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

RecruitingPhase 1/2

A Phase 1/2 Study to Evaluate the Safety and Efficacy of Patritumab Deruxtecan in Gastrointestinal Cancers

Who can join

Ages 18 and older · All sexes

Full 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

About the study

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

What is being tested

Sponsor: Merck Sharp & Dohme LLC · Participants: 180 · Started: Nov 3, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT06596694

Locations in the U.S.

ColoradoUniversity of Colorado Cancer Center ( Site 1200), Aurora
District of ColumbiaSibley Memorial Hospital ( Site 1208), Washington D.C.
FloridaUniversity of Florida ( Site 1202), Gainesville
Mount Sinai Medical Center Comprehensive Cancer Center ( Site 1213), Miami Beach
IllinoisUniversity of Chicago Medical Center ( Site 1204), Chicago
VirginiaOncology and Hematology Associates of Southwest Virginia (BRCC) ( Site 1207), Roanoke
WisconsinUniversity of Wisconsin ( Site 1210), Madison

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.