Status:
RECRUITING
Study of Patritumab Deruxtecan in Participants With Gastrointestinal Cancers (MK-1022-011) (HERTHENA-PanTumor02)
Lead Sponsor:
Merck Sharp & Dohme LLC
Collaborating Sponsors:
Daiichi Sankyo
Conditions:
Gastrointestinal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 bod...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 3 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 7 2028
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT06596694
Start Date
November 3 2024
End Date
December 7 2028
Last Update
January 5 2026
Active Locations (62)
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1
UCLA Hematology Oncology Santa Monica ( Site 1205)
Santa Monica, California, United States, 90404
2
University of Colorado Cancer Center ( Site 1200)
Aurora, Colorado, United States, 80045
3
Sibley Memorial Hospital ( Site 1208)
Washington D.C., District of Columbia, United States, 20016
4
University of Florida ( Site 1202)
Gainesville, Florida, United States, 32610