universitario Gregorio Marañón ( Site 0225)

    Madrid, 28007
    Spain

    Active - Recruiting

  • Mackay Memorial Hospital ( Site 0266)

    Taipei, 104
    Taiwan

    Active - Recruiting

  • Mt Sinai Comprehensive Cancer Center ( Site 0345)

    Miami Beach, Florida 33140
    United States

    Active - Recruiting

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

    Billings, Montana 59102
    United States

    Active - Recruiting

  • University of Wisconsin Carbone Cancer Center ( Site 0348)

    Madison, Wisconsin 53792
    United States

    Active - Recruiting

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