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

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMerck Sharp & Dohme LLC

About this trial

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.

Eligibility criteria

Qualifiers

Has a histologically or cytologically confirmed diagnosis of unresectable locally advanced or metastatic esophageal squamous cell carcinoma (ESCC)

Has disease progression after 1 or 2 prior lines of systemic therapy for unresectable locally advanced or metastatic ESCC

Has measurable disease

If infected with human immunodeficiency virus (HIV), has well-controlled HIV on antiretroviral therapy

Disqualifiers

Has histologically or cytologically confirmed adenocarcinoma or adenosquamous carcinoma subtype

Has uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage or medical intervention

Has clinically significant corneal disease

Has any of the following within 6 months before screening: cerebrovascular accident, transient ischemic attack, other arterial thromboembolic event

Trial design

Treatments tested in this trial

  • I-DXd
  • Rescue Medication

Treatment groups

60 Participants
are divided into 1 treatment group

Sponsors and collaborators

Merck Sharp & Dohme LLC

Lead sponsor

Daiichi Sankyo

Collaborator