A Study of Raludotatug Deruxtecan (R-DXd) in People With Gastrointestinal Cancers (MK-5909-005) (REJOICE-GI01)

April 22, 2026 updated by: Merck Sharp & Dohme LLC

A Phase 2 Nonrandomized, Open-label, Multisite Study to Evaluate the Safety and Efficacy of Raludotatug Deruxtecan in Participants With Gastrointestinal Cancers

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).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

160

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • La Rioja, Argentina, F5300COE
        • Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0006)
    • Buenos Aires
      • Mar del Plata, Buenos Aires, Argentina, B7600FZO
        • Instituto de Investigaciones Clinicas Mar del Plata ( Site 0001)
    • Buenos Aires F.D.
      • Buenos Aires, Buenos Aires F.D., Argentina, C1431FWO
        • Nefra Medical Care - CEMIC Saavedra ( Site 0008)
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina, S2000CEJ
        • Instituto Medico de la Fundacion Estudios Clinicos ( Site 0007)
  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Research Institute ( Site 0044)
      • Toronto, Ontario, Canada, M5G 1X6
        • Princess Margaret Cancer Centre ( Site 0041)
    • Quebec
      • Montreal, Quebec, Canada, H2X 3E4
        • Centre Hospitalier de l'Université de Montréal ( Site 0042)
  • Chile
    • Region M. de Santiago
      • Santiago, Region M. de Santiago, Chile, 7500921
        • FALP ( Site 0062)
      • Santiago, Region M. de Santiago, Chile, 7501010
        • Centro de Estudios Clínicos SAGA ( Site 0064)
      • Santiago, Region M. de Santiago, Chile, 7620002
        • Clínica UC San Carlos de Apoquindo ( Site 0066)
      • Santiago, Region M. de Santiago, Chile, 8420383
        • Bradfordhill ( Site 0069)
  • France
      • Paris, France, 75013
        • Pitie Salpetriere University Hospital ( Site 0082)
    • Calvados
      • Caen, Calvados, France, 14076
        • Centre François Baclesse ( Site 0085)
    • Herault
      • Montpellier, Herault, France, 34298
        • Institut Regional du Cancer Montpellier ( Site 0084)
    • Val-de-Marne
      • Villejuif, Val-de-Marne, France, 94800
        • Gustave Roussy ( Site 0081)
  • Hong Kong
      • Hksar, Hong Kong
        • Prince of Wales Hospital ( Site 0122)
      • Hksar, Hong Kong
        • Queen Mary Hospital ( Site 0121)
  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinic de Barcelona ( Site 0223)
      • Madrid, Spain, 28007
        • Hospital General Universitario Gregorio Marañón ( Site 0225)
      • Madrid, Spain, 28040
        • Hospital Universitario Fundacion Jimenez Diaz ( Site 0224)
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Institut Català d'Oncologia (ICO) - Badalona ( Site 0222)
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Hospital Universitario Marqués de Valdecilla ( Site 0221)
  • Switzerland
      • Zurich, Switzerland, 8091
        • Universitaetsspital Zuerich ( Site 0242)
    • Canton of Basel-City
      • Basel, Canton of Basel-City, Switzerland, 4031
        • Universitaetsspital Basel ( Site 0241)
    • Canton of Geneva
      • Geneva, Canton of Geneva, Switzerland, 1211
        • Hôpitaux Universitaires de Genève (HUG) ( Site 0245)
  • Taiwan
      • Taichung, Taiwan, 40447
        • China Medical University Hospital ( Site 0267)
      • Taichung, Taiwan, 407
        • Taichung Veterans General Hospital ( Site 0265)
      • Tainan, Taiwan, 70403
        • National Cheng Kung University Hospital ( Site 0263)
      • Taipei, Taiwan, 10002
        • National Taiwan University Hospital ( Site 0261)
      • Taipei, Taiwan, 104
        • Mackay Memorial Hospital ( Site 0266)
      • Taipei, Taiwan, 112
        • Taipei Veterans General Hospital ( Site 0262)
  • Thailand
    • Bangkok
      • Bangkok, Bangkok, Thailand, 10400
        • Ramathibodi Hospital. ( Site 0282)
      • Bangkok, Bangkok, Thailand, 10700
        • Faculty of Medicine Siriraj Hospital ( Site 0281)
  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale New Haven Hospital ( Site 0375)
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20016
        • Sibley Memorial Hospital ( Site 0372)
    • Florida
      • Miami Beach, Florida, United States, 33140
        • Mt Sinai Comprehensive Cancer Center ( Site 0345)
    • Montana
      • Billings, Montana, United States, 59102
        • St. Vincent Healthcare Frontier Cancer Center ( Site 0347)
    • New Jersey
      • Morristown, New Jersey, United States, 07960
        • Morristown Medical Center ( Site 0349)
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Cleveland Medical Center ( Site 0369)
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • University of Virginia Cancer Center ( Site 0365)
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin Carbone Cancer Center ( Site 0348)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Raludotatug Deruxtecan (R-DXd)
R-DXd will be administered via IV infusion.
Biological: Raludotatug Deruxtecan (R-DXd)
Administered via intravenous (IV) infusion.
Other Names:
  • MK-5909
  • DS 6000a

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR)
Time Frame: Approximately 15 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants who Experience One or More Adverse Events (AEs)
Time Frame: Up to approximately 14 months
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be reported.
Up to approximately 14 months
Number of Participants who Discontinue Study Treatment due to an AE
Time Frame: Up to approximately 12 months
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study treatment due to an AE will be reported.
Up to approximately 12 months
Duration of Response (DOR)
Time Frame: Up to approximately 49 months
For participants who demonstrate a confirmed 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, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR as assessed by BICR will be presented.
Up to approximately 49 months
Progression Free Survival (PFS)
Time Frame: Up to approximately 49 months
PFS is defined as the time from first day of study intervention to the first documented progressive disease (PD) or death due to any cause, whichever occurs first as assessed by BICR. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. The appearance of one or more new lesions is also considered PD. PFS as assessed by BICR will be presented.
Up to approximately 49 months
Overall Survival (OS)
Time Frame: Up to approximately 49 months
OS is defined as the time from the first dose to death due to any cause.
Up to approximately 49 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Collaborators

Daiichi Sankyo

Investigators

  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2025

Primary Completion (Estimated)

August 18, 2026

Study Completion (Estimated)

January 4, 2029

Study Registration Dates

First Submitted

March 3, 2025

First Submitted That Met QC Criteria

March 3, 2025

First Posted (Actual)

March 7, 2025

Study Record Updates

Last Update Posted (Actual)

April 23, 2026

Last Update Submitted That Met QC Criteria

April 22, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5909-005
  • U1111-1312-2472 (Other Identifier: UTN)
  • 2024-517416-30-00 (Other Identifier: EU CT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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