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New drug shows promise for Hard-to-Treat GI cancers

NCT ID NCT06596694

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 study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 28, 2026 · Updated 7 times

Summary

This study is testing a drug called patritumab deruxtecan in people with advanced gastrointestinal cancers that have spread. The drug is given through a vein and aims to shrink tumors. The trial will check how safe the drug is and how many people's cancers respond to treatment. About 180 adults with certain types of GI cancers are being recruited.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
patritumab deruxtecan (a targeted antibody-drug conjugate given by IV)
What this could lead to
If it works, this could offer a new treatment option for people with advanced gastrointestinal cancers that have not responded to other therapies.
What could go wrong
This is an early-phase trial (phase 1/2) with a small number of participants, so it is not yet known if the drug will be effective or safe in larger groups. Side effects are possible, and the cancer may still progress.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 180 people

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

Started

Nov 2024

Expected to finish

Dec 2028

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 colorectal cancer. * Advanced and/or unresectable biliary tract cancer (BTC) * Hepatocellular carcinoma (HCC) not amenable to locoregional therapy * Locally advanced unresectable or metastatic gastroesophageal cancer * Has received prior therapy for the cancer. * Has recovered from any side effects due to previous cancer treatment Exclusion Criteria: The main exclusion criteria include but are not limited to the following: * Has a history of (noninfectious) interstitial lung disease (ILD) or pneumonitis that required steroids, or has current ILD or pneumonitis, and/or suspected ILD or pneumonitis that cannot be ruled out by standard diagnostic assessments at Screening * Has clinically severe respiratory compromise (based on the investigator's assessment) resulting from intercurrent pulmonary illnesses * Has evidence of any leptomeningeal disease * Has clinically significant corneal disease * Has uncontrolled, significant cardiovascular disease or cerebrovascular disease * Has evidence of ongoing uncontrolled systemic bacterial, fungal, or viral infection

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Conditions

The condition(s) this trial relates to.

biliary tract cancer colorectal cancer digestive system cancer digestive system neoplasm gastroesophageal cancer hepatocellular carcinoma

As listed by the trial registrant

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

Gastrointestinal cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    51 sites in 15 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • ASST Grande Ospedale Metropolitano Niguarda ( Site 0701)

    RECRUITING

    Milan, 20162, Italy

  • Adana City Hospital ( Site 1404)

    ACTIVE_NOT_RECRUITING

    Adana, 01370, Turkey (Türkiye)

  • Affiliated Cancer Hospital of Guangxi Medical University ( Site 0411)

    RECRUITING

    Nanning, Guangxi, 530200, China

  • Alfred Health ( Site 0102)

    RECRUITING

    Melbourne, Victoria, 3004, Australia

  • Asan Medical Center ( Site 0902)

    RECRUITING

    Seoul, 05505, South Korea

  • Austin Health ( Site 0103)

    ACTIVE_NOT_RECRUITING

    Melbourne, Victoria, 3084, Australia

  • Bradfordhill ( Site 0300)

    RECRUITING

    Santiago, Region M. de Santiago, 8420383, Chile

  • Centre Eugène Marquis Rennes - Centre de Lutte Contre le Cancer ( Site 0501)

    RECRUITING

    Rennes, Ille-et-Vilaine, 35042, France

  • Centro de Oncología de Precisión ( Site 0305)

    RECRUITING

    Santiago, Region M. de Santiago, 7560908, Chile

  • Clínica UC San Carlos de Apoquindo ( Site 0302)

    RECRUITING

    Santiago, Region M. de Santiago, 7620002, Chile

  • Dokuz Eylul Universitesi Hastanesi ( Site 1402)

    RECRUITING

    Balçova, İzmir, 35340, Turkey (Türkiye)

  • Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi ( Site 1400)

    RECRUITING

    Yenimahalle, Ankara, 06200, Turkey (Türkiye)

  • Faculty of Medicine Siriraj Hospital ( Site 1301)

    RECRUITING

    Bangkoknoi, Bangkok, 10700, Thailand

  • First Hospital of Shanxi Medical University ( Site 0409)

    RECRUITING

    Taiyuan, Shanxi, 030001, China

  • Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 0700)

    RECRUITING

    Milan, 20133, Italy

  • Fondazione Policlinico Universitario Agostino Gemelli ( Site 0702)

    RECRUITING

    Roma, 00168, Italy

  • Fujian Provincial Cancer Hospital ( Site 0408)

    RECRUITING

    Fuzhou, Fujian, 350014, China

  • Fundacion Arturo Lopez Perez ( Site 0301)

    RECRUITING

    Santiago, Region M. de Santiago, 7500921, Chile

  • Hacettepe Universite Hastaneleri ( Site 1401)

    ACTIVE_NOT_RECRUITING

    Ankara, 06230, Turkey (Türkiye)

  • Hadassah Medical Center ( Site 0602)

    RECRUITING

    Jerusalem, 9112001, Israel

  • Harbour Cancer & Wellness ( Site 0800)

    RECRUITING

    Auckland, 1023, New Zealand

  • Henan Cancer Hospital ( Site 0403)

    RECRUITING

    Zhengzhou, Henan, 450008, China

  • Hopital Beaujon ( Site 0500)

