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

Last updated: March 13, 2026
Sponsor: Merck Sharp & Dohme LLC
Overall Status: Active - Recruiting

Phase

1/2

Condition

Stomach Cancer

Gastrointestinal Diseases And Disorders

Colorectal Cancer

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

  • 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

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 thatrequired steroids, or has current ILD or pneumonitis, and/or suspected ILD orpneumonitis that 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: 180
Treatment Group(s): 1
Primary Treatment: Patritumab deruxtecan
Phase: 1/2
Study Start date:
November 03, 2024
Estimated Completion Date:
December 07, 2028

Connect with a study center

  • Westmead Hospital ( Site 0100)

    Sydney, New South Wales 2145
    Australia

    Active - Recruiting

  • Westmead Hospital ( Site 0100)

    Sydney 2147714, New South Wales 2155400 2145
    Australia

    Site Not Available

  • Alfred Health ( Site 0102)

    Melbourne, Victoria 3004
    Australia

    Active - Recruiting

  • Austin Health ( Site 0103)

    Melbourne, Victoria 3084
    Australia

    Active - Recruiting

  • Alfred Health ( Site 0102)

    Melbourne 2158177, Victoria 2145234 3004
    Australia

    Active - Recruiting

  • Austin Health ( Site 0103)

    Melbourne 2158177, Victoria 2145234 3084
    Australia

    Site Not Available

  • One Clinical Research ( Site 0104)

    Mount Pleasant, Western Australia 6009
    Australia

    Active - Recruiting

  • One Clinical Research ( Site 0104)

    Mount Pleasant 10056968, Western Australia 2058645 6009
    Australia

    Site Not Available

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

    Halifax, Nova Scotia B3H 2Y9
    Canada

    Active - Recruiting

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

    Halifax 6324729, Nova Scotia 6091530 B3H 2Y9
    Canada

    Site Not Available

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

    Toronto, Ontario M4N 3M5
    Canada

    Active - Recruiting

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

    Toronto 6167865, Ontario 6093943 M4N 3M5
    Canada

    Site Not Available

  • McGill University Health Centre ( Site 0202)

    Montreal, Quebec H4A 3J1
    Canada

    Active - Recruiting

  • McGill University Health Centre ( Site 0202)

    Montreal 6077243, Quebec 6115047 H4A 3J1
    Canada

    Site Not Available

  • Fundacion Arturo Lopez Perez ( Site 0301)

    Santiago., Region M. De Santiago 7500921
    Chile

    Site Not Available

  • 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

  • Bradfordhill ( Site 0300)

    Santiago 3871336, Region M. de Santiago 8420383
    Chile

    Active - Recruiting

  • Centro de Oncología de Precisión ( Site 0305)

    Santiago 3871336, Region M. de Santiago 7560908
    Chile

    Active - Recruiting

  • Clínica UC San Carlos de Apoquindo ( Site 0302)

    Santiago 3871336, Region M. de Santiago 7620002
    Chile

    Site Not Available

  • Fundacion Arturo Lopez Perez ( Site 0301)

    Santiago 3871336, Region M. de Santiago 7500921
    Chile

    Active - Recruiting

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

    Hefei, Anhui 230088
    China

    Active - Recruiting

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

    Hefei 1808722, Anhui 1818058 230088
    China

    Site Not Available

  • 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

  • Fujian Provincial Cancer Hospital ( Site 0408)

    Fuzhou 1810821, Fujian 1811017 350014
    China

    Site Not Available

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

    Xiamen 1790645, Fujian 1811017 361015
    China

    Site Not Available

  • 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

  • Southern Medical University Nanfang Hospital ( Site 0413)

    Fuzhou 6681232, Guangdong 1809935 510515
    China

    Site Not Available

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

    Guangzhou 1809858, Guangdong 1809935 510080
    China

    Site Not Available

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

    Nanning, Guangxi 530201
    China

    Active - Recruiting

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

    Nanning 1799869, Guangxi 1809867 530201
    China

    Site Not Available

  • Henan Cancer Hospital ( Site 0403)

