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

NCT06596694 | Recruiting Phase 1 FDA Drug

• 4 other identifiers: 1022-011MK-1022-0112024-512442-41-00U1111-1305-0677
• Study Type: interventional
• Target: 180
• Locations: 15 countries
• Sites: 62

Brief Summary

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

Outcome Measures

Primary Outcomes (4)

• Number of Participants Experiencing Dose-Limiting Toxicity (DLT) (Dose-Escalation Phase)

  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)

  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

  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)

  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 Outcomes (5)

• Duration of Response (DOR)

  Up to approximately 44 months

• Progression Free Survival (PFS)

  Up to approximately 44 months

• Overall Survival (OS)

  Up to approximately 44 months

• Maximum Plasma Concentration (Cmax) of Patritumab Deruxtecan

  At designated time points (up to ~44 months)

• Trough Concentration (Ctrough) of Patritumab Deruxtecan

  At designated time points (up to ~44 months)

Study Arms (1)

Patritumab deruxtecan

EXPERIMENTAL

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

Interventions

Patritumab deruxtecan BIOLOGICAL

Administered via intravenous (IV) infusion

Also known as: MK-1022, HER3-DXd, U3-1402

Patritumab deruxtecan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead
• Daiichi Sankyo: collaborator

Study Sites (62)

UCLA Hematology Oncology Santa Monica ( Site 1205)

Santa Monica, California, 90404, United States

RECRUITING

University of Colorado Cancer Center ( Site 1200)

Aurora, Colorado, 80045, United States

RECRUITING

Sibley Memorial Hospital ( Site 1208)

Washington D.C., District of Columbia, 20016, United States

RECRUITING

University of Florida ( Site 1202)

Gainesville, Florida, 32610, United States

RECRUITING

Mount Sinai Medical Center Comprehensive Cancer Center ( Site 1213)

Miami Beach, Florida, 33140, United States

RECRUITING

Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 1203)

Marietta, Georgia, 30060, United States

COMPLETED

University of Chicago Medical Center ( Site 1204)

Chicago, Illinois, 60637, United States

RECRUITING

Renown Regional Medical Center ( Site 1221)

Reno, Nevada, 89502, United States

RECRUITING

NYU Langone Hospital - Long Island ( Site 1230)

Mineola, New York, 11501, United States

RECRUITING

Perlmutter NYU Cancer Center ( Site 1212)

New York, New York, 10016, United States

RECRUITING

Scott & White Medical Center-Temple ( Site 1224)

Temple, Texas, 76508, United States

RECRUITING

Oncology and Hematology Associates of Southwest Virginia (BRCC) ( Site 1207)

Roanoke, Virginia, 24014, United States

RECRUITING

University of Wisconsin ( Site 1210)

Madison, Wisconsin, 53792, United States

RECRUITING

Westmead Hospital ( Site 0100)

Sydney, New South Wales, 2145, Australia

RECRUITING

Alfred Health ( Site 0102)

Melbourne, Victoria, 3004, Australia

RECRUITING

Austin Health ( Site 0103)

Melbourne, Victoria, 3084, Australia

RECRUITING

One Clinical Research ( Site 0104)

Mount Pleasant, Western Australia, 6009, Australia

RECRUITING

QEII Health Sciences Centre - Victoria General Site ( Site 0200)

Halifax, Nova Scotia, B3H 2Y9, Canada

RECRUITING

Sunnybrook Research Institute - Odette Cancer Centre ( Site 0206)

Toronto, Ontario, M4N 3M5, Canada

RECRUITING

McGill University Health Centre ( Site 0202)

Montreal, Quebec, H4A 3J1, Canada

RECRUITING

Fundacion Arturo Lopez Perez ( Site 0301)

Santiago, Region M. de Santiago, 7500921, Chile

RECRUITING

Centro de Oncología de Precisión ( Site 0305)

Santiago, Region M. de Santiago, 7560908, Chile

RECRUITING

Clínica UC San Carlos de Apoquindo ( Site 0302)

Santiago, Region M. de Santiago, 7620002, Chile

RECRUITING

Bradfordhill ( Site 0300)

Santiago, Region M. de Santiago, 8420383, Chile

RECRUITING

The First Affiliated Hospital of Anhui Medical University ( Site 0405)

Hefei, Anhui, 230088, China

RECRUITING

Fujian Provincial Cancer Hospital ( Site 0408)

Fuzhou, Fujian, 350014, China

RECRUITING

Zhongshan Hospital Fudan University (Xiamen Branch) ( Site 0412)

Xiamen, Fujian, 361015, China

RECRUITING

Southern Medical University Nanfang Hospital ( Site 0413)

