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

Recruiting now · Phase 1/Phase 2

Conditions studied: Gastrointestinal Cancer

In brief

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

Key facts

Study ID

NCT06596694

Run by

Merck Sharp & Dohme LLC

People needed

180

Starts

2024-11-03

Expected to finish

2028-12-07

Last updated by the study team

2026-08-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• The First Affiliated Hospital, Sun Yat-sen University ( Site 0404) — Guangzhou, Guangdong, China (enrolling)
• Affiliated Cancer Hospital of Guangxi Medical University ( Site 0411) — Nanning, Guangxi, China (enrolling)
• Fujian Provincial Cancer Hospital ( Site 0408) — Fuzhou, Fujian, China (enrolling)
• Southern Medical University Nanfang Hospital ( Site 0413) — Fuzhou, Guangdong, China (enrolling)
• Sibley Memorial Hospital ( Site 1208) — Washington D.C., District of Columbia, United States (enrolling)
• University of Chicago Medical Center ( Site 1204) — Chicago, Illinois, United States (enrolling)
• University of Florida ( Site 1202) — Gainesville, Florida, United States (enrolling)
• University of Colorado Cancer Center ( Site 1200) — Aurora, Colorado, United States (enrolling)
• Mount Sinai Medical Center Comprehensive Cancer Center ( Site 1213) — Miami Beach, Florida, United States (enrolling)
• Zhongshan Hospital Fudan University (Xiamen Branch) ( Site 0412) — Xiamen, Fujian, China (enrolling)
• Oncology and Hematology Associates of Southwest Virginia (BRCC) ( Site 1207) — Roanoke, Virginia, United States (enrolling)
• University of Wisconsin ( Site 1210) — Madison, Wisconsin, United States (enrolling)
• Westmead Hospital ( Site 0100) — Sydney, New South Wales, Australia (enrolling)
• Alfred Health ( Site 0102) — Melbourne, Victoria, Australia (enrolling)
• Austin Health ( Site 0103) — Melbourne, Victoria, Australia (enrolling)
• One Clinical Research ( Site 0104) — Mount Pleasant, Western Australia, Australia (enrolling)
• QEII Health Sciences Centre - Victoria General Site ( Site 0200) — Halifax, Nova Scotia, Canada (enrolling)
• Sunnybrook Research Institute - Odette Cancer Centre ( Site 0206) — Toronto, Ontario, Canada (enrolling)
• McGill University Health Centre ( Site 0202) — Montreal, Quebec, Canada (enrolling)
• Fundacion Arturo Lopez Perez ( Site 0301) — Santiago, Region M. de Santiago, Chile (enrolling)
• Centro de Oncología de Precisión ( Site 0305) — Santiago, Region M. de Santiago, Chile (enrolling)
• Clínica UC San Carlos de Apoquindo ( Site 0302) — Santiago, Region M. de Santiago, Chile (enrolling)
• Bradfordhill ( Site 0300) — Santiago, Region M. de Santiago, Chile (enrolling)
• The First Affiliated Hospital of Anhui Medical University ( Site 0405) — Hefei, Anhui, China (enrolling)
• Henan Cancer Hospital ( Site 0403) — Zhengzhou, Henan, China (enrolling)

Full record on ClinicalTrials.gov

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