A Phase 2 interventional study of Raludotatug Deruxtecan (R-DXd) in Gastrointestinal Cancer, sponsored by Merck Sharp & Dohme LLC. Active, not recruiting at 41 sites in 10 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-23.
Sponsored by Merck Sharp & Dohme LLC · Phase 2, Interventional, and Treatment
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).
779 studies on the registry are indexed under Gastrointestinal Neoplasms; 231 are open to participants now.
This study's planned enrollment of 160 is above the median of 60 across 569 interventional studies indexed under Gastrointestinal Neoplasms.
Browse Gastrointestinal Neoplasms studies →Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.
Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
The main inclusion criteria include but are not limited to the following:
Has one of the following cancers:
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
R-DXd will be administered via IV infusion.
Biological: Raludotatug Deruxtecan (R-DXd)
Administered via intravenous (IV) infusion.
Also known as: MK-5909, DS 6000a
Objective Response Rate (ORR)
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.
Time frame: Approximately 15 months
Number of Participants who Experience One or More Adverse Events (AEs)
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be reported.
Time frame: Up to approximately 14 months
Number of Participants who Discontinue Study Treatment due to an AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study treatment due to an AE will be reported.
Time frame: Up to approximately 12 months
Duration of Response (DOR)
For participants who demonstrate a confirmed 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, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR as assessed by BICR will be presented.
Time frame: Up to approximately 49 months
Progression Free Survival (PFS)
PFS is defined as the time from first day of study intervention to the first documented progressive disease (PD) or death due to any cause, whichever occurs first as assessed by BICR. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. The appearance of one or more new lesions is also considered PD. PFS as assessed by BICR will be presented.
Time frame: Up to approximately 49 months
Overall Survival (OS)
OS is defined as the time from the first dose to death due to any cause.
Time frame: Up to approximately 49 months
Plan to share: Yes — https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Merck Sharp & Dohme LLC