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Study of Patritumab Deruxtecan in Participants With Gastrointestinal Cancers (MK-1022-011) (HERTHENA-PanTumor02)
RECRUITINGPhase 1/2Sponsored by Merck Sharp & Dohme LLC
Actively Recruiting
PhasePhase 1/2
SponsorMerck Sharp & Dohme LLC
Started2024-11-03
Est. completion2028-12-07
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations13 sites
View on ClinicalTrials.gov →
NCT06596694
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
Age: 18 Years+Healthy volunteers accepted
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
Conditions2
CancerGastrointestinal Cancer
Locations13 sites
UCLA Hematology Oncology Santa Monica ( Site 1205)
Santa Monica, California, 90404
Study Coordinator310-633-8400
University of Colorado Cancer Center ( Site 1200)
Aurora, Colorado, 80045
Study Coordinator720-848-0300
Sibley Memorial Hospital ( Site 1208)
Washington D.C., District of Columbia, 20016
Study Coordinator202-660-6500
University of Florida ( Site 1202)
Gainesville, Florida, 32610
Study Coordinator888-577-8839
Mount Sinai Medical Center Comprehensive Cancer Center ( Site 1213)
Miami Beach, Florida, 33140
Study Coordinator888-577-8839
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Actively Recruiting
PhasePhase 1/2
SponsorMerck Sharp & Dohme LLC
Started2024-11-03
Est. completion2028-12-07
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations13 sites
View on ClinicalTrials.gov →
NCT06596694