RecruitingPhase 1Phase 2NCT06596694

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

A Phase 1/2 Study to Evaluate the Safety and Efficacy of Patritumab Deruxtecan in Gastrointestinal Cancers


Sponsor

Merck Sharp & Dohme LLC

Enrollment

180 participants

Start Date

Nov 3, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria7

  • 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 Criteria6

  • 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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Interventions

BIOLOGICALPatritumab deruxtecan

Administered via intravenous (IV) infusion


Locations(62)

UCLA Hematology Oncology Santa Monica ( Site 1205)

Santa Monica, California, United States

University of Colorado Cancer Center ( Site 1200)

Aurora, Colorado, United States

Sibley Memorial Hospital ( Site 1208)

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

University of Florida ( Site 1202)

Gainesville, Florida, United States

Mount Sinai Medical Center Comprehensive Cancer Center ( Site 1213)

Miami Beach, Florida, United States

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

Marietta, Georgia, United States

University of Chicago Medical Center ( Site 1204)

Chicago, Illinois, United States

Renown Regional Medical Center ( Site 1221)

Reno, Nevada, United States

NYU Langone Hospital - Long Island ( Site 1230)

Mineola, New York, United States

Perlmutter NYU Cancer Center ( Site 1212)

New York, New York, United States

Scott & White Medical Center-Temple ( Site 1224)

Temple, Texas, United States

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

Roanoke, Virginia, United States

University of Wisconsin ( Site 1210)

Madison, Wisconsin, United States

Westmead Hospital ( Site 0100)

Sydney, New South Wales, Australia

Alfred Health ( Site 0102)

Melbourne, Victoria, Australia

Austin Health ( Site 0103)

Melbourne, Victoria, Australia

One Clinical Research ( Site 0104)

Mount Pleasant, Western Australia, Australia

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

Halifax, Nova Scotia, Canada

Sunnybrook Research Institute - Odette Cancer Centre ( Site 0206)

Toronto, Ontario, Canada

McGill University Health Centre ( Site 0202)

Montreal, Quebec, Canada

Fundacion Arturo Lopez Perez ( Site 0301)

Santiago, Region M. de Santiago, Chile

Centro de Oncología de Precisión ( Site 0305)

Santiago, Region M. de Santiago, Chile

Clínica UC San Carlos de Apoquindo ( Site 0302)

Santiago, Region M. de Santiago, Chile

Bradfordhill ( Site 0300)

Santiago, Region M. de Santiago, Chile

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

Hefei, Anhui, China

Fujian Provincial Cancer Hospital ( Site 0408)

Fuzhou, Fujian, China

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

Xiamen, Fujian, China

Southern Medical University Nanfang Hospital ( Site 0413)

Fuzhou, Guangdong, China

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

Guangzhou, Guangdong, China

Affiliated Cancer Hospital of Guangxi Medical University ( Site 0411)

Nanning, Guangxi, China

Henan Cancer Hospital ( Site 0403)

Zhengzhou, Henan, China

Zhongshan Hospital,Fudan University ( Site 0400)

Shanghai, Shanghai Municipality, China

First Hospital of Shanxi Medical University ( Site 0409)

Taiyuan, Shanxi, China

Hopital de la Croix Rousse ( Site 0502)

Lyon, Auvergne-Rhône-Alpes, France

Hopital Beaujon ( Site 0500)

Clichy, Hauts-de-Seine, France

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

Rennes, Ille-et-Vilaine, France

Rambam Health Care Campus ( Site 0603)

Haifa, Israel

Hadassah Medical Center ( Site 0602)

Jerusalem, Israel

Sourasky Medical Center ( Site 0601)

Tel Aviv, Israel

Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 0700)

Milan, Italy

ASST Grande Ospedale Metropolitano Niguarda ( Site 0701)

Milan, Italy

Fondazione Policlinico Universitario Agostino Gemelli ( Site 0702)

Roma, Italy

Harbour Cancer & Wellness ( Site 0800)

Auckland, New Zealand

Seoul National University Hospital ( Site 0900)

Seodaemun-gu, Seoul, South Korea

Severance Hospital, Yonsei University Health System ( Site 0903)

Seoul, South Korea

Asan Medical Center ( Site 0902)

Seoul, South Korea

Samsung Medical Center ( Site 0901)

Seoul, South Korea

Hospital Central de Asturias ( Site 1001)

Oviedo, Principality of Asturias, Spain

Hospital Universitari Vall d'Hebron ( Site 1000)

Barcelona, Spain

Hospital Universitario Gregorio Maranon ( Site 1002)

Madrid, Spain

Hospital Clinico San Carlos... ( Site 1003)

Madrid, Spain

Hopitaux Universitaires de Geneve HUG. ( Site 1102)

Geneva, Switzerland

Universitaetsspital Zuerich ( Site 1105)

Zurich, Switzerland

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

Tainan, Taiwan

National Taiwan University Hospital ( Site 1500)

Taipei, Taiwan

Taipei Veterans General Hospital ( Site 1501)

Taipei, Taiwan

Faculty of Medicine Siriraj Hospital ( Site 1301)

Bangkoknoi, Bangkok, Thailand

Ramathibodi Hospital ( Site 1302)

Ratchathewi, Bangkok, Thailand

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

Yenimahalle, Ankara, Turkey (Türkiye)

Dokuz Eylul Universitesi Hastanesi ( Site 1402)

Balçova, İzmir, Turkey (Türkiye)

Adana City Hospital ( Site 1404)

Adana, Turkey (Türkiye)

Hacettepe Universite Hastaneleri ( Site 1401)

Ankara, Turkey (Türkiye)

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