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

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What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

Site Name City Country Status
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy Warsaw Poland

Verified Sites

Other Sites

Site Name City Country Status
Klinikum Nuernberg Nürnberg Germany
Asklepios Kliniken Hamburg GmbH Hamburg Germany
Centre Antoine Lacassagne Nice France
Institut Jules Bordet Anderlecht Belgium
Odense University Hospital Odense Denmark
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Ospedale San Raffaele S.r.l. Milan Italy
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Karolinska University Hospital Solna Sweden
Klinikum Chemnitz gGmbH Chemnitz Germany
Stichting Radboud University Medical Center Nijmegen The Netherlands
IRCCS Ospedale Policlinico San Martino Genoa Italy
Universita’ Politecnica Delle Marche Ancona Italy
Aalborg University Hospital Aalborg Denmark
Rheinