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
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Raludotatug Deruxtecan (R-DXd) |
R-DXd will be administered via IV infusion. |
|
Recruiting Locations
New Haven 4839366, Connecticut 4831725 06510
Study Coordinator
203-314-7948
Washington D.C. 4140963, District of Columbia 4138106 20016
Study Coordinator
202-660-6500
Miami Beach 4164143, Florida 4155751 33140
Study Coordinator
305-535-3310
Billings 5640350, Montana 5667009 59102
Study Coordinator
406-238-6900
Morristown 5101427, New Jersey 5101760 07960
Study Coordinator
973-971-7960
Cleveland 5150529, Ohio 5165418 44106
Study Coordinator
216-354-9912
Charlottesville 4752031, Virginia 6254928 22903
Study Coordinator
434-327-8148
Madison 5261457, Wisconsin 5279468 53792
Study Coordinator
608-265-9966
More Details
- Status
- Recruiting
- Sponsor
- Merck Sharp & Dohme LLC