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
| Arm | Description | Assigned 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. |
|
Recruiting Locations
Santa Monica 5393212, California 5332921 90404
Study Coordinator
310-633-8400
Aurora 5412347, Colorado 5417618 80045
Study Coordinator
720-848-0300
Washington D.C. 4140963, District of Columbia 4138106 20016
Study Coordinator
202-660-6500
Gainesville 4156404, Florida 4155751 32610
Study Coordinator
888-577-8839
Miami Beach 4164143, Florida 4155751 33140
Study Coordinator
888-577-8839
Chicago 4887398, Illinois 4896861 60637
Study Coordinator
888-577-8839
Reno 5511077, Nevada 5509151 89502
Study Coordinator
775-982-5786
Mineola 5127134, New York 5128638 11501
Study Coordinator
516-663-8358
New York 5128581, New York 5128638 10016
Study Coordinator
888-577-8839
Temple 4735966, Texas 4736286 76508
Study Coordinator
254-760-0867
Roanoke 4782167, Virginia 6254928 24014
Study Coordinator
540-982-0237
Madison 5261457, Wisconsin 5279468 53792
Study Coordinator
800-622-8922
More Details
- NCT ID
- NCT06596694
- Status
- Recruiting
- Sponsor
- Merck Sharp & Dohme LLC