A Study of Raludotatug Deruxtecan (R-DXd) in People With Gastrointestinal Cancers (MK-5909-005)
A Phase 2 Nonrandomized, Open-label, Multisite Study to Evaluate the Safety and Efficacy of Raludotatug Deruxtecan in Participants With Gastrointestinal Cancers
Sponsor: Merck Sharp & Dohme LLC + Daiichi Sankyo
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Objective Response Rate (ORR)
Time frame: Approximately 15 months
Secondary Endpoints
Number of Participants who Experience One or More Adverse Events (AEs)
Number of Participants who Discontinue Study Treatment due to an AE
Duration of Response (DOR)
Eligibility Criteria
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 I…
Read full criteria on CT.gov →✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
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