NCT06864169

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Gastrointestinal Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Raludotatug Deruxtecan (R-DXd)	Administered via intravenous (IV) infusion.

Timeline

• Start date: 2025-04-01
• Primary completion: 2026-08-18
• Completion: 2029-01-04
• First posted: 2025-03-07
• Last updated: 2026-03-04

Locations

41 sites across 10 countries: United States, Argentina, Canada, Chile, France, Hong Kong, Spain, Switzerland, Taiwan, Thailand

Regulatory

• FDA-regulated drug study