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

Purpose

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

Condition

  • Gastrointestinal Cancer

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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 Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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:
    • MK-1022
    • HER3-DXd
    • U3-1402

Recruiting Locations

UCLA Hematology Oncology Santa Monica ( Site 1205)
Santa Monica 5393212, California 5332921 90404
Contact:
Study Coordinator
310-633-8400

University of Colorado Cancer Center ( Site 1200)
Aurora 5412347, Colorado 5417618 80045
Contact:
Study Coordinator
720-848-0300

Sibley Memorial Hospital ( Site 1208)
Washington D.C. 4140963, District of Columbia 4138106 20016
Contact:
Study Coordinator
202-660-6500

University of Florida ( Site 1202)
Gainesville 4156404, Florida 4155751 32610
Contact:
Study Coordinator
888-577-8839

Mount Sinai Medical Center Comprehensive Cancer Center ( Site 1213)
Miami Beach 4164143, Florida 4155751 33140
Contact:
Study Coordinator
888-577-8839

University of Chicago Medical Center ( Site 1204)
Chicago 4887398, Illinois 4896861 60637
Contact:
Study Coordinator
888-577-8839

Renown Regional Medical Center ( Site 1221)
Reno 5511077, Nevada 5509151 89502
Contact:
Study Coordinator
775-982-5786

NYU Langone Hospital - Long Island ( Site 1230)
Mineola 5127134, New York 5128638 11501
Contact:
Study Coordinator
516-663-8358

Perlmutter NYU Cancer Center ( Site 1212)
New York 5128581, New York 5128638 10016
Contact:
Study Coordinator
888-577-8839

Scott & White Medical Center-Temple ( Site 1224)
Temple 4735966, Texas 4736286 76508
Contact:
Study Coordinator
254-760-0867

Oncology and Hematology Associates of Southwest Virginia (BRCC) ( Site 1207)
Roanoke 4782167, Virginia 6254928 24014
Contact:
Study Coordinator
540-982-0237

University of Wisconsin ( Site 1210)
Madison 5261457, Wisconsin 5279468 53792
Contact:
Study Coordinator
800-622-8922

More Details

NCT ID
NCT06596694
Status
Recruiting
Sponsor
Merck Sharp & Dohme LLC

Study Contact

Toll Free Number
1-888-577-8839
Trialsites@msd.com