A Study of Raludotatug Deruxtecan (R-DXd) in People With Gastrointestinal Cancers (MK-5909-005)

Purpose

Researchers are looking for new ways to treat certain types of advanced gastrointestinal (GI) cancers. The study medicine raludotatug deruxtecan (also called MK-5909, R-DXd, or DS-6000a) is a type of medicine called an antibody-drug conjugate (ADC). An ADC attaches to a protein on cancer cells and delivers treatment to destroy those cells. The main goal of this study is to learn if the cancer responds to treatment (gets smaller or goes away).

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 pancreatic ductal adenocarcinoma (PDAC) - Unresectable or metastatic adenocarcinoma of the biliary tract [intra- or extrahepatic holangiocarcinoma (CCA) or gallbladder cancer (GBC)] - Unresectable or metastatic colorectal adenocarcinoma - Unresectable or metastatic gastric adenocarcinoma - Gastroesophageal junction adenocarcinoma (GEJAC) - Esophageal adenocarcinoma (EAC) - Has received prior therapy for the cancer - Has a life expectancy of at least 3 months - If human immunodeficiency virus (HIV) infected, must have well controlled HIV on antiretroviral therapy (ART)

Exclusion Criteria

The main exclusion criteria include but are not limited to the following: - Has a history of (noninfectious) interstitial lung disease (ILD)/pneumonitis that required steroids or has current ILD/pneumonitis, and/or suspected ILD/pneumonitis - Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses - Has uncontrolled or significant cardiovascular disease - Has a known additional malignancy that is progressing or has required active treatment within the past 3 years - Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis - Active autoimmune disease that has required systemic treatment in the past 2 years - Has not adequately recovered from major surgery or has ongoing surgical complications - HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease

Study Design

Phase
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
Raludotatug Deruxtecan (R-DXd)
R-DXd will be administered via IV infusion.
  • Biological: Raludotatug Deruxtecan (R-DXd)
    Administered via intravenous (IV) infusion.
    Other names:
    • MK-5909
    • DS 6000a

Recruiting Locations

Yale New Haven Hospital ( Site 0375)
New Haven 4839366, Connecticut 4831725 06510
Contact:
Study Coordinator
203-314-7948

Sibley Memorial Hospital ( Site 0372)
Washington D.C. 4140963, District of Columbia 4138106 20016
Contact:
Study Coordinator
202-660-6500

Mt Sinai Comprehensive Cancer Center ( Site 0345)
Miami Beach 4164143, Florida 4155751 33140
Contact:
Study Coordinator
305-535-3310

St. Vincent Healthcare Frontier Cancer Center ( Site 0347)
Billings 5640350, Montana 5667009 59102
Contact:
Study Coordinator
406-238-6900

Morristown Medical Center ( Site 0349)
Morristown 5101427, New Jersey 5101760 07960
Contact:
Study Coordinator
973-971-7960

University Hospitals Cleveland Medical Center ( Site 0369)
Cleveland 5150529, Ohio 5165418 44106
Contact:
Study Coordinator
216-354-9912

University of Virginia Cancer Center ( Site 0365)
Charlottesville 4752031, Virginia 6254928 22903
Contact:
Study Coordinator
434-327-8148

University of Wisconsin Carbone Cancer Center ( Site 0348)
Madison 5261457, Wisconsin 5279468 53792
Contact:
Study Coordinator
608-265-9966

More Details

Status
Recruiting
Sponsor
Merck Sharp & Dohme LLC

Study Contact

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