Recruiting
Phase 1
Phase 2

Patritumab Deruxtecan

Sponsor:

Merck Sharp & Dohme LLC

Code:

NCT06596694

Conditions

Gastrointestinal Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Patritumab deruxtecan

Study Details

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

Study ID

NCT06596694

Start date

Nov 3, 2024

Status verified date

Aug, 2026

Completion date

Dec 7, 2028

Anticipated

Primary completion date

Dec 7, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

180 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

Patritumab deruxtecan

Administered via intravenous (IV) infusion

Primary outcome measure

  • Number of Participants Experiencing Dose-Limiting Toxicity (DLT) (Dose-Escalation Phase) [ Time Frame: Up to 21 days ]
  • Number of Participants with One or More Adverse Events (AEs) [ Time Frame: Up to approximately 44 months ]
  • Number of Participants who Discontinue Study Intervention Due to an AE [ Time Frame: Up to approximately 44 months ]
  • Objective Response Rate (ORR) [ Time Frame: Up to approximately 44 months ]

Central Contacts and Locations

Central contacts

Toll Free Number

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

Locations

University of Colorado Cancer Center ( Site 1200)

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Study Coordinator

720-848-0300

Sibley Memorial Hospital ( Site 1208)

Recruiting

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

Contacts

Study Coordinator

202-660-6500

University of Florida ( Site 1202)

Recruiting

Gainesville, Florida, United States, 32610

Contacts

Study Coordinator

352-273-5045

Mount Sinai Medical Center Comprehensive Cancer Center ( Site 1213)

Recruiting

Miami Beach, Florida, United States, 33140

Contacts

Study Coordinator

305-674-2625

University of Chicago Medical Center ( Site 1204)

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Study Coordinator

773-702-1220

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

Recruiting

Roanoke, Virginia, United States, 24014

Contacts

Study Coordinator

540-982-0237

University of Wisconsin ( Site 1210)

Recruiting

Madison, Wisconsin, United States, 53792

Contacts

Study Coordinator

800-622-8922

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

Recruiting

Halifax, Nova Scotia, Canada, B3H 2Y9

Contacts

Study Coordinator

9024736106

Sunnybrook Research Institute - Odette Cancer Centre ( Site 0206)

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

Study Coordinator

416-480-5000 x64270

McGill University Health Centre ( Site 0202)

Recruiting

Montreal, Quebec, Canada, H4A 3J1

Contacts

Study Coordinator

5145772241

More Information

Sponsor

Merck Sharp & Dohme LLC

Last update posted

Aug 28, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Merck Sharp & Dohme LLC on 2026-08-28.