A Study of Raludotatug Deruxtecan (R-DXd) in People With Gastrointestinal Cancers (MK-5909-005)
Sponsor: Merck Sharp & Dohme LLC
ClinicalTrials ID:NCT06864169
This study evaluates the efficacy of Raludotatug Deruxtecan (R-DXd), an antibody-drug conjugate, in treating advanced GI cancers. Eligible participants have specific unresectable or metastatic GI cancers, have undergone prior therapy, and have a life expectancy of at least 3 months. R-DXd is administered via IV infusion. Participants with controlled HIV on ART are also eligible.
Patient Parameters
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Program Overview
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).
Eligibility Criteria
Inclusion Criteria
The main inclusion criteria include but are not limited to the following:
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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)
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Has received prior therapy for the cancer
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Has a life expectancy of at least 3 months
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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
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Mt Sinai Comprehensive Cancer Center ( Site 0345) | 33140 | Miami Beach | Florida |
| St. Vincent Healthcare Frontier Cancer Center ( Site 0347) | 59102 | Billings | Montana |
| University of Wisconsin Carbone Cancer Center ( Site 0348) | 53792 | Madison | Wisconsin |
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