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Study of Ifinatamab Deruxtecan and Chemotherapy for Patients with Advanced or Metastatic Esophageal Squamous Cell Carcinoma

Verified siteRegistered drugNo 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 focused on studying a type of cancer called Esophageal Squamous Cell Carcinoma (ESCC), which affects the esophagus, the tube that carries food from the mouth to the stomach. The study is testing a new treatment called Ifinatamab deruxtecan, also known by its code name DS-7300a. This treatment is an antibody-drug conjugate (ADC), which is a special type of medicine designed to target and kill cancer cells. The trial will compare this new treatment to other chemotherapy options chosen by doctors, such as Docetaxel, Irinotecan Hydrochloride, and Paclitaxel.

The purpose of the study is to see if Ifinatamab deruxtecan can help people with advanced or metastatic ESCC live longer compared to the other chemotherapy treatments. Participants in the study will receive the treatment through an intravenous infusion, which means the medicine is given directly into a vein. The study will last for a period of up to 54 weeks, during which participants will be closely monitored by healthcare professionals. The study will also look at how the treatment affects the quality of life and any side effects that may occur.

Throughout the study, participants will undergo regular check-ups and imaging tests like computed tomography (CT) or magnetic resonance imaging (MRI) to track the progress of the disease. The study aims to provide valuable information on the effectiveness and safety of Ifinatamab deruxtecan for treating ESCC, potentially offering a new option for patients with this challenging condition.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, you will be randomly assigned to receive either the new treatment, ifinatamab deruxtecan, or one of the standard chemotherapy options: docetaxel, irinotecan hydrochloride, or paclitaxel.

    The assignment is random to ensure fairness and accuracy in the study results.

  2. Step 2

    Treatment administration

    The treatment will be administered through an intravenous infusion, which means the medication will be given directly into your vein.

    The frequency and dosage of the medication will depend on the specific treatment you are assigned to. This will be explained to you in detail by the medical team.

  3. Step 3

    Monitoring and assessments

    Throughout the study, regular monitoring will be conducted to assess your health and the effectiveness of the treatment.

    This will include imaging tests like CT or MRI scans to measure the size of the tumor, as well as blood tests and other evaluations to monitor your overall health.

  4. Step 4

    Reporting side effects

    You will be asked to report any side effects or changes in your health to the study team. This is important for ensuring your safety and adjusting the treatment if necessary.

    The study team will provide guidance on what to look out for and how to report any issues.

  5. Step 5

    Completion of the study

    The study is expected to continue until December 2028, but your participation may end earlier depending on your health and the study's progress.

    At the end of your participation, a final assessment will be conducted to evaluate the overall impact of the treatment on your condition.

Who can join the trial?

6 criteria

  • Participants must be at least 18 years old. If the legal age for consent is higher in your area, that age applies.
  • Participants must have a confirmed diagnosis of unresectable locally advanced or metastatic Esophageal Squamous Cell Carcinoma (ESCC). "Unresectable" means the cancer cannot be removed with surgery.
  • Participants must have experienced disease progression after receiving platinum-based and immune checkpoint inhibitor (ICI) treatments. This means the cancer has worsened despite these treatments, and only one previous line of systemic therapy for advanced or metastatic ESCC is allowed.
  • Participants must provide a tumor sample that is adequate in both quantity and quality for the study.
  • Participants must have at least one measurable lesion on a CT or MRI scan, as determined by the study doctor. A lesion is an area of abnormal tissue.
  • Participants must have an ECOG Performance Status of 0 or 1 within 7 days before starting the study. This is a scale used to assess how a patient's disease is progressing, including their level of functioning and ability to care for themselves.

Who cannot join the trial?

7 criteria

  • Patients with any other type of cancer besides Esophageal Squamous Cell Carcinoma (ESCC) cannot participate.
  • Patients who have received certain treatments for ESCC that the study does not allow cannot participate.
  • Patients with severe or uncontrolled medical conditions that could interfere with the study cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have participated in another clinical trial recently may not be eligible.
  • Patients with known allergies to the study drugs or similar drugs cannot participate.
  • Patients who are unable to comply with the study procedures and follow-up visits cannot participate.
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Investigated drugs

Ifinatamab Deruxtecan (I-DXd) is a medication being studied for its potential to treat advanced or metastatic esophageal squamous cell carcinoma, which is a type of cancer that affects the esophagus. This medication is designed to target and deliver a cancer-fighting agent directly to the cancer cells, which may help to stop or slow down the growth of the cancer. The goal of using this medication in the trial is to see if it can help patients live longer compared to other chemotherapy treatments chosen by their doctors.

What is already known about the treatment

Ifinatamab Deruxtecan (I-DXd) – This medication is administered through an intravenous infusion, meaning it is given directly into the bloodstream through a vein. It is currently being studied in clinical trials for its effectiveness in treating advanced or metastatic esophageal squamous cell carcinoma (ESCC), a type of cancer that affects the esophagus. The main goal of the study is to see if this medication can help patients live longer compared to standard chemotherapy treatments. At the molecular level, Ifinatamab Deruxtecan works by targeting specific proteins on cancer cells, delivering a toxic substance that helps to kill these cells. It is classified as an antibody-drug conjugate, which is a type of targeted cancer therapy.

Investigated diseases

Esophageal Squamous Cell Carcinoma – Esophageal Squamous Cell Carcinoma is a type of cancer that forms in the squamous cells lining the esophagus. It typically begins as a small lesion or ulcer in the esophagus and can grow to obstruct the passage of food. As the disease progresses, it may invade deeper layers of the esophageal wall and spread to nearby lymph nodes and other organs. Symptoms often include difficulty swallowing, chest pain, and weight loss. The progression of the disease can lead to complications such as esophageal obstruction or bleeding. It is more common in certain regions and populations, often linked to lifestyle factors such as smoking and alcohol consumption.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-509630-19-00Protocol codeDS7300-202Estimated enrolment510 patientsSponsorDaiichi Sankyo Inc.

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