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

RecruitingPhase 1, Phase 2

Sponsor: Merck Sharp & Dohme LLC

Conditions: Gastrointestinal Cancer

Interventions: Patritumab deruxtecan

Countries: United States, Australia, Canada, Chile, China, France, Israel, Italy

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (62)

Santa Monica, California, United States
Aurora, Colorado, United States
Washington D.C., District of Columbia, United States
Gainesville, Florida, United States
Miami Beach, Florida, United States
Marietta, Georgia, United States
Chicago, Illinois, United States
Reno, Nevada, United States
Mineola, New York, United States
New York, New York, United States
Temple, Texas, United States
Roanoke, Virginia, United States
Madison, Wisconsin, United States
Sydney, New South Wales, Australia
Melbourne, Victoria, Australia
Melbourne, Victoria, Australia
Mount Pleasant, Western Australia, Australia
Halifax, Nova Scotia, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Santiago, Region M. de Santiago, Chile
Santiago, Region M. de Santiago, Chile
Santiago, Region M. de Santiago, Chile
Santiago, Region M. de Santiago, Chile
Hefei, Anhui, China
Fuzhou, Fujian, China
Xiamen, Fujian, China
Fuzhou, Guangdong, China
Guangzhou, Guangdong, China
Nanning, Guangxi, China
+ 32 more on CT.gov