Study of Patritumab Deruxtecan in Participants With Gastrointestinal Cancers (MK-1022-011) (HERTHENA-PanTumor02)

Last updated: June 20, 2025
Sponsor: Merck Sharp & Dohme LLC
Overall Status: Active - Recruiting

Phase

1/2

Condition

Abdominal Cancer

Colon Cancer

Gastrointestinal Diseases And Disorders

Treatment

Patritumab deruxtecan

Clinical Study ID

NCT06596694
1022-011
2024-512442-41-00
MK-1022-011
U1111-1305-0677
2024-512442-41
  • Ages > 18
  • All Genders

Study Summary

Researchers want to learn if patritumab deruxtecan (MK-1022) can treat certain gastrointestinal (GI) cancers. The GI cancers being studied are advanced (the cancer has spread to other parts of the body). The goals of this study are to learn:

  • About the safety and how well people tolerate of patritumab deruxtecan

  • How many people have the cancer respond (get smaller or go away) to treatment

Eligibility Criteria

Inclusion

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

  • Has received prior therapy for the cancer.

  • Has recovered from any side effects due to previous cancer treatment

Exclusion

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

  • Has a history of (noninfectious) interstitial lung disease (ILD)/pneumonitis thatrequired steroids, or has current ILD/pneumonitis, and/or suspected ILD/pneumonitisthat cannot be ruled out by standard diagnostic assessments at Screening

  • Has clinically severe respiratory compromise (based on the investigator'sassessment) 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

Study Design

Total Participants: 130
Treatment Group(s): 1
Primary Treatment: Patritumab deruxtecan
Phase: 1/2
Study Start date:
November 03, 2024
Estimated Completion Date:
July 24, 2028

Connect with a study center

  • Westmead Hospital ( Site 0100)

    Sydney, New South Wales 2145
    Australia

    Active - Recruiting

  • Alfred Health ( Site 0102)

    Melbourne, Victoria 3004
    Australia

    Active - Recruiting

  • Austin Health ( Site 0103)

    Melbourne, Victoria 3084
    Australia

    Active - Recruiting

  • One Clinical Research ( Site 0104)

    Mount Pleasant, Western Australia 6009
    Australia

    Active - Recruiting

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

    Halifax, Nova Scotia B3H 2Y9
    Canada

    Active - Recruiting

  • Bradfordhill ( Site 0300)

    Santiago, Region M. De Santiago 8420383
    Chile

    Active - Recruiting

  • Centro de Oncología de Precisión ( Site 0305)

    Santiago, Region M. De Santiago 7560908
    Chile

    Active - Recruiting

  • Clínica UC San Carlos de Apoquindo ( Site 0302)

    Santiago, Region M. De Santiago 7620002
    Chile

    Active - Recruiting

  • Fundacion Arturo Lopez Perez ( Site 0301)

    Santiago., Region M. De Santiago 7500921
    Chile

    Active - Recruiting

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

    Hefei, Anhui 230022
    China

    Active - Recruiting

  • Fujian Provincial Cancer Hospital ( Site 0408)

    Fuzhou, Fujian 350014
    China

    Active - Recruiting

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

    Xiamen, Fujian 361015
    China

    Active - Recruiting

  • Southern Medical University Nanfang Hospital ( Site 0413)

    Fuzhou, Guangdong 510515
    China

    Active - Recruiting

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

    Guangzhou, Guangdong 510080
    China

    Active - Recruiting

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

    Nanning, Guangxi 530201
    China

    Active - Recruiting

  • Henan Cancer Hospital ( Site 0403)

    Zhengzhou, Henan 450008
    China

    Active - Recruiting

  • Zhongshan Hospital,Fudan University ( Site 0400)

    Shanghai, Shanghai 200032
    China

    Active - Recruiting

  • First Hospital of Shanxi Medical University ( Site 0409)

    Tai Yuan, Shanxi 030001
    China

    Active - Recruiting

  • Hopital Beaujon ( Site 0500)

    Clichy, Hauts-de-Seine 92110
    France

    Active - Recruiting

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

    Rennes, Ille-et-Vilaine 35042
    France

    Active - Recruiting

  • Hopital de la Croix Rousse ( Site 0502)

    Lyon, Rhone-Alpes 69004
    France

    Active - Recruiting

  • Rambam Health Care Campus ( Site 0603)

