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

August 27, 2026 updated by: Merck Sharp & Dohme LLC

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

180

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 2145
        • Recruiting
        • Westmead Hospital ( Site 0100)
        • Contact:
          • Study Coordinator
          • Phone Number: +61403170371
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • Recruiting
        • Alfred Health ( Site 0102)
        • Contact:
          • Study Coordinator
          • Phone Number: +61390763129
      • Melbourne, Victoria, Australia, 3084
        • Active, not recruiting
        • Austin Health ( Site 0103)
    • Western Australia
      • Mount Pleasant, Western Australia, Australia, 6009
        • Active, not recruiting
        • One Clinical Research ( Site 0104)
  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
        • Recruiting
        • QEII Health Sciences Centre - Victoria General Site ( Site 0200)
        • Contact:
          • Study Coordinator
          • Phone Number: 9024736106
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
        • Recruiting
        • Sunnybrook Research Institute - Odette Cancer Centre ( Site 0206)
        • Contact:
          • Study Coordinator
          • Phone Number: 416-480-5000 x64270
    • Quebec
      • Montreal, Quebec, Canada, H4A 3J1
        • Recruiting
        • McGill University Health Centre ( Site 0202)
        • Contact:
          • Study Coordinator
          • Phone Number: 5145772241
  • Chile
    • Region M. de Santiago
      • Santiago, Region M. de Santiago, Chile, 8420383
        • Recruiting
        • Bradfordhill ( Site 0300)
        • Contact:
          • Study Coordinator
          • Phone Number: +569 9874 4662
      • Santiago, Region M. de Santiago, Chile, 7500921
        • Recruiting
        • Fundacion Arturo Lopez Perez ( Site 0301)
        • Contact:
          • Study Coordinator
          • Phone Number: 56224205098
      • Santiago, Region M. de Santiago, Chile, 7560908
        • Recruiting
        • Centro de Oncología de Precisión ( Site 0305)
        • Contact:
          • Study Coordinator
          • Phone Number: +56225189885
      • Santiago, Region M. de Santiago, Chile, 7620002
        • Recruiting
        • Clínica UC San Carlos de Apoquindo ( Site 0302)
        • Contact:
          • Study Coordinator
          • Phone Number: +569 3427 1024
  • China
    • Anhui
      • Hefei, Anhui, China, 230088
        • Recruiting
        • The First Affiliated Hospital of Anhui Medical University ( Site 0405)
        • Contact:
          • Study Coordinator
          • Phone Number: +8613956012561
    • Fujian
      • Fuzhou, Fujian, China, 350014
        • Recruiting
        • Fujian Provincial Cancer Hospital ( Site 0408)
        • Contact:
          • Study Coordinator
          • Phone Number: 0591-62752500
      • Xiamen, Fujian, China, 361015
        • Recruiting
        • Zhongshan Hospital Fudan University (Xiamen Branch) ( Site 0412)
        • Contact:
          • Study Coordinator
          • Phone Number: 05923501990
    • Guangdong
      • Fuzhou, Guangdong, China, 510515
        • Recruiting
        • Southern Medical University Nanfang Hospital ( Site 0413)
        • Contact:
          • Study Coordinator
          • Phone Number: 02061641888
      • Guangzhou, Guangdong, China, 510080
        • Recruiting
        • The First Affiliated Hospital, Sun Yat-sen University ( Site 0404)
        • Contact:
          • Study Coordinator
          • Phone Number: 020-87331952
    • Guangxi
      • Nanning, Guangxi, China, 530200
        • Recruiting
        • Affiliated Cancer Hospital of Guangxi Medical University ( Site 0411)
        • Contact:
          • Study Coordinator
          • Phone Number: 07715333909
    • Henan
      • Zhengzhou, Henan, China, 450008
        • Recruiting
        • Henan Cancer Hospital ( Site 0403)
        • Contact:
          • Study Coordinator
          • Phone Number: 0371-65587625
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200032
        • Recruiting
        • Zhongshan Hospital,Fudan University ( Site 0400)
        • Contact:
          • Study Coordinator
          • Phone Number: +8602164041990
    • Shanxi
      • Taiyuan, Shanxi, China, 030001
        • Recruiting
        • First Hospital of Shanxi Medical University ( Site 0409)
        • Contact:
          • Study Coordinator
          • Phone Number: 0351-4639931
  • France
    • Auvergne-Rhône-Alpes
      • Lyon, Auvergne-Rhône-Alpes, France, 69004
        • Recruiting
        • Hopital de la Croix Rousse ( Site 0502)
        • Contact:
          • Study Coordinator
          • Phone Number: +33426732716
    • Hauts-de-Seine
      • Clichy, Hauts-de-Seine, France, 92110
        • Recruiting
        • Hopital Beaujon ( Site 0500)
        • Contact:
          • Study Coordinator
          • Phone Number: +33140875553
    • Ille-et-Vilaine
      • Rennes, Ille-et-Vilaine, France, 35042
        • Recruiting
        • Centre Eugène Marquis Rennes - Centre de Lutte Contre le Cancer ( Site 0501)
        • Contact:
          • Study Coordinator
          • Phone Number: +33299254417
  • Israel
      • Haifa, Israel, 3109601
        • Recruiting
        • Rambam Health Care Campus ( Site 0603)
        • Contact:
          • Study Coordinator
          • Phone Number: +97247776234
      • Jerusalem, Israel, 9112001
        • Recruiting
        • Hadassah Medical Center ( Site 0602)
        • Contact:
          • Study Coordinator
          • Phone Number: +9722677896
      • Tel Aviv, Israel, 6423906
        • Recruiting
        • Sourasky Medical Center ( Site 0601)
        • Contact:
          • Study Coordinator
          • Phone Number: +97236947832
  • Italy
      • Milan, Italy, 20133
        • Recruiting
        • Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 0700)
        • Contact:
          • Study Coordinator
          • Phone Number: 390223903807
      • Milan, Italy, 20162
        • Recruiting
        • ASST Grande Ospedale Metropolitano Niguarda ( Site 0701)
        • Contact:
          • Study Coordinator
          • Phone Number: +390264443695
      • Roma, Italy, 00168
        • Recruiting
        • Fondazione Policlinico Universitario Agostino Gemelli ( Site 0702)
        • Contact:
          • Study Coordinator
          • Phone Number: +390630155202
