Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
NCT07405151

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

Led by Merck Sharp & Dohme LLC · Updated on 2026-05-01

60

Participants Needed

7

Research Sites

115 weeks

Total Duration

On this page

Sponsors

M

Merck Sharp & Dohme LLC

Lead Sponsor

D

Daiichi Sankyo

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Has a confirmed diagnosis of unresectable locally advanced or metastatic esophageal squamous cell carcinoma (ESCC)
  • Has disease progression after 1 or 2 prior systemic therapy treatments for ESCC
  • Has measurable disease
  • If infected with HIV, has well-controlled HIV on antiretroviral therapy
  • Has adequate organ function
Not Eligible

You will not qualify if you...

  • Has adenocarcinoma or adenosquamous carcinoma subtype
  • Has uncontrollable pleural effusion, pericardial effusion, or ascites needing frequent drainage or medical intervention
  • Has clinically significant corneal disease
  • Had cerebrovascular accident, transient ischemic attack, or other arterial thromboembolic event within 6 months before screening
  • If infected with HIV, has history of Kaposi's sarcoma or Multicentric Castleman's Disease
  • Has uncontrolled or significant cardiovascular disease
  • Has another progressing malignancy requiring active treatment within the past 3 years
  • Has active central nervous system metastases or carcinomatous meningitis
  • Has history or current pneumonitis/interstitial lung disease or suspected pneumonitis/interstitial lung disease
  • Has active infection requiring systemic therapy other than allowed
  • Has severe lung problems from illnesses such as pulmonary emboli, severe asthma, severe COPD, restrictive lung disease, pleural effusion, autoimmune or inflammatory disorders, prior pneumonectomy, or needs supplemental oxygen

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 7 locations

1

Aichi Cancer Center ( Site 2702)

Nagoya, Aichi-ken, Japan, 464-8681

Actively Recruiting

2

Kanagawa Cancer Center ( Site 2701)

Yokohama, Kanagawa, Japan, 241-8515

Actively Recruiting

3

National Cancer Center Hospital ( Site 2700)

Chūō, Tokyo, Japan, 104-0045

Actively Recruiting

4

Asan Medical Center ( Site 2901)

Seoul, South Korea, 05505

Actively Recruiting

5

Samsung Medical Center ( Site 2900)

Seoul, South Korea, 06351

Actively Recruiting

6

Hopitaux Universitaires de Geneve HUG ( Site 3701)

Geneva, Switzerland, 1211

Actively Recruiting

7

National Cheng Kung University Hospital ( Site 3001)

Tainan, Taiwan, 704

Actively Recruiting

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Research Team

T

Toll Free Number

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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