Study of Patritumab Deruxtecan in Participants With Gastrointestinal Cancers (MK-1022-011)
Sponsor: Merck Sharp & Dohme LLC
ClinicalTrials ID:NCT06596694
This clinical trial evaluates the safety and efficacy of patritumab deruxtecan in treating advanced GI cancers, including unresectable/metastatic colorectal cancer, advanced biliary tract cancer, and hepatocellular carcinoma. Eligible participants must have received prior therapy and recovered from its side effects. The drug is administered via IV infusion.
Patient Parameters
| Parameter | Options |
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Program 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
Eligibility Criteria
Inclusion Criteria
The main inclusion criteria include but are not limited to the following:
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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
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Has received prior therapy for the cancer.
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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)/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening
- Has clinically severe respiratory compromise (based on the investigator's assessment) resulting from intercurrent pulmonary illnesses
- Has clinically significant corneal disease
- Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Mount Sinai Medical Center Comprehensive Cancer Center ( Site 1213) | 33140 | Miami Beach | Florida |
| Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 1203) | 30060 | Marietta | Georgia |
| Renown Regional Medical Center ( Site 1221) | 89502 | Reno | Nevada |
| Oncology and Hematology Associates of Southwest Virginia (BRCC) ( Site 1207) | 24014 | Roanoke | Virginia |
| University of Wisconsin ( Site 1210) | 53792 | Madison | Wisconsin |
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