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Gastrointestinal CancerPhase 2REJOICE-GI01NCT06864169

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

A Phase 2 study testing Raludotatug Deruxtecan (R-DXd) in people with Gastrointestinal Cancer, run by Merck Sharp & Dohme LLC at 41 sites in 10 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Gastrointestinal Cancer
What is being tested?
Raludotatug Deruxtecan (R-DXd)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
41 sitesin 10 countries
Study dates
1 Apr 2025to 4 Jan 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 11Show fewer
  • 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)

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

41 sites in 10 countries.

41 sites in 10 countries

United States8 sites

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

    Billings, Montana, 59102

  • University of Virginia Cancer Center ( Site 0365)

    Charlottesville, Virginia, 22903

  • University Hospitals Cleveland Medical Center ( Site 0369)

    Cleveland, Ohio, 44106

  • University of Wisconsin Carbone Cancer Center ( Site 0348)

    Madison, Wisconsin, 53792

  • Mt Sinai Comprehensive Cancer Center ( Site 0345)

    Miami Beach, Florida, 33140

  • Morristown Medical Center ( Site 0349)

    Morristown, New Jersey, 07960

  • Yale New Haven Hospital ( Site 0375)

    New Haven, Connecticut, 06510

  • Sibley Memorial Hospital ( Site 0372)

    Washington D.C., District of Columbia, 20016

Other trials in United States

Taiwan6 sites

  • China Medical University Hospital ( Site 0267)

    Taichung, 40447

  • Taichung Veterans General Hospital ( Site 0265)

    Taichung, 407

  • National Cheng Kung University Hospital ( Site 0263)

    Tainan, 70403

  • National Taiwan University Hospital ( Site 0261)

    Taipei, 10002

  • Mackay Memorial Hospital ( Site 0266)

    Taipei, 104

  • Taipei Veterans General Hospital ( Site 0262)

    Taipei, 112

Other trials in Taiwan

Spain5 sites

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

    Badalona, Barcelona, 08916

  • Hospital Clinic de Barcelona ( Site 0223)

    Barcelona, 08036

  • Hospital General Universitario Gregorio Marañón ( Site 0225)

    Madrid, 28007

  • Hospital Universitario Fundacion Jimenez Diaz ( Site 0224)

    Madrid, 28040

  • Hospital Universitario Marqués de Valdecilla ( Site 0221)

    Santander, Cantabria, 39008

Other trials in Spain

Argentina4 sites

  • Nefra Medical Care - CEMIC Saavedra ( Site 0008)

    Buenos Aires, Buenos Aires F.D., C1431FWO

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

    La Rioja, F5300COE

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

    Mar del Plata, Buenos Aires, B7600FZO

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

    Rosario, Santa Fe Province, S2000CEJ

Other trials in Argentina

Chile4 sites

  • FALP ( Site 0062)

    Santiago, Region M. de Santiago, 7500921

  • Centro de Estudios Clínicos SAGA ( Site 0064)

    Santiago, Region M. de Santiago, 7501010

  • Clínica UC San Carlos de Apoquindo ( Site 0066)

    Santiago, Region M. de Santiago, 7620002

  • Bradfordhill ( Site 0069)

    Santiago, Region M. de Santiago, 8420383

Other trials in Chile

France4 sites

  • Centre François Baclesse ( Site 0085)

    Caen, Calvados, 14076

  • Institut Regional du Cancer Montpellier ( Site 0084)

    Montpellier, Herault, 34298

  • Pitie Salpetriere University Hospital ( Site 0082)

    Paris, 75013

  • Gustave Roussy ( Site 0081)

    Villejuif, Val-de-Marne, 94800

Other trials in France

Canada3 sites

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

    Montreal, Quebec, H2X 3E4

  • Sunnybrook Research Institute ( Site 0044)

    Toronto, Ontario, M4N 3M5

  • Princess Margaret Cancer Centre ( Site 0041)

    Toronto, Ontario, M5G 1X6

Other trials in Canada

Switzerland3 sites

  • Universitaetsspital Basel ( Site 0241)

    Basel, Canton of Basel-City, 4031

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

    Geneva, Canton of Geneva, 1211

  • Universitaetsspital Zuerich ( Site 0242)

    Zurich, 8091

Other trials in Switzerland

Hong Kong2 sites

  • Prince of Wales Hospital ( Site 0122)

    Hksar

  • Queen Mary Hospital ( Site 0121)

    Hksar

Other trials in Hong Kong

Thailand2 sites

  • Ramathibodi Hospital. ( Site 0282)

    Bangkok, Bangkok, 10400

  • Faculty of Medicine Siriraj Hospital ( Site 0281)

    Bangkok, Bangkok, 10700

Other trials in Thailand

About this study

Official title: 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).

Being tested
Raludotatug Deruxtecan (R-DXd)
Medical subject headings
Gastrointestinal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Raludotatug Deruxtecan (R-DXd)Biological

    Also called MK-5909, DS 6000a

    Administered via intravenous (IV) infusion.

Study groups in NCT06864169
Study groupRoleWhat they receive
Raludotatug Deruxtecan (R-DXd)ExperimentalR-DXd will be administered via IV infusion.
Receives: Biological: Raludotatug Deruxtecan (R-DXd)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Approximately 15 months

Secondary outcomes (5)

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

    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.

    Measured: Up to approximately 14 months

  2. Number of Participants who Discontinue Study Treatment due to an AE

    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.

    Measured: Up to approximately 12 months

  3. Duration of Response (DOR)

    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.

    Measured: Up to approximately 49 months

  4. Progression Free Survival (PFS)

    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.

    Measured: Up to approximately 49 months

  5. Overall Survival (OS)

    OS is defined as the time from the first dose to death due to any cause.

    Measured: Up to approximately 49 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Mar 2025
  2. Study start1 Apr 2025
  3. Primary completion18 Aug 2026 (estimated)
  4. Study completion4 Jan 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06864169
Sponsor's protocol ID
5909-005
Other IDs
2024-517416-30-00, U1111-1312-2472
Acronym
REJOICE-GI01
Status last verified
Apr 2026
First submitted
3 Mar 2025
Last updated
23 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Raludotatug Deruxtecan (R-DXd) in people with Gastrointestinal Cancer, run by Merck Sharp & Dohme LLC at 41 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 41 sites in United States, Taiwan, Spain, Argentina, Chile and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) (time frame: Approximately 15 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06864169.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.

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