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New drug aims to shrink hard-to-treat GI tumors

NCT ID NCT06864169

Disease control Sponsor: Merck Sharp & Dohme LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new medicine called raludotatug deruxtecan in about 160 adults with advanced gastrointestinal cancers (pancreatic, bile duct, gallbladder, colorectal, stomach, or gastroesophageal junction). The drug is designed to attach to cancer cells and deliver a treatment that destroys them. The main goal is to see if the tumors shrink or disappear. Participants will be monitored for side effects and how long the response lasts.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 160 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2025

Expected to finish

Jan 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

cholangiocarcinoma colorectal adenocarcinoma digestive system cancer digestive system neoplasm esophageal adenocarcinoma gallbladder cancer gastric adenocarcinoma gastroesophageal junction adenocarcinoma pancreatic ductal adenocarcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Gastrointestinal cancer

Contacts and locations

Locations

  • Bradfordhill ( Site 0069)

    Santiago, Region M. de Santiago, 8420383, Chile

  • Centre François Baclesse ( Site 0085)

    Caen, Calvados, 14076, France

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

    Montreal, Quebec, H2X 3E4, Canada

  • Centro de Estudios Clínicos SAGA ( Site 0064)

    Santiago, Region M. de Santiago, 7501010, Chile

  • China Medical University Hospital ( Site 0267)

    Taichung, 40447, Taiwan

  • Clínica UC San Carlos de Apoquindo ( Site 0066)

    Santiago, Region M. de Santiago, 7620002, Chile

  • FALP ( Site 0062)

    Santiago, Region M. de Santiago, 7500921, Chile

  • Faculty of Medicine Siriraj Hospital ( Site 0281)

    Bangkok, Bangkok, 10700, Thailand

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

    La Rioja, F5300COE, Argentina

  • Gustave Roussy ( Site 0081)

    Villejuif, Val-de-Marne, 94800, France

  • Hospital Clinic de Barcelona ( Site 0223)

    Barcelona, 08036, Spain

  • Hospital General Universitario Gregorio Marañón ( Site 0225)

    Madrid, 28007, Spain

  • Hospital Universitario Fundacion Jimenez Diaz ( Site 0224)

    Madrid, 28040, Spain

  • Hospital Universitario Marqués de Valdecilla ( Site 0221)

    Santander, Cantabria, 39008, Spain

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

    Geneva, Canton of Geneva, 1211, Switzerland

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

    Badalona, Barcelona, 08916, Spain

  • Institut Regional du Cancer Montpellier ( Site 0084)

    Montpellier, Herault, 34298, France

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

    Rosario, Santa Fe Province, S2000CEJ, Argentina

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

    Mar del Plata, Buenos Aires, B7600FZO, Argentina

  • Mackay Memorial Hospital ( Site 0266)

    Taipei, 104, Taiwan

  • Morristown Medical Center ( Site 0349)

    Morristown, New Jersey, 07960, United States

  • Mt Sinai Comprehensive Cancer Center ( Site 0345)

    Miami Beach, Florida, 33140, United States

  • National Cheng Kung University Hospital ( Site 0263)

    Tainan, 70403, Taiwan

  • National Taiwan University Hospital ( Site 0261)

    Taipei, 10002, Taiwan

  • Nefra Medical Care - CEMIC Saavedra ( Site 0008)

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

  • Pitie Salpetriere University Hospital ( Site 0082)

    Paris, 75013, France

  • Prince of Wales Hospital ( Site 0122)

    Hksar, Hong Kong

  • Princess Margaret Cancer Centre ( Site 0041)

    Toronto, Ontario, M5G 1X6, Canada

  • Queen Mary Hospital ( Site 0121)

    Hksar, Hong Kong

  • Ramathibodi Hospital. ( Site 0282)

    Bangkok, Bangkok, 10400, Thailand

  • Sibley Memorial Hospital ( Site 0372)

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

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

    Billings, Montana, 59102, United States

  • Sunnybrook Research Institute ( Site 0044)

    Toronto, Ontario, M4N 3M5, Canada

  • Taichung Veterans General Hospital ( Site 0265)

    Taichung, 407, Taiwan

  • Taipei Veterans General Hospital ( Site 0262)

    Taipei, 112, Taiwan

  • Universitaetsspital Basel ( Site 0241)

    Basel, Canton of Basel-City, 4031, Switzerland

  • Universitaetsspital Zuerich ( Site 0242)

    Zurich, 8091, Switzerland

  • University Hospitals Cleveland Medical Center ( Site 0369)

    Cleveland, Ohio, 44106, United States

  • University of Virginia Cancer Center ( Site 0365)

    Charlottesville, Virginia, 22903, United States

  • University of Wisconsin Carbone Cancer Center ( Site 0348)

    Madison, Wisconsin, 53792, United States

  • Yale New Haven Hospital ( Site 0375)

    New Haven, Connecticut, 06510, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.