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

NCT06864169 | Active Not Recruiting Phase 2 FDA Drug

• 3 other identifiers: 5909-0052024-517416-30-00U1111-1312-2472
• Study Type: interventional
• Target: 160
• Locations: 10 countries
• Sites: 41

Brief 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).

Conditions

Gastrointestinal Cancer

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. The percentage of participants who experience CR or PR as assessed by BICR will be presented.

  Approximately 15 months

Secondary Outcomes (5)

• Number of Participants who Experience One or More Adverse Events (AEs)

  Up to approximately 14 months

• Number of Participants who Discontinue Study Treatment due to an AE

  Up to approximately 12 months

• Duration of Response (DOR)

  Up to approximately 49 months

• Progression Free Survival (PFS)

  Up to approximately 49 months

• Overall Survival (OS)

  Up to approximately 49 months

Study Arms (1)

Raludotatug Deruxtecan (R-DXd)

EXPERIMENTAL

R-DXd will be administered via IV infusion.

Biological: Raludotatug Deruxtecan (R-DXd)

Interventions

Raludotatug Deruxtecan (R-DXd) BIOLOGICAL

Administered via intravenous (IV) infusion.

Also known as: MK-5909, DS 6000a

Raludotatug Deruxtecan (R-DXd)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead
• Daiichi Sankyo: collaborator

Study Sites (41)

Yale New Haven Hospital ( Site 0375)

New Haven, Connecticut, 06510, United States

Location

Sibley Memorial Hospital ( Site 0372)

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

Location

Mt Sinai Comprehensive Cancer Center ( Site 0345)

Miami Beach, Florida, 33140, United States

Location

St. Vincent Healthcare Frontier Cancer Center ( Site 0347)

Billings, Montana, 59102, United States

Location

Morristown Medical Center ( Site 0349)

Morristown, New Jersey, 07960, United States

Location

University Hospitals Cleveland Medical Center ( Site 0369)

Cleveland, Ohio, 44106, United States

Location

University of Virginia Cancer Center ( Site 0365)

Charlottesville, Virginia, 22903, United States

Location

University of Wisconsin Carbone Cancer Center ( Site 0348)

Madison, Wisconsin, 53792, United States

Location

Instituto de Investigaciones Clinicas Mar del Plata ( Site 0001)

Mar del Plata, Buenos Aires, B7600FZO, Argentina

Location

Nefra Medical Care - CEMIC Saavedra ( Site 0008)

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

Location

Instituto Medico de la Fundacion Estudios Clinicos ( Site 0007)

Rosario, Santa Fe Province, S2000CEJ, Argentina

Location

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

La Rioja, F5300COE, Argentina

Location

Sunnybrook Research Institute ( Site 0044)

Toronto, Ontario, M4N 3M5, Canada

Location

Princess Margaret Cancer Centre ( Site 0041)

Toronto, Ontario, M5G 1X6, Canada

Location

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

Montreal, Quebec, H2X 3E4, Canada

Location

FALP ( Site 0062)

Santiago, Region M. de Santiago, 7500921, Chile

Location

Centro de Estudios Clínicos SAGA ( Site 0064)

Santiago, Region M. de Santiago, 7501010, Chile

Location

Clínica UC San Carlos de Apoquindo ( Site 0066)

Santiago, Region M. de Santiago, 7620002, Chile

Location

Bradfordhill ( Site 0069)

Santiago, Region M. de Santiago, 8420383, Chile

Location

Centre François Baclesse ( Site 0085)

Caen, Calvados, 14076, France

Location

Institut Regional du Cancer Montpellier ( Site 0084)

Montpellier, Herault, 34298, France

Location

Gustave Roussy ( Site 0081)

Villejuif, Val-de-Marne, 94800, France

Location

Pitie Salpetriere University Hospital ( Site 0082)

Paris, 75013, France

Location

Prince of Wales Hospital ( Site 0122)

Hksar, Hong Kong

Location

Queen Mary Hospital ( Site 0121)

Hksar, Hong Kong

Location

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

Badalona, Barcelona, 08916, Spain

Location

Hospital Universitario Marqués de Valdecilla ( Site 0221)

Santander, Cantabria, 39008, Spain

Location

Hospital Clinic de Barcelona ( Site 0223)

Barcelona, 08036, Spain

Location

Hospital General Universitario Gregorio Marañón ( Site 0225)

Madrid, 28007, Spain

Location

Hospital Universitario Fundacion Jimenez Diaz ( Site 0224)

Madrid, 28040, Spain

Location

Universitaetsspital Basel ( Site 0241)

Basel, Canton of Basel-City, 4031, Switzerland

Location

Hôpitaux Universitaires de Genève (HUG) ( Site 0245)

Geneva, Canton of Geneva, 1211, Switzerland

Location

Universitaetsspital Zuerich ( Site 0242)

Zurich, 8091, Switzerland

Location

China Medical University Hospital ( Site 0267)

Taichung, 40447, Taiwan

Location

Taichung Veterans General Hospital ( Site 0265)

Taichung, 407, Taiwan

Location

National Cheng Kung University Hospital ( Site 0263)

Tainan, 70403, Taiwan

Location

National Taiwan University Hospital ( Site 0261)

Taipei, 10002, Taiwan

Location

Mackay Memorial Hospital ( Site 0266)

Taipei, 104, Taiwan

Location

Taipei Veterans General Hospital ( Site 0262)

Taipei, 112, Taiwan

Location

Ramathibodi Hospital. ( Site 0282)

Bangkok, Bangkok, 10400, Thailand

Location

Faculty of Medicine Siriraj Hospital ( Site 0281)

Bangkok, Bangkok, 10700, Thailand

Location

Related Links

• Merck Clinical Trials Information
• Plain Language Summary

MeSH Terms

Conditions

Gastrointestinal Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2025
• First Posted: March 7, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): August 18, 2026
• Study Completion (Estimated): January 4, 2029
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

HK (2); US (8); AR (4); TW (6); CL (4); CH (3); FR (4); CA (3); TH (2); ES (5)