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Ifinatamab deruxtecan in Patients With Advanced Esophageal Squamous Cell Carcinoma

Verified siteInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is being done in esophageal squamous cell carcinoma, a type of esophageal cancer that starts in the lining of the food pipe. The study is testing ifinatamab deruxtecan, a medicine given by intravenous infusion, meaning it is delivered slowly into a vein. The purpose of the study is to see how well this treatment works in people with advanced disease that cannot be removed with surgery or has spread to other parts of the body.

People in the study receive ifinatamab deruxtecan over time during regular treatment visits. The study is open-label, which means both the study team and the participant know which treatment is being given. The course of the study includes treatment and follow-up visits to watch for side effects and to see how long any benefit lasts. The study also looks at how long people live without the cancer getting worse and how many side effects happen during treatment.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Study treatment period

    After joining the study, you receive ifinatamab deruxtecan as an intravenous infusion, which means it is given through a vein.

    The dose is 12 mg/kg (milligrams per kilogram of body weight).

    The medicine is given once every 3 weeks.

    This treatment continues during the study period until the trial ends or the treatment is stopped for another reason, as described in the study plan.

  2. Step 2

    Study assessment period

    During the trial, your cancer is checked to see whether it responds to the medicine.

    The main result measured is objective response rate (ORR), which means the number of participants whose cancer gets smaller or disappears.

    The study also measures how long the response lasts, how long the cancer stays under control before it gets worse, how long participants live, and whether any side effects happen.

    The study also records whether any side effect causes you to stop the study treatment.

  3. Step 3

    End of trial period

    The trial is planned to continue until the study end date of 2027-09-09.

    At that time, the study treatment and study assessments end according to the trial plan.

Who can join the trial?

6 criteria

  • Has esophageal squamous cell carcinoma that is confirmed by a tissue test or cell test. This means the diagnosis was proven by looking at tissue or cells under a microscope.
  • Has unresectable locally advanced or metastatic disease. Unresectable means it cannot be removed safely with surgery. Locally advanced means it has grown nearby. Metastatic means it has spread to other parts of the body.
  • Has had the cancer get worse after 1 or 2 prior lines of systemic therapy. Systemic therapy means treatment that travels through the whole body, such as medicine given into a vein or taken by mouth.
  • Has measurable disease, meaning the tumors or cancer areas can be measured on scans or exams.
  • If the patient has HIV, the HIV must be well controlled with antiretroviral therapy. This means the HIV medicines are keeping the infection under control.
  • Has adequate organ function, meaning the main organs are working well enough for study treatment. This usually includes organs such as the liver, kidneys, and bone marrow, which makes blood cells.

Who cannot join the trial?

13 criteria

  • Has a tumor type other than esophageal squamous cell carcinoma, such as adenocarcinoma or adenosquamous carcinoma. These are different cancer cell types under the microscope.
  • Has an active infection that needs treatment throughout the body, except for infections that are allowed by the study.
  • Has serious lung problems that affect breathing, including recent blood clot in the lung, severe asthma, severe chronic obstructive pulmonary disease (a long-term lung disease that makes breathing difficult), restrictive lung disease, fluid around the lung, or lung problems related to autoimmune or inflammatory diseases such as rheumatoid arthritis, Sjögren’s syndrome, or sarcoidosis.
  • Has had a pneumonectomy, which means removal of one whole lung, or needs supplemental oxygen to breathe.
  • Has fluid buildup around the lungs, around the heart, or in the abdomen that cannot be controlled and needs frequent drainage or other medical treatment.
  • Has significant corneal disease, meaning an important eye condition affecting the clear front part of the eye.
  • Has had a stroke, transient ischemic attack (a brief stroke-like episode), or another arterial blood clot within 6 months before screening.
  • If living with HIV, has a history of Kaposi’s sarcoma or Multicentric Castleman’s disease, which are certain diseases linked to HIV.
  • Has heart or blood vessel disease that is not controlled or is considered significant.
  • Has another cancer that is known to be growing or has needed active treatment within the past 3 years.
  • Has active cancer spread to the brain or spinal fluid, including carcinomatous meningitis (cancer cells in the fluid around the brain and spinal cord).
  • Has ever had interstitial lung disease or pneumonitis (lung inflammation), no matter whether steroids were used, except for a past case of radiation pneumonitis that did not need steroids.
  • Has a current diagnosis of interstitial lung disease, or has signs on symptoms or imaging that suggest it, and the diagnosis cannot be ruled out.
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Investigated drugs

Ifinatamab deruxtecan is the study medicine being tested in this trial. It is given through a vein as an infusion, which means it goes directly into the bloodstream. The goal of the trial is to see how well it works for people with advanced esophageal cancer that cannot be removed with surgery, especially by checking whether it helps shrink or control the cancer.

What is already known about the treatment

Ifinatamab Deruxtecan - Ifinatamab deruxtecan is given as a solution for infusion through a vein, usually by intravenous infusion in a clinic or hospital. It is an investigational cancer medicine, meaning it is still being studied and is not yet a standard treatment in routine medical practice, but it has been reported in medical literature as a targeted anticancer drug. It is being developed for cancers such as esophageal squamous cell carcinoma, and it belongs to a class of medicines called antibody-drug conjugates, which are designed to carry a cancer-killing drug directly to tumor cells. It works by attaching to a specific target on cancer cells, entering the cell, and then releasing its active drug inside the cell to damage the cell’s DNA and help stop the cancer from growing.

Investigated diseases

Esophageal squamous cell carcinoma - Esophageal squamous cell carcinoma is a cancer that begins in the flat cells lining the inside of the esophagus, the tube that carries food from the throat to the stomach. It usually starts as a small abnormal growth in the esophageal lining and can gradually spread deeper into the wall of the esophagus. As it grows, it may narrow the passage and extend to nearby tissues or other parts of the body.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2026-525213-31-00Protocol codeMK-3475-06FEstimated enrolment60 patientsSponsorMerck Sharp & Dohme LLC

sourced from the EU Clinical Trials Register and site verification

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