    RECRUITING

    Clichy, Hauts-de-Seine, 92110, France

  • Hopital de la Croix Rousse ( Site 0502)

    RECRUITING

    Lyon, Auvergne-Rhône-Alpes, 69004, France

  • Hopitaux Universitaires de Geneve HUG. ( Site 1102)

    RECRUITING

    Geneva, 1211, Switzerland

  • Hospital Central de Asturias ( Site 1001)

    RECRUITING

    Oviedo, Principality of Asturias, 33011, Spain

  • Hospital Clinico San Carlos... ( Site 1003)

    RECRUITING

    Madrid, 28040, Spain

  • Hospital Universitari Vall d'Hebron ( Site 1000)

    RECRUITING

    Barcelona, 08035, Spain

  • Hospital Universitario Gregorio Maranon ( Site 1002)

    ACTIVE_NOT_RECRUITING

    Madrid, 28007, Spain

  • McGill University Health Centre ( Site 0202)

    RECRUITING

    Montreal, Quebec, H4A 3J1, Canada

  • Mount Sinai Medical Center Comprehensive Cancer Center ( Site 1213)

    RECRUITING

    Miami Beach, Florida, 33140, United States

  • NYU Langone Hospital - Long Island ( Site 1230)

    COMPLETED

    Mineola, New York, 11501, United States

  • National Cheng Kung University Hospital-Clinical Trial Center ( Site 1502)

    RECRUITING

    Tainan, 704, Taiwan

  • National Taiwan University Hospital ( Site 1500)

    RECRUITING

    Taipei, 10002, Taiwan

  • Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 1203)

    COMPLETED

    Marietta, Georgia, 30060, United States

  • Oncology and Hematology Associates of Southwest Virginia (BRCC) ( Site 1207)

    RECRUITING

    Roanoke, Virginia, 24014, United States

  • One Clinical Research ( Site 0104)

    ACTIVE_NOT_RECRUITING

    Mount Pleasant, Western Australia, 6009, Australia

  • Perlmutter NYU Cancer Center ( Site 1212)

    COMPLETED

    New York, New York, 10016, United States

  • QEII Health Sciences Centre - Victoria General Site ( Site 0200)

    RECRUITING

    Halifax, Nova Scotia, B3H 2Y9, Canada

  • Ramathibodi Hospital ( Site 1302)

    RECRUITING

    Ratchathewi, Bangkok, 10400, Thailand

  • Rambam Health Care Campus ( Site 0603)

    RECRUITING

    Haifa, 3109601, Israel

  • Renown Regional Medical Center ( Site 1221)

    ACTIVE_NOT_RECRUITING

    Reno, Nevada, 89502, United States

  • Samsung Medical Center ( Site 0901)

    RECRUITING

    Seoul, 06351, South Korea

  • Scott & White Medical Center-Temple ( Site 1224)

    COMPLETED

    Temple, Texas, 76508, United States

  • Seoul National University Hospital ( Site 0900)

    RECRUITING

    Seodaemun-gu, Seoul, 03080, South Korea

  • Severance Hospital, Yonsei University Health System ( Site 0903)

    RECRUITING

    Seoul, 03722, South Korea

  • Sibley Memorial Hospital ( Site 1208)

    RECRUITING

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

  • Sourasky Medical Center ( Site 0601)

    RECRUITING

    Tel Aviv, 6423906, Israel

  • Southern Medical University Nanfang Hospital ( Site 0413)

    RECRUITING

    Fuzhou, Guangdong, 510515, China

  • Sunnybrook Research Institute - Odette Cancer Centre ( Site 0206)

    RECRUITING

    Toronto, Ontario, M4N 3M5, Canada

  • Taipei Veterans General Hospital ( Site 1501)

    RECRUITING

    Taipei, 112201, Taiwan

  • The First Affiliated Hospital of Anhui Medical University ( Site 0405)

    RECRUITING

    Hefei, Anhui, 230088, China

  • The First Affiliated Hospital, Sun Yat-sen University ( Site 0404)

    RECRUITING

    Guangzhou, Guangdong, 510080, China

  • UCLA Hematology Oncology Santa Monica ( Site 1205)

    ACTIVE_NOT_RECRUITING

    Santa Monica, California, 90404, United States

  • Universitaetsspital Zuerich ( Site 1105)

    RECRUITING

    Zurich, 8091, Switzerland

  • University of Chicago Medical Center ( Site 1204)

    RECRUITING

    Chicago, Illinois, 60637, United States

  • University of Colorado Cancer Center ( Site 1200)

    RECRUITING

    Aurora, Colorado, 80045, United States

  • University of Florida ( Site 1202)

    RECRUITING

    Gainesville, Florida, 32610, United States

  • University of Wisconsin ( Site 1210)

    RECRUITING

    Madison, Wisconsin, 53792, United States

  • Westmead Hospital ( Site 0100)

    RECRUITING

    Sydney, New South Wales, 2145, Australia

  • Zhongshan Hospital Fudan University (Xiamen Branch) ( Site 0412)

    RECRUITING

    Xiamen, Fujian, 361015, China

  • Zhongshan Hospital,Fudan University ( Site 0400)

    RECRUITING

    Shanghai, Shanghai Municipality, 200032, China

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