    Zhengzhou, Henan 450008
    China

    Active - Recruiting

  • Henan Cancer Hospital ( Site 0403)

    Zhengzhou 1784658, Henan 1808520 450008
    China

    Site Not Available

  • Zhongshan Hospital,Fudan University ( Site 0400)

    Shanghai, Shanghai Municipality 200032
    China

    Active - Recruiting

  • Zhongshan Hospital,Fudan University ( Site 0400)

    Shanghai 1796236, Shanghai Municipality 1796231 200032
    China

    Site Not Available

  • First Hospital of Shanxi Medical University ( Site 0409)

    Tai Yuan, Shanxi 030001
    China

    Site Not Available

  • First Hospital of Shanxi Medical University ( Site 0409)

    Taiyuan, Shanxi 030001
    China

    Active - Recruiting

  • First Hospital of Shanxi Medical University ( Site 0409)

    Taiyuan 1793511, Shanxi 1795912 030001
    China

    Site Not Available

  • Hopital de la Croix Rousse ( Site 0502)

    Lyon, Auvergne-Rhône-Alpes 69004
    France

    Active - Recruiting

  • Hopital de la Croix Rousse ( Site 0502)

    Lyon 2996944, Auvergne-Rhône-Alpes 11071625 69004
    France

    Site Not Available

  • Hopital Beaujon ( Site 0500)

    Clichy, Hauts-de-Seine 92110
    France

    Active - Recruiting

  • Hopital Beaujon ( Site 0500)

    Clichy 3024597, Hauts-de-Seine 92110
    France

    Site Not Available

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

    Rennes, Ille-et-Vilaine 35042
    France

    Active - Recruiting

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

    Rennes 2983990, Ille-et-Vilaine 35042
    France

    Site Not Available

  • Rambam Health Care Campus ( Site 0603)

    Haifa, 3109601
    Israel

    Active - Recruiting

  • Rambam Health Care Campus ( Site 0603)

    Haifa 294801, 3109601
    Israel

    Site Not Available

  • Hadassah Medical Center ( Site 0602)

    Jerusalem, 9112001
    Israel

    Active - Recruiting

  • Hadassah Medical Center ( Site 0602)

    Jerusalem 281184, 9112001
    Israel

    Site Not Available

  • Sourasky Medical Center ( Site 0601)

    Tel Aviv, 6423906
    Israel

    Active - Recruiting

  • Sourasky Medical Center ( Site 0601)

    Tel Aviv 293397, 6423906
    Israel

    Site Not Available

  • Hadassah Medical Center ( Site 0602)

    Yerushalayim, 9112001
    Israel

    Site Not Available

  • ASST Grande Ospedale Metropolitano Niguarda ( Site 0701)

    Milan, 20162
    Italy

    Active - Recruiting

  • Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 0700)

    Milan, 20133
    Italy

    Active - Recruiting

  • ASST Grande Ospedale Metropolitano Niguarda ( Site 0701)

    Milan 6951411, 20162
    Italy

    Site Not Available

  • Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 0700)

    Milan 6951411, 20133
    Italy

    Active - Recruiting

  • ASST Grande Ospedale Metropolitano Niguarda ( Site 0701)

    Milano, 20162
    Italy

    Site Not Available

  • 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

  • Fondazione Policlinico Universitario Agostino Gemelli ( Site 0702)

    Roma 8957247, 00168
    Italy

    Site Not Available

  • 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

    Site Not Available

  • Harbour Cancer & Wellness ( Site 0800)

    Auckland, 1023
    New Zealand

    Active - Recruiting

  • Harbour Cancer & Wellness ( Site 0800)

    Auckland 2193733, 1023
    New Zealand

    Site Not Available

  • Seoul National University Hospital ( Site 0900)

