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Treatment of advanced gastrointestinal cancers with patritumab deruxtecan

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

Phase1; Phase2 Interventional Merck Sharp & Dohme LLC · NCT06596694

This study is testing a new treatment called patritumab deruxtecan to see if it helps people with advanced gastrointestinal cancers feel better and respond well after other treatments.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment180 (estimated)
Ages18 Years and up
SexAll
SponsorMerck Sharp & Dohme LLC Industry-sponsored
Drugs / interventionspatritumab
Locations62 sites (Santa Monica, California and 61 other locations)
Trial IDNCT06596694 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the efficacy and safety of patritumab deruxtecan (MK-1022) in patients with advanced gastrointestinal cancers, including unresectable colorectal cancer, biliary tract cancer, and hepatocellular carcinoma. The study aims to determine how well patients tolerate the treatment and the rate at which their cancer responds to it. Participants must have previously received therapy for their cancer and have recovered from any side effects. The trial is conducted in multiple locations across the United States.

Who should consider this trial

Good fit: Ideal candidates include individuals with unresectable or metastatic colorectal cancer, advanced biliary tract cancer, or hepatocellular carcinoma who have previously undergone cancer treatment.

Not a fit: Patients with a history of severe interstitial lung disease, significant respiratory compromise, or certain ocular conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced gastrointestinal cancers.

How similar studies have performed: Other studies have shown promise with similar treatments targeting gastrointestinal cancers, indicating potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Santa Monica, California and 61 other locations

+12 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Gastrointestinal Cancer
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.