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

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

CONDITIONS

Gastrointestinal Cancer

PRODUCT

HER3-DXd

GENDER

ALL

AGE

18 Years

SPONSOR

Merck Sharp & Dohme LLC

COLLABORATOR

Daiichi Sankyo

TRIAL RUNS IN

62 Global Locations

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

  • 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
  • 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
This was last updated on 2025-11-06 19:34:21.773.

The content contained is taken is taken directly from public registry ClinicalTrials.gov and has not been edited.

Information about pipeline compounds or investigational uses of compounds does not imply FDA approval for these compounds or uses, nor does it establish the safety or efficacy of these compounds or uses. There is no guarantee that the pipeline compounds or investigational uses will receive FDA approval. Daiichi Sankyo does not recommend or suggest use of its medicines in a manner inconsistent with FDA-approved labeling.