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

NCT ID: NCT06864169

Last Updated: 2025-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-01

Study Completion Date

2029-01-04

Brief Summary

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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).

Detailed Description

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Conditions

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Gastrointestinal Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Raludotatug Deruxtecan (R-DXd)

R-DXd will be administered via IV infusion.

Group Type EXPERIMENTAL

Raludotatug Deruxtecan (R-DXd)

Intervention Type BIOLOGICAL

Administered via intravenous (IV) infusion.

Interventions

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Raludotatug Deruxtecan (R-DXd)

Administered via intravenous (IV) infusion.

Intervention Type BIOLOGICAL

Other Intervention Names

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MK-5909 DS 6000a

Eligibility Criteria

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Inclusion Criteria

* 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

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Daiichi Sankyo

INDUSTRY

Sponsor Role collaborator

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

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Yale New Haven Hospital ( Site 0375)

New Haven, Connecticut, United States

Site Status RECRUITING

Sibley Memorial Hospital ( Site 0372)

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

Site Status RECRUITING

Mt Sinai Comprehensive Cancer Center ( Site 0345)

Miami Beach, Florida, United States

Site Status RECRUITING

St. Vincent Healthcare Frontier Cancer Center ( Site 0347)

Billings, Montana, United States

Site Status RECRUITING

Morristown Medical Center ( Site 0349)

Morristown, New Jersey, United States

Site Status RECRUITING

University Hospitals Cleveland Medical Center ( Site 0369)

Cleveland, Ohio, United States

Site Status RECRUITING

University of Virginia Cancer Center ( Site 0365)

Charlottesville, Virginia, United States

Site Status RECRUITING

University of Wisconsin Carbone Cancer Center ( Site 0348)

Madison, Wisconsin, United States

Site Status RECRUITING

Instituto de Investigaciones Clinicas Mar del Plata ( Site 0001)

Mar del Plata, Buenos Aires, Argentina

Site Status RECRUITING

Nefra Medical Care - CEMIC Saavedra ( Site 0008)

Buenos Aires, Buenos Aires F.D., Argentina

Site Status RECRUITING

Instituto Medico de la Fundacion Estudios Clinicos ( Site 0007)

Rosario, Santa Fe Province, Argentina

Site Status RECRUITING

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

La Rioja, , Argentina

Site Status RECRUITING

Sunnybrook Research Institute ( Site 0044)

Toronto, Ontario, Canada

Site Status RECRUITING

Princess Margaret Cancer Centre ( Site 0041)

Toronto, Ontario, Canada

Site Status RECRUITING

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

Montreal, Quebec, Canada

Site Status RECRUITING

FALP ( Site 0062)

Santiago, Region M. de Santiago, Chile

Site Status RECRUITING

Centro de Estudios Clínicos SAGA ( Site 0064)

Santiago, Region M. de Santiago, Chile

Site Status RECRUITING

Clínica UC San Carlos de Apoquindo ( Site 0066)

Santiago, Region M. de Santiago, Chile

Site Status RECRUITING

Bradfordhill ( Site 0069)

Santiago, Region M. de Santiago, Chile

Site Status RECRUITING

Centre François Baclesse ( Site 0085)

Caen, Calvados, France

Site Status RECRUITING

Institut Regional du Cancer Montpellier ( Site 0084)

Montpellier, Herault, France

Site Status RECRUITING

Pitie Salpetriere University Hospital ( Site 0082)

Paris, Orne, France

Site Status RECRUITING

Gustave Roussy ( Site 0081)

Villejuif, Val-de-Marne, France

Site Status RECRUITING

Prince of Wales Hospital ( Site 0122)

Hksar, , Hong Kong

Site Status RECRUITING

Queen Mary Hospital ( Site 0121)

Hksar, , Hong Kong

Site Status RECRUITING

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

Badalona, Barcelona, Spain

Site Status RECRUITING

Hospital Universitario Marqués de Valdecilla ( Site 0221)

Santander, Cantabria, Spain

Site Status RECRUITING

Hospital Clinic de Barcelona ( Site 0223)

Barcelona, , Spain

Site Status RECRUITING

Hospital General Universitario Gregorio Marañón ( Site 0225)

Madrid, , Spain

Site Status RECRUITING

Hospital Universitario Fundacion Jimenez Diaz ( Site 0224)

Madrid, , Spain

Site Status RECRUITING

Universitaetsspital Basel ( Site 0241)

Basel, Canton of Basel-City, Switzerland

Site Status RECRUITING

Hôpitaux Universitaires de Genève (HUG) ( Site 0245)

Geneva, Canton of Geneva, Switzerland

Site Status RECRUITING

Universitaetsspital Zuerich ( Site 0242)

Zurich, , Switzerland

Site Status RECRUITING

China Medical University Hospital ( Site 0267)

Taichung, , Taiwan

Site Status RECRUITING

Taichung Veterans General Hospital ( Site 0265)

Taichung, , Taiwan

Site Status RECRUITING

National Cheng Kung University Hospital ( Site 0263)

Tainan, , Taiwan

Site Status RECRUITING

National Taiwan University Hospital ( Site 0261)

Taipei, , Taiwan

Site Status RECRUITING

Mackay Memorial Hospital ( Site 0266)

Taipei, , Taiwan

Site Status RECRUITING

Taipei Veterans General Hospital ( Site 0262)

Taipei, , Taiwan

Site Status RECRUITING

Ramathibodi Hospital. ( Site 0282)

Bangkok, Bangkok, Thailand

Site Status RECRUITING

Faculty of Medicine Siriraj Hospital ( Site 0281)

Bangkok, Bangkok, Thailand

Site Status RECRUITING

Countries

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United States Argentina Canada Chile France Hong Kong Spain Switzerland Taiwan Thailand

Central Contacts

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Toll Free Number

Role: CONTACT

Phone: 1-888-577-8839

Email: [email protected]

Facility Contacts

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Related Links

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http://www.merckclinicaltrials.com

Merck Clinical Trials Information

Other Identifiers

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2024-517416-30-00

Identifier Type: OTHER

Identifier Source: secondary_id

U1111-1312-2472

Identifier Type: OTHER

Identifier Source: secondary_id

5909-005

Identifier Type: -

Identifier Source: org_study_id