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NCT06596694PHASE1, PHASE2Recruiting

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

Merck Sharp & Dohme LLC

Start Date

11/3/2024

Completion Date

12/7/2028

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

Age Range: 18 years to No maximum

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

Interventions

BIOLOGICAL

Patritumab deruxtecan

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Conditions

Gastrointestinal Cancer

Locations

UCLA Hematology Oncology Santa Monica ( Site 1205)

Santa Monica, California 90404

United States

University of Colorado Cancer Center ( Site 1200)

Aurora, Colorado 80045

United States

Sibley Memorial Hospital ( Site 1208)

Washington D.C., District of Columbia 20016

United States

University of Florida ( Site 1202)

Gainesville, Florida 32610

United States

Mount Sinai Medical Center Comprehensive Cancer Center ( Site 1213)

Miami Beach, Florida 33140

United States

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

Marietta, Georgia 30060

United States

University of Chicago Medical Center ( Site 1204)

Chicago, Illinois 60637

United States

Renown Regional Medical Center ( Site 1221)

Reno, Nevada 89502

United States

NYU Langone Hospital - Long Island ( Site 1230)

Mineola, New York 11501

United States

Perlmutter NYU Cancer Center ( Site 1212)

New York, New York 10016

United States

Scott & White Medical Center-Temple ( Site 1224)

Temple, Texas 76508

United States

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

Roanoke, Virginia 24014

United States

University of Wisconsin ( Site 1210)

Madison, Wisconsin 53792

United States

Westmead Hospital ( Site 0100)

Sydney, New South Wales 2145

Australia

Alfred Health ( Site 0102)

Melbourne, Victoria 3004

Australia

Austin Health ( Site 0103)

Melbourne, Victoria 3084

Australia

One Clinical Research ( Site 0104)

Mount Pleasant, Western Australia 6009

Australia

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

Halifax, Nova Scotia B3H 2Y9

Canada

Sunnybrook Research Institute - Odette Cancer Centre ( Site 0206)

Toronto, Ontario M4N 3M5

Canada

McGill University Health Centre ( Site 0202)

Montreal, Quebec H4A 3J1

Canada

Fundacion Arturo Lopez Perez ( Site 0301)

Santiago, Region M. de Santiago 7500921

Chile

Centro de Oncología de Precisión ( Site 0305)

Santiago, Region M. de Santiago 7560908

Chile

Clínica UC San Carlos de Apoquindo ( Site 0302)

Santiago, Region M. de Santiago 7620002

Chile

Bradfordhill ( Site 0300)

Santiago, Region M. de Santiago 8420383

Chile

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

Hefei, Anhui 230088

China

Fujian Provincial Cancer Hospital ( Site 0408)

Fuzhou, Fujian 350014

China

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

Xiamen, Fujian 361015

China

Southern Medical University Nanfang Hospital ( Site 0413)

Fuzhou, Guangdong 510515

China

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

Guangzhou, Guangdong 510080

China

Affiliated Cancer Hospital of Guangxi Medical University ( Site 0411)

Nanning, Guangxi 530200

China

Henan Cancer Hospital ( Site 0403)

Zhengzhou, Henan 450008

China

Zhongshan Hospital,Fudan University ( Site 0400)

Shanghai, Shanghai Municipality 200032

China

First Hospital of Shanxi Medical University ( Site 0409)

Taiyuan, Shanxi 030001

China

Hopital de la Croix Rousse ( Site 0502)

Lyon, Auvergne-Rhône-Alpes 69004

France

Hopital Beaujon ( Site 0500)

Clichy, Hauts-de-Seine 92110

France

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

Rennes, Ille-et-Vilaine 35042

France

Rambam Health Care Campus ( Site 0603)

Haifa, 3109601

Israel

Hadassah Medical Center ( Site 0602)

Jerusalem, 9112001

Israel

Sourasky Medical Center ( Site 0601)

Tel Aviv, 6423906

Israel

Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 0700)

Milan, 20133

Italy

ASST Grande Ospedale Metropolitano Niguarda ( Site 0701)

Milan, 20162

Italy

Fondazione Policlinico Universitario Agostino Gemelli ( Site 0702)

Roma, 00168

Italy

Harbour Cancer & Wellness ( Site 0800)

Auckland, 1023

New Zealand

Seoul National University Hospital ( Site 0900)

Seodaemun-gu, Seoul 03080

South Korea

Severance Hospital, Yonsei University Health System ( Site 0903)

Seoul, 03722

South Korea

Asan Medical Center ( Site 0902)

Seoul, 05505

South Korea

Samsung Medical Center ( Site 0901)

Seoul, 06351

South Korea

Hospital Central de Asturias ( Site 1001)

Oviedo, Principality of Asturias 33011

Spain

Hospital Universitari Vall d'Hebron ( Site 1000)

Barcelona, 08035

Spain

Hospital Universitario Gregorio Maranon ( Site 1002)

Madrid, 28007

Spain

Hospital Clinico San Carlos... ( Site 1003)

Madrid, 28040

Spain

Hopitaux Universitaires de Geneve HUG. ( Site 1102)

Geneva, 1211

Switzerland

Universitaetsspital Zuerich ( Site 1105)

Zurich, 8091

Switzerland

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

Tainan, 704

Taiwan

National Taiwan University Hospital ( Site 1500)

Taipei, 10002

Taiwan

Taipei Veterans General Hospital ( Site 1501)

Taipei, 112201

Taiwan

Faculty of Medicine Siriraj Hospital ( Site 1301)

Bangkoknoi, Bangkok 10700

Thailand

Ramathibodi Hospital ( Site 1302)

Ratchathewi, Bangkok 10400

Thailand

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

Yenimahalle, Ankara 06200

Turkey (Türkiye)

Dokuz Eylul Universitesi Hastanesi ( Site 1402)

Balçova, İzmir 35340

Turkey (Türkiye)

Adana City Hospital ( Site 1404)

Adana, 01370

Turkey (Türkiye)

Hacettepe Universite Hastaneleri ( Site 1401)

Ankara, 06230

Turkey (Türkiye)