  • New Zealand
      • Auckland, New Zealand, 1023
        • Recruiting
        • Harbour Cancer & Wellness ( Site 0800)
        • Contact:
          • Study Coordinator
          • Phone Number: +6492203333
  • South Korea
      • Seoul, South Korea, 03722
        • Recruiting
        • Severance Hospital, Yonsei University Health System ( Site 0903)
        • Contact:
          • Study Coordinator
          • Phone Number: +82222288137
      • Seoul, South Korea, 05505
        • Recruiting
        • Asan Medical Center ( Site 0902)
        • Contact:
          • Study Coordinator
          • Phone Number: +82-2-3010-3910
      • Seoul, South Korea, 06351
        • Recruiting
        • Samsung Medical Center ( Site 0901)
        • Contact:
          • Study Coordinator
          • Phone Number: +82-2-3410-3459
    • Seoul
      • Seodaemun-gu, Seoul, South Korea, 03080
        • Recruiting
        • Seoul National University Hospital ( Site 0900)
        • Contact:
          • Study Coordinator
          • Phone Number: +82220722995
  • Spain
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitari Vall d'Hebron ( Site 1000)
        • Contact:
          • Study Coordinator
          • Phone Number: +34 93 274 60 60
      • Madrid, Spain, 28040
        • Recruiting
        • Hospital Clinico San Carlos... ( Site 1003)
        • Contact:
          • Study Coordinator
          • Phone Number: 34913303000 x484833
      • Madrid, Spain, 28007
        • Active, not recruiting
        • Hospital Universitario Gregorio Maranon ( Site 1002)
    • Principality of Asturias
      • Oviedo, Principality of Asturias, Spain, 33011
        • Recruiting
        • Hospital Central de Asturias ( Site 1001)
        • Contact:
          • Study Coordinator
          • Phone Number: 34 985108000 x36582
  • Switzerland
      • Geneva, Switzerland, 1211
        • Recruiting
        • Hopitaux Universitaires de Geneve HUG. ( Site 1102)
        • Contact:
          • Study Coordinator
          • Phone Number: +41 22 372 29 01
      • Zurich, Switzerland, 8091
        • Recruiting
        • Universitaetsspital Zuerich ( Site 1105)
        • Contact:
          • Study Coordinator
          • Phone Number: 044 255 11 11.
  • Taiwan
      • Tainan, Taiwan, 704
        • Recruiting
        • National Cheng Kung University Hospital-Clinical Trial Center ( Site 1502)
        • Contact:
          • Study Coordinator
          • Phone Number: +88662353535x4559
      • Taipei, Taiwan, 10002
        • Recruiting
        • National Taiwan University Hospital ( Site 1500)
        • Contact:
          • Study Coordinator
          • Phone Number: 886921893087
      • Taipei, Taiwan, 112201
        • Recruiting
        • Taipei Veterans General Hospital ( Site 1501)
        • Contact:
          • Study Coordinator
          • Phone Number: 886981041675
  • Thailand
    • Bangkok
      • Bangkoknoi, Bangkok, Thailand, 10700
        • Recruiting
        • Faculty of Medicine Siriraj Hospital ( Site 1301)
        • Contact:
          • Study Coordinator
          • Phone Number: +6624194488
      • Ratchathewi, Bangkok, Thailand, 10400
        • Recruiting
        • Ramathibodi Hospital ( Site 1302)
        • Contact:
          • Study Coordinator
          • Phone Number: +6622011671
  • Turkey (Türkiye)
      • Adana, Turkey (Türkiye), 01370
        • Active, not recruiting
        • Adana City Hospital ( Site 1404)
      • Ankara, Turkey (Türkiye), 06230
        • Active, not recruiting
        • Hacettepe Universite Hastaneleri ( Site 1401)
    • Ankara
      • Yenimahalle, Ankara, Turkey (Türkiye), 06200
        • Recruiting
        • Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi ( Site 1400)
        • Contact:
          • Study Coordinator
          • Phone Number: +90 312 336 09 09
    • İzmir
      • Balçova, İzmir, Turkey (Türkiye), 35340
        • Recruiting
        • Dokuz Eylul Universitesi Hastanesi ( Site 1402)
        • Contact:
          • Study Coordinator
          • Phone Number: +90 (232) 412 22 22
  • United States
    • California
      • Santa Monica, California, United States, 90404
        • Active, not recruiting
        • UCLA Hematology Oncology Santa Monica ( Site 1205)
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University of Colorado Cancer Center ( Site 1200)
        • Contact:
          • Study Coordinator
          • Phone Number: 720-848-0300
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20016
        • Recruiting
        • Sibley Memorial Hospital ( Site 1208)
        • Contact:
          • Study Coordinator
          • Phone Number: 202-660-6500
    • Florida
      • Gainesville, Florida, United States, 32610
        • Recruiting
        • University of Florida ( Site 1202)
        • Contact:
          • Study Coordinator
          • Phone Number: 352-273-5045
      • Miami Beach, Florida, United States, 33140
        • Recruiting
        • Mount Sinai Medical Center Comprehensive Cancer Center ( Site 1213)
        • Contact:
          • Study Coordinator
          • Phone Number: 305-674-2625
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Completed
        • Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 1203)
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • University of Chicago Medical Center ( Site 1204)
        • Contact:
          • Study Coordinator
          • Phone Number: 773-702-1220
    • Nevada
      • Reno, Nevada, United States, 89502
        • Active, not recruiting
        • Renown Regional Medical Center ( Site 1221)
    • New York
      • Mineola, New York, United States, 11501
        • Completed
        • NYU Langone Hospital - Long Island ( Site 1230)
      • New York, New York, United States, 10016
        • Completed
        • Perlmutter NYU Cancer Center ( Site 1212)
    • Texas
      • Temple, Texas, United States, 76508
        • Completed
        • Scott & White Medical Center-Temple ( Site 1224)
    • Virginia
      • Roanoke, Virginia, United States, 24014
        • Recruiting
        • Oncology and Hematology Associates of Southwest Virginia (BRCC) ( Site 1207)
        • Contact:
          • Study Coordinator
          • Phone Number: 540-982-0237
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Recruiting
        • University of Wisconsin ( Site 1210)
        • Contact:
          • Study Coordinator
          • Phone Number: 800-622-8922