    Haifa, 3109601
    Israel

    Active - Recruiting

  • Sourasky Medical Center ( Site 0601)

    Tel Aviv, 6423906
    Israel

    Active - Recruiting

  • Hadassah Medical Center ( Site 0602)

    Yerushalayim, 9112001
    Israel

    Active - Recruiting

  • ASST Grande Ospedale Metropolitano Niguarda ( Site 0701)

    Milano, 20162
    Italy

    Active - Recruiting

  • Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 0700)

    Milano, 20133
    Italy

    Active - Recruiting

  • Fondazione Policlinico Universitario Agostino Gemelli ( Site 0702)

    Roma, 00168
    Italy

    Active - Recruiting

  • Seoul National University Hospital ( Site 0900)

    Seodaemun-gu, Seoul 03080
    Korea, Republic of

    Active - Recruiting

  • Asan Medical Center ( Site 0902)

    Seoul, 05505
    Korea, Republic of

    Active - Recruiting

  • Samsung Medical Center ( Site 0901)

    Seoul, 06351
    Korea, Republic of

    Active - Recruiting

  • Seoul National Hospital ( Site 0900)

    Seoul, 03080
    Korea, Republic of

    Active - Recruiting

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

    Seoul, 03722
    Korea, Republic of

    Active - Recruiting

  • Harbour Cancer & Wellness ( Site 0800)

    Auckland, 1023
    New Zealand

    Active - Recruiting

  • Hospital Central de Asturias ( Site 1001)

    Oviedo, Asturias 33011
    Spain

    Active - Recruiting

  • Hospital Universitari Vall d'Hebron ( Site 1000)

    Barcelona, 08035
    Spain

    Active - Recruiting

  • Hospital Clinico San Carlos ( Site 1003)

    Madrid, 28040
    Spain

    Active - Recruiting

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

    Madrid, 28040
    Spain

    Active - Recruiting

  • Hospital Universitario Gregorio Maranon ( Site 1002)

    Madrid, 28007
    Spain

    Active - Recruiting

  • Hopitaux Universitaires de Geneve HUG. ( Site 1102)

    Geneve, 1211
    Switzerland

    Active - Recruiting

  • Universitaetsspital Zuerich ( Site 1105)

    Zurich, 8091
    Switzerland

    Active - Recruiting

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

    Tainan, 704
    Taiwan

    Active - Recruiting

  • National Taiwan University Hospital ( Site 1500)

    Taipei, 10002
    Taiwan

    Active - Recruiting

  • Taipei Veterans General Hospital ( Site 1501)

    Taipei, 112201
    Taiwan

    Active - Recruiting

  • Faculty of Medicine Siriraj Hospital ( Site 1301)

    Bangkoknoi, Krung Thep Maha Nakhon 10700
    Thailand

    Active - Recruiting

  • Ramathibodi Hospital ( Site 1302)

    Ratchathewi, Krung Thep Maha Nakhon 10400
    Thailand

    Active - Recruiting

  • Hacettepe Universite Hastaneleri ( Site 1401)

    Ankara, 06230
    Turkey

    Active - Recruiting

  • UCLA Hematology Oncology Santa Monica ( Site 1205)

    Santa Monica, California 90404
    United States

    Active - Recruiting

  • Sibley Memorial Hospital ( Site 1208)

    Washington, District of Columbia 20016
    United States

    Active - Recruiting

  • University of Florida ( Site 1202)

    Gainesville, Florida 32610
    United States

    Active - Recruiting

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

    Miami Beach, Florida 33140
    United States

    Active - Recruiting

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

    Marietta, Georgia 30060
    United States

    Active - Recruiting

  • University of Chicago Medical Center ( Site 1204)

    Chicago, Illinois 60637
    United States

    Active - Recruiting

  • Renown Regional Medical Center ( Site 1221)

    Reno, Nevada 89502
    United States

    Active - Recruiting

  • NYU Langone Hospital - Long Island ( Site 1230)

    Mineola, New York 11501
    United States

    Active - Recruiting

  • Perlmutter NYU Cancer Center ( Site 1212)

    New York, New York 10016
    United States

    Active - Recruiting

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

    Roanoke, Virginia 24014
    United States

    Active - Recruiting

  • University of Wisconsin ( Site 1210)

    Madison, Wisconsin 53792
    United States

    Active - Recruiting

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