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Study of Patritumab Deruxtecan for Gastrointestinal Cancers

This study is looking into patritumab deruxtecan, a biological treatment given through an IV (intravenous) infusion, for people with certain advanced gastrointestinal (GI) cancers. These include colorectal cancer, biliary tract cancer, hepatocellular carcinoma (a type of liver cancer), or gastroesophageal cancer that has spread or cannot be removed by surgery. The main goals are to understand how safe patritumab deruxtecan is, how well people tolerate it, and if it can make the cancer shrink or disappear. You may be able to join if you are 18 or older and have one of these specific GI cancers. The study plans to enroll about 180 participants, but its current status is unclear.

Study design
This is an interventional study planning to enroll about 180 participants. The phase of the study is not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for adverse events for up to approximately 44 months after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06596694

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Merck Sharp & Dohme LLC
~180 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:Patritumab deruxtecan

At a glance

Recruiting sites
51 of 62 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants Experiencing Dose-Limiting Toxicity (DLT) (Dose-Escalation Phase)
Measured over Up to 21 days
+3 more outcomes measured

Conditions

Gastrointestinal Cancer

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Colorectal CarcinomaHepatocellular CarcinomaMalignant Digestive System NeoplasmMalignant neoplasm of biliary tractMalignant neoplasm of cardio-esophageal junction of stomach

NCT06596694

Where you'd take part

This study runs at 62 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Affiliated Cancer Hospital of Guangxi Medical University ( Site 0411)

    Nanning, Guangxi, Chinastudy coordinator listed

    Recruiting

  • Alfred Health ( Site 0102)

    Melbourne, Victoria, Australiastudy coordinator listed

    Recruiting

  • Asan Medical Center ( Site 0902)

    Seoul, South Koreastudy coordinator listed

    Recruiting

  • ASST Grande Ospedale Metropolitano Niguarda ( Site 0701)

    Milan, Italystudy coordinator listed

    Recruiting

  • Bradfordhill ( Site 0300)

    Santiago, Region M. de Santiago, Chilestudy coordinator listed

    Recruiting

  • Centre Eugène Marquis Rennes - Centre de Lutte Contre le Cancer ( Site 0501)

    Rennes, Ille-et-Vilaine, Francestudy coordinator listed

    Recruiting

  • Centro de Oncología de Precisión ( Site 0305)

    Santiago, Region M. de Santiago, Chilestudy coordinator listed

    Recruiting

  • Clínica UC San Carlos de Apoquindo ( Site 0302)

    Santiago, Region M. de Santiago, Chilestudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Medical Director · STUDY_DIRECTOR · Merck Sharp & Dohme LLC

Who to contact

Toll Free Number
[email protected]
1-888-577-8839
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Number of Participants Experiencing Dose-Limiting Toxicity (DLT) (Dose-Escalation Phase)Up to 21 days

    DLT will be defined as any drug-related adverse event observed during the DLT evaluation period that results in a change to a given dose or a delay in initiating the next 21-day cycle. The number of participants in the dose-escalation phase who experience a DLT will be presented.

  • Number of Participants with One or More Adverse Events (AEs)Up to approximately 44 months

    An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The number of participants who experience an AE will be presented.

  • Number of Participants who Discontinue Study Intervention Due to an AEUp to approximately 44 months

    An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The number of participants who discontinue study treatment due to an AE will be presented.

  • Objective Response Rate (ORR)Up to approximately 44 months

    ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. The percentage of participants who experience CR or PR as assessed by Blinded Independent Central Review (BICR) will be presented.