NCT07405151

A Clinical Trial of Ifinatamab Deruxtecan in People With Advanced Esophageal Cancer (MK-3475-06F)

A Phase 2 Open-Label, Umbrella Platform Design Study of Investigational Agent(s) in Participants With 2L/3L Unresectable Locally Advanced or Metastatic Esophageal Cancer: KEYMAKER-U06 Substudy 06F

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this trial is to assess if ifinatamab deruxtecan (I-DXd) can treat esophageal squamous cell carcinoma (ESCC). I-DXd is an antibody-drug conjugate (ADC). An ADC attaches to a protein on cancer cells and delivers treatment to destroy those cells. The goal of this trial is to learn how many participants who receive I-DXd have the cancer respond, which means the cancer gets smaller or goes away.

Detailed description

The master screening protocol is MK-3475-U06 (KEYMAKER-U06)

Conditions

• Oesophageal Squamous Cell Carcinoma

Interventions

Type	Name	Description
BIOLOGICAL	I-DXd	IV Infusion
DRUG	Rescue Medication	Includes 5-HT3 receptor antagonist, NK-1 receptor antagonist, and corticosteroid, administered per approved product label

Timeline

• Start date: 2026-03-27
• Primary completion: 2027-06-12
• Completion: 2028-06-12
• First posted: 2026-02-12
• Last updated: 2026-04-17

Locations

5 sites across 3 countries: Japan, South Korea, Taiwan

Regulatory

• FDA-regulated drug study