    Seodaemun-gu, Seoul 03080
    South Korea

    Active - Recruiting

  • Asan Medical Center ( Site 0902)

    Seoul, 05505
    South Korea

    Active - Recruiting

  • Samsung Medical Center ( Site 0901)

    Seoul, 06351
    South Korea

    Active - Recruiting

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

    Seoul, 03722
    South Korea

    Active - Recruiting

  • Asan Medical Center ( Site 0902)

    Seoul 1835848, 05505
    South Korea

    Site Not Available

  • Samsung Medical Center ( Site 0901)

    Seoul 1835848, 06351
    South Korea

    Active - Recruiting

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

    Seoul 1835848, 03722
    South Korea

    Active - Recruiting

  • Hospital Central de Asturias ( Site 1001)

    Oviedo, Principality of Asturias 33011
    Spain

    Active - Recruiting

  • Hospital Central de Asturias ( Site 1001)

    Oviedo 3114711, Principality of Asturias 3114710 33011
    Spain

    Site Not Available

  • Hospital Universitari Vall d'Hebron ( Site 1000)

    Barcelona, 08035
    Spain

    Active - Recruiting

  • Hospital Universitari Vall d'Hebron ( Site 1000)

    Barcelona 3128760, 08035
    Spain

    Site Not Available

  • 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

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

    Madrid 3117735, 28040
    Spain

    Site Not Available

  • Hospital Universitario Gregorio Maranon ( Site 1002)

    Madrid 3117735, 28007
    Spain

    Active - Recruiting

  • Hopitaux Universitaires de Geneve HUG. ( Site 1102)

    Geneva, 1211
    Switzerland

    Active - Recruiting

  • Hopitaux Universitaires de Geneve HUG. ( Site 1102)

    Geneva 2660646, 1211
    Switzerland

    Site Not Available

  • Hopitaux Universitaires de Geneve HUG. ( Site 1102)

    Geneve, 1211
    Switzerland

    Site Not Available

  • Universitaetsspital Zuerich ( Site 1105)

    Zurich, 8091
    Switzerland

    Active - Recruiting

  • Universitaetsspital Zuerich ( Site 1105)

    Zurich 2657896, 8091
    Switzerland

    Site Not Available

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

    Tainan, 704
    Taiwan

    Active - Recruiting

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

    Tainan 1668355, 704
    Taiwan

    Site Not Available

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

    Tainan City 1668355, 704
    Taiwan

    Site Not Available

  • National Taiwan University Hospital ( Site 1500)

    Taipei, 10002
    Taiwan

    Active - Recruiting

  • Taipei Veterans General Hospital ( Site 1501)

    Taipei, 112201
    Taiwan

    Active - Recruiting

  • National Taiwan University Hospital ( Site 1500)

    Taipei 1668341, 10002
    Taiwan

    Active - Recruiting

  • Taipei Veterans General Hospital ( Site 1501)

    Taipei 1668341, 112201
    Taiwan

    Site Not Available

  • Faculty of Medicine Siriraj Hospital ( Site 1301)

    Bangkoknoi, Bangkok 10700
    Thailand

    Active - Recruiting

  • Ramathibodi Hospital ( Site 1302)

    Ratchathewi, Bangkok 10400
    Thailand

    Active - Recruiting

  • Ramathibodi Hospital ( Site 1302)

    Ratchathewi 7026885, Bangkok 1609348 10400
    Thailand

    Site Not Available

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

    Yenimahalle, Ankara 06200
    Turkey

    Site Not Available

  • Dokuz Eylul Universitesi Hastanesi ( Site 1402)

    Balcova, Izmir 35340
    Turkey

    Site Not Available

  • Adana City Hospital ( Site 1404)

    Adana, 01370
    Turkey

    Site Not Available

  • Hacettepe Universite Hastaneleri ( Site 1401)