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patritumab deruxtecan
Participants receive patritumab deruxtecan intravenous (IV) infusion on Day 1 of each 21-day cycle (every 3 weeks) until disease progression, intolerable toxicity, or investigator decision.
Biological: Patritumab deruxtecan
Administered via intravenous (IV) infusion
Other Names:
  • U3-1402
  • HER3-DXd
  • MK-1022

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Experiencing Dose-Limiting Toxicity (DLT) (Dose-Escalation Phase)
Time Frame: 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.
Up to 21 days
Number of Participants with One or More Adverse Events (AEs)
Time Frame: 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.
Up to approximately 44 months
Number of Participants who Discontinue Study Intervention Due to an AE
Time Frame: 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 discontinue study treatment due to an AE will be presented.
Up to approximately 44 months
Objective Response Rate (ORR)
Time Frame: 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.
Up to approximately 44 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of Response (DOR)
Time Frame: Up to approximately 44 months
For participants who demonstrate a confirmed 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 RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR as assessed by BICR will be presented.
Up to approximately 44 months
Progression Free Survival (PFS)
Time Frame: Up to approximately 44 months
PFS is defined as the time from first day of study intervention to the first documented progressive disease (PD) or death due to any cause, whichever occurs first as assessed by BICR. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. The appearance of one or more new lesions is also considered PD. PFS as assessed by BICR will be presented.
Up to approximately 44 months
Overall Survival (OS)
Time Frame: Up to approximately 44 months
OS is the length of time from when the participant starts treatment until death from any cause.
Up to approximately 44 months
Maximum Plasma Concentration (Cmax) of Patritumab Deruxtecan
Time Frame: At designated time points (up to ~44 months)
Blood samples collected at protocol specific time points will be used to determine the Cmax of patritumab deruxtecan.
At designated time points (up to ~44 months)
Trough Concentration (Ctrough) of Patritumab Deruxtecan
Time Frame: At designated time points (up to ~44 months)
Blood samples collected at protocol specific time points will be used to determine the Ctrough of patritumab deruxtecan.
At designated time points (up to ~44 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Collaborators

Daiichi Sankyo

Investigators

  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 3, 2024

Primary Completion (Estimated)

December 7, 2028

Study Completion (Estimated)

December 7, 2028

Study Registration Dates

First Submitted

September 11, 2024

First Submitted That Met QC Criteria

September 11, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Actual)

August 28, 2026

Last Update Submitted That Met QC Criteria

August 27, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1022-011
  • MK-1022-011 (Other Identifier: MSD)
  • U1111-1305-0677 (Registry Identifier: UTN)
  • 2024-512442-41-00 (Registry Identifier: EU CT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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