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RecruitingLast updated: 20 April 2026

HERTHENA-PanTumor02: This trial is recruiting people with advanced gastrointestinal (GI) cancers to evaluate the safety and effectiveness of an antibody drug-conjugateA Phase 1/2 Study to Evaluate the Safety and Efficacy of Patritumab Deruxtecan in Gastrointestinal Cancers

Trial purpose

Medical clipboardCancer treatment

Tumor type

Multi-Cancer Multi-Cancer

Age

People18+

Trial acronym

HERTHENA-PanTumor02

Clinical summary

Summary

Patritumab Deruxtecan is an investigational antibody-drug conjugate (or ADC). ADCs work by binding to specific proteins on cancer cells and then releasing a drug directly into the cell to damage it.

The goals of this study are to learn:

  • About the safety and how well people tolerate patritumab deruxtecan
  • How many people have the cancer respond (get smaller or go away) to treatment.

Eligible participants will receive patritumab deruxtecan by intravenous (IV) infusion on Day 1 of each 21-day cycle (every 3 weeks).

Conditions

This trial is treating people with advanced gastrointestinal cancers, including colorectal cancer, biliary tract cancer and liver cancer

Eligibility

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

Inclusion

  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
  • Your cancer has not spread to other parts of the body, but it is not possible to perform surgery to remove it (unresectable).
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.

Exclusion

  • You have certain types of non-cancer medical conditions.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov, EU Clinical Trials Register *. View further details about this trial on the registry via the links below:

  • NCT06596694 *
  • 2024-512442-41-00 *
  • 1022-011; MK-1022-011; U1111-1305-0677

Trial sponsor

Merck Sharp & Dohme LLC

Scientific Title

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

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