    Ankara, 06230
    Turkey

    Site Not Available

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

    Yenimahalle, Ankara 06200
    Turkey (Türkiye)

    Active - Recruiting

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

    Yenimahalle 296954, Ankara 323784 06200
    Turkey (Türkiye)

    Site Not Available

  • Dokuz Eylul Universitesi Hastanesi ( Site 1402)

    Balçova, İzmir 35340
    Turkey (Türkiye)

    Active - Recruiting

  • Dokuz Eylul Universitesi Hastanesi ( Site 1402)

    Balçova 322185, İzmir 311044 35340
    Turkey (Türkiye)

    Site Not Available

  • Adana City Hospital ( Site 1404)

    Adana, 01370
    Turkey (Türkiye)

    Active - Recruiting

  • Adana City Hospital ( Site 1404)

    Adana 325363, 01370
    Turkey (Türkiye)

    Site Not Available

  • Hacettepe Universite Hastaneleri ( Site 1401)

    Ankara, 06230
    Turkey (Türkiye)

    Active - Recruiting

  • Hacettepe Universite Hastaneleri ( Site 1401)

    Ankara 323786, 06230
    Turkey (Türkiye)

    Site Not Available

  • UCLA Hematology Oncology Santa Monica ( Site 1205)

    Santa Monica, California 90404
    United States

    Active - Recruiting

  • UCLA Hematology Oncology Santa Monica ( Site 1205)

    Santa Monica 5393212, California 5332921 90404
    United States

    Site Not Available

  • University of Colorado Cancer Center ( Site 1200)

    Aurora, Colorado 80045
    United States

    Active - Recruiting

  • University of Colorado Cancer Center ( Site 1200)

    Aurora 5412347, Colorado 5417618 80045
    United States

    Site Not Available

  • Sibley Memorial Hospital ( Site 1208)

    Washington, District of Columbia 20016
    United States

    Site Not Available

  • Sibley Memorial Hospital ( Site 1208)

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

    Active - Recruiting

  • Sibley Memorial Hospital ( Site 1208)

    Washington D.C. 4140963, District of Columbia 4138106 20016
    United States

    Site Not Available

  • 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

  • University of Florida ( Site 1202)

    Gainesville 4156404, Florida 4155751 32610
    United States

    Site Not Available

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

    Miami Beach 4164143, Florida 4155751 33140
    United States

    Site Not Available

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

    Marietta, Georgia 30060
    United States

    Completed

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

    Marietta 4207783, Georgia 4197000 30060
    United States

    Site Not Available

  • University of Chicago Medical Center ( Site 1204)

    Chicago, Illinois 60637
    United States

    Active - Recruiting

  • University of Chicago Medical Center ( Site 1204)

    Chicago 4887398, Illinois 4896861 60637
    United States

    Site Not Available

  • Renown Regional Medical Center ( Site 1221)

    Reno, Nevada 89502
    United States

    Active - Recruiting

  • Renown Regional Medical Center ( Site 1221)

    Reno 5511077, Nevada 5509151 89502
    United States

    Site Not Available

  • 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

  • NYU Langone Hospital - Long Island ( Site 1230)

    Mineola 5127134, New York 5128638 11501
    United States

    Site Not Available

  • Perlmutter NYU Cancer Center ( Site 1212)

    New York 5128581, New York 5128638 10016
    United States

    Site Not Available

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

    Temple, Texas 76508
    United States

    Active - Recruiting

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

    Temple 4735966, Texas 4736286 76508
    United States

    Site Not Available

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

    Roanoke, Virginia 24014
    United States

    Active - Recruiting

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

    Roanoke 4782167, Virginia 6254928 24014
    United States

    Site Not Available

  • University of Wisconsin ( Site 1210)

    Madison, Wisconsin 53792
    United States

    Active - Recruiting

  • University of Wisconsin ( Site 1210)

    Madison 5261457, Wisconsin 5279468 53792
    United States

    Site Not Available

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