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Raludotatug Deruxtecan

Phase 2

Gastrointestinal Cancer | Monoclonal antibody | Oncology |Merck & Company, Inc.|Last Updated: Apr 23, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment160
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06864169A Study of Raludotatug Deruxtecan (R-DXd) in People With Gastrointestinal Cancers (MK-5909-005)PHASE2 ACTIVE NOT_RECRUITING 160Apr 1, 2025Jan 4, 2029Apr 23, 202641 United States, Argentina +8
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Study Endpoints
Primary Endpoints
Objective Response Rate (ORR)
Approximately 15 months

ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. The percentage of participants who experience CR or PR as assessed by BICR will be presented.

Secondary Endpoints
Number of Participants who Experience One or More Adverse Events (AEs)
Up to approximately 14 months
Number of Participants who Discontinue Study Treatment due to an AE
Up to approximately 12 months
Duration of Response (DOR)
Up to approximately 49 months
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Raludotatug Deruxtecan (R-DXd)EXPERIMENTALR-DXd will be administered via IV infusion.
Interventions
NameTypeDescription
Raludotatug Deruxtecan (R-DXd)BIOLOGICALAdministered via intravenous (IV) infusion.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites41

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 hola...

Countries:United StatesArgentinaCanadaChileFranceHong KongSpainSwitzerlandTaiwanThailand
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06864169primaryCompletionDate: changed
LOWMay 24, 2026NCT06864169studyFirstPostDate: changed