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Recruiting Phase 1/2 NCT06596694

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

Phase 1/2 – combined early trial
Conditions: Gastrointestinal Cancer

Sponsor: Merck Sharp & Dohme LLC

trial.available_in: БГ
Overview
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
Who can participate
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
Patritumab deruxtecan
BIOLOGICAL
Locations 62
Australia (4)
Alfred Health ( Site 0102)
Melbourne , Victoria
Study Coordinator
Austin Health ( Site 0103)
Melbourne , Victoria
Study Coordinator
One Clinical Research ( Site 0104)
Mount Pleasant , Western Australia
Study Coordinator
Westmead Hospital ( Site 0100)
Sydney , New South Wales
Study Coordinator
Canada (3)
QEII Health Sciences Centre - Victoria General Site ( Site 0200)
Halifax , Nova Scotia
Study Coordinator
McGill University Health Centre ( Site 0202)
Montreal , Quebec
Study Coordinator
Sunnybrook Research Institute - Odette Cancer Centre ( Site 0206)
Toronto , Ontario
Study Coordinator
Chile (4)
Fundacion Arturo Lopez Perez ( Site 0301)
Santiago , Region M. de Santiago
Study Coordinator
Centro de Oncología de Precisión ( Site 0305)
Santiago , Region M. de Santiago
Study Coordinator
Clínica UC San Carlos de Apoquindo ( Site 0302)
Santiago , Region M. de Santiago
Study Coordinator
Bradfordhill ( Site 0300)
Santiago , Region M. de Santiago
Study Coordinator
China (9)
Fujian Provincial Cancer Hospital ( Site 0408)
Fuzhou , Fujian
Study Coordinator
Southern Medical University Nanfang Hospital ( Site 0413)
Fuzhou , Guangdong
Study Coordinator
The First Affiliated Hospital, Sun Yat-sen University ( Site 0404)
Guangzhou , Guangdong
Study Coordinator
The First Affiliated Hospital of Anhui Medical University ( Site 0405)
Hefei , Anhui
Study Coordinator
Affiliated Cancer Hospital of Guangxi Medical University ( Site 0411)
Nanning , Guangxi
Study Coordinator
Zhongshan Hospital,Fudan University ( Site 0400)
Shanghai , Shanghai Municipality
Study Coordinator
First Hospital of Shanxi Medical University ( Site 0409)
Taiyuan , Shanxi
Study Coordinator
Zhongshan Hospital Fudan University (Xiamen Branch) ( Site 0412)
Xiamen , Fujian
Study Coordinator
Henan Cancer Hospital ( Site 0403)
Zhengzhou , Henan
Study Coordinator
France (3)
Hopital Beaujon ( Site 0500)
Clichy , Hauts-de-Seine
Study Coordinator
Hopital de la Croix Rousse ( Site 0502)
Lyon , Auvergne-Rhône-Alpes
Study Coordinator
Centre Eugène Marquis Rennes - Centre de Lutte Contre le Cancer ( Site 0501)
Rennes , Ille-et-Vilaine
Study Coordinator
Israel (3)
Rambam Health Care Campus ( Site 0603)
Haifa
Study Coordinator
Hadassah Medical Center ( Site 0602)
Jerusalem
Study Coordinator
Sourasky Medical Center ( Site 0601)
Tel Aviv
Study Coordinator
Italy (3)
Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 0700)
Milan
Study Coordinator
ASST Grande Ospedale Metropolitano Niguarda ( Site 0701)
Milan
Study Coordinator
Fondazione Policlinico Universitario Agostino Gemelli ( Site 0702)
Roma
Study Coordinator
New Zealand (1)
Harbour Cancer & Wellness ( Site 0800)
Auckland
Study Coordinator
South Korea (4)
Seoul National University Hospital ( Site 0900)
Seodaemun-gu , Seoul
Study Coordinator
Severance Hospital, Yonsei University Health System ( Site 0903)
Seoul
Study Coordinator
Asan Medical Center ( Site 0902)
Seoul
Study Coordinator
Samsung Medical Center ( Site 0901)
Seoul
Study Coordinator
Spain (4)
Hospital Universitari Vall d'Hebron ( Site 1000)
Barcelona
Study Coordinator
Hospital Universitario Gregorio Maranon ( Site 1002)
Madrid
Study Coordinator
Hospital Clinico San Carlos... ( Site 1003)
Madrid
Study Coordinator
Hospital Central de Asturias ( Site 1001)
Oviedo , Principality of Asturias
Study Coordinator
Switzerland (2)
Hopitaux Universitaires de Geneve HUG. ( Site 1102)
Geneva
Study Coordinator
Universitaetsspital Zuerich ( Site 1105)
Zurich
Study Coordinator
Taiwan (3)
National Cheng Kung University Hospital-Clinical Trial Center ( Site 1502)
Tainan
Study Coordinator
National Taiwan University Hospital ( Site 1500)
Taipei
Study Coordinator
Taipei Veterans General Hospital ( Site 1501)
Taipei
Study Coordinator
Thailand (2)
Faculty of Medicine Siriraj Hospital ( Site 1301)
Bangkoknoi , Bangkok
Study Coordinator
Ramathibodi Hospital ( Site 1302)
Ratchathewi , Bangkok
Study Coordinator
Turkey (4)
Adana City Hospital ( Site 1404)
Adana
ACTIVE_NOT_RECRUITING
Hacettepe Universite Hastaneleri ( Site 1401)
Ankara
ACTIVE_NOT_RECRUITING
Dokuz Eylul Universitesi Hastanesi ( Site 1402)
Balçova , İzmir
Study Coordinator
Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi ( Site 1400)
Yenimahalle , Ankara
Study Coordinator
United States (13)
University of Colorado Cancer Center ( Site 1200)
Aurora , Colorado
Study Coordinator
University of Chicago Medical Center ( Site 1204)
Chicago , Illinois
Study Coordinator
University of Florida ( Site 1202)
Gainesville , Florida
Study Coordinator
University of Wisconsin ( Site 1210)
Madison , Wisconsin
Study Coordinator
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 1203)
Marietta , Georgia
COMPLETED
Mount Sinai Medical Center Comprehensive Cancer Center ( Site 1213)
Miami Beach , Florida
Study Coordinator
NYU Langone Hospital - Long Island ( Site 1230)
Mineola , New York
Study Coordinator
Perlmutter NYU Cancer Center ( Site 1212)
New York , New York
Study Coordinator
Renown Regional Medical Center ( Site 1221)
Reno , Nevada
Study Coordinator
Oncology and Hematology Associates of Southwest Virginia (BRCC) ( Site 1207)
Roanoke , Virginia
Study Coordinator
UCLA Hematology Oncology Santa Monica ( Site 1205)
Santa Monica , California
Study Coordinator
Scott & White Medical Center-Temple ( Site 1224)
Temple , Texas
Study Coordinator
Sibley Memorial Hospital ( Site 1208)
Washington D.C. , District of Columbia
Study Coordinator
Technical details
Status
Recruiting
Phase
Phase 1/2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
03.11.2024
Completion date
07.12.2028
Registry ID
NCT06596694
Source
clinicaltrials.gov
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