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NCT06864169 · ClinicalTrials.gov registry record · Phase 2
A Study of Raludotatug Deruxtecan (R-DXd) in People With Gastrointestinal Cancers (MK-5909-005)
A Phase 2 study of Gastrointestinal Cancer, sponsored by Merck Sharp & Dohme.
- Active
- Registry status
- Phase 2
- Development phase
- 160
- Enrollment target
- 20
- Study locations
NCT06864169: Active Phase 2 study of Gastrointestinal Cancer, sponsored by Merck Sharp & Dohme.
NCT06864169 is a Phase 2 study of Gastrointestinal Cancer that is active but no longer recruiting, run by Merck Sharp & Dohme. The registered enrollment target is 160 participants, below the 226-participant average among 49 other Gastrointestinal Cancer trials with a reported enrollment target (29% lower). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06864169, a Phase 2 study of Gastrointestinal Cancer, is active but no longer recruiting, sponsored by Merck Sharp & Dohme.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 160 participants
- Enrollment target
- 20
- Study locations
Study Summary
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).
Primary Outcome
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.
Conditions Studied
Interventions
- BIOLOGICAL Raludotatug Deruxtecan (R-DXd)
Study Locations (20)
Region M. de Santiago
- FALP ( Site 0062) - Santiago
- Centro de Estudios Clínicos SAGA ( Site 0064) - Santiago
- Clínica UC San Carlos de Apoquindo ( Site 0066) - Santiago
- Bradfordhill ( Site 0069) - Santiago
Ontario
- Sunnybrook Research Institute ( Site 0044) - Toronto
- Princess Margaret Cancer Centre ( Site 0041) - Toronto
Connecticut
- Yale New Haven Hospital ( Site 0375) - New Haven
District of Columbia
- Sibley Memorial Hospital ( Site 0372) - Washington D.C.
Florida
- Mt Sinai Comprehensive Cancer Center ( Site 0345) - Miami Beach
Montana
- St. Vincent Healthcare Frontier Cancer Center ( Site 0347) - Billings
New Jersey
- Morristown Medical Center ( Site 0349) - Morristown
Ohio
- University Hospitals Cleveland Medical Center ( Site 0369) - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 160 participants |
| Start Date | 2025-04-01 |
| Est. Completion | 2029-01-04 |
| Phase | Phase 2 |
What the registry record for NCT06864169 still lists
NCT06864169 is an interventional study that assigns participants to a tested intervention. The registered 160 participants enrollment target is mid-sized for trials with a published cap, below the 226-participant average among 49 other Gastrointestinal Cancer trials with a reported enrollment target (29% lower).
The record links to 1 condition, with Gastrointestinal Cancer appearing as the primary indexed condition, and to 1 intervention - of which Raludotatug Deruxtecan (R-DXd) is the first listed.
NCT06864169 names 20 study sites across 16 states, led by Region M. de Santiago, Ontario, Connecticut.
Frequently Asked Questions
What is clinical trial NCT06864169 about?
NCT06864169 is a clinical study titled "A Study of Raludotatug Deruxtecan (R-DXd) in People With Gastrointestinal Cancers (MK-5909-005)". 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 d...
What is the current status of trial NCT06864169?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 160 participants. The study started on 2025-04-01. Estimated completion is 2029-01-04.
What conditions does trial NCT06864169 study?
This clinical trial studies the following conditions: Gastrointestinal Cancer.
What interventions are being tested in trial NCT06864169?
The interventions under investigation include: Raludotatug Deruxtecan (R-DXd) (BIOLOGICAL).
Who is sponsoring clinical trial NCT06864169?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06864169 being conducted?
This trial has 20 study locations across Connecticut, District of Columbia, Florida, Montana, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06864169's enrollment target sits among peer trials
160 19th of 49 higher than 31 of 49 other Gastrointestinal Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Gastrointestinal Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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