Fuzhou, Guangdong, 510515, China

RECRUITING

The First Affiliated Hospital, Sun Yat-sen University ( Site 0404)

Guangzhou, Guangdong, 510080, China

RECRUITING

Affiliated Cancer Hospital of Guangxi Medical University ( Site 0411)

Nanning, Guangxi, 530201, China

RECRUITING

Henan Cancer Hospital ( Site 0403)

Zhengzhou, Henan, 450008, China

RECRUITING

Zhongshan Hospital,Fudan University ( Site 0400)

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

First Hospital of Shanxi Medical University ( Site 0409)

Taiyuan, Shanxi, 030001, China

RECRUITING

Hopital de la Croix Rousse ( Site 0502)

Lyon, Auvergne-Rhône-Alpes, 69004, France

RECRUITING

Hopital Beaujon ( Site 0500)

Clichy, Hauts-de-Seine, 92110, France

RECRUITING

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

Rennes, Ille-et-Vilaine, 35042, France

RECRUITING

Rambam Health Care Campus ( Site 0603)

Haifa, 3109601, Israel

RECRUITING

Hadassah Medical Center ( Site 0602)

Jerusalem, 9112001, Israel

RECRUITING

Sourasky Medical Center ( Site 0601)

Tel Aviv, 6423906, Israel

RECRUITING

Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 0700)

Milan, 20133, Italy

RECRUITING

ASST Grande Ospedale Metropolitano Niguarda ( Site 0701)

Milan, 20162, Italy

RECRUITING

Fondazione Policlinico Universitario Agostino Gemelli ( Site 0702)

Roma, 00168, Italy

RECRUITING

Harbour Cancer & Wellness ( Site 0800)

Auckland, 1023, New Zealand

RECRUITING

Seoul National University Hospital ( Site 0900)

Seodaemun-gu, Seoul, 03080, South Korea

RECRUITING

Severance Hospital, Yonsei University Health System ( Site 0903)

Seoul, 03722, South Korea

RECRUITING

Asan Medical Center ( Site 0902)

Seoul, 05505, South Korea

RECRUITING

Samsung Medical Center ( Site 0901)

Seoul, 06351, South Korea

RECRUITING

Hospital Central de Asturias ( Site 1001)

Oviedo, Principality of Asturias, 33011, Spain

RECRUITING

Hospital Universitari Vall d'Hebron ( Site 1000)

Barcelona, 08035, Spain

RECRUITING

Hospital Universitario Gregorio Maranon ( Site 1002)

Madrid, 28007, Spain

RECRUITING

Hospital Clinico San Carlos... ( Site 1003)

Madrid, 28040, Spain

RECRUITING

Hopitaux Universitaires de Geneve HUG. ( Site 1102)

Geneva, 1211, Switzerland

RECRUITING

Universitaetsspital Zuerich ( Site 1105)

Zurich, 8091, Switzerland

RECRUITING

National Cheng Kung University Hospital-Clinical Trial Center ( Site 1502)

Tainan, 704, Taiwan

RECRUITING

National Taiwan University Hospital ( Site 1500)

Taipei, 10002, Taiwan

RECRUITING

Taipei Veterans General Hospital ( Site 1501)

Taipei, 112201, Taiwan

RECRUITING

Faculty of Medicine Siriraj Hospital ( Site 1301)

Bangkoknoi, Bangkok, 10700, Thailand

RECRUITING

Ramathibodi Hospital ( Site 1302)

Ratchathewi, Bangkok, 10400, Thailand

RECRUITING

Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi ( Site 1400)

Yenimahalle, Ankara, 06200, Turkey (Türkiye)

RECRUITING

Dokuz Eylul Universitesi Hastanesi ( Site 1402)

Balçova, İzmir, 35340, Turkey (Türkiye)

RECRUITING

Adana City Hospital ( Site 1404)

Adana, 01370, Turkey (Türkiye)

ACTIVE NOT RECRUITING

Hacettepe Universite Hastaneleri ( Site 1401)

Ankara, 06230, Turkey (Türkiye)

ACTIVE NOT RECRUITING

Related Links

• Merck Clinical Trials Information
• Plain Language Summary

MeSH Terms

Conditions

Gastrointestinal Neoplasms

Interventions

patritumab deruxtecan

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Central Study Contacts

Toll Free Number

CONTACT

1-888-577-8839; Trialsites@msd.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2024
• First Posted: September 19, 2024
• Study Start: November 3, 2024
• Primary Completion (Estimated): December 7, 2028
• Study Completion (Estimated): December 7, 2028
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

FR (3); KR (4); AU (4); TH (2); US (13); CN (9); CH (2); CL (4); ES (4); CA (3); IT (3); NZ (1); TU (4); IL (3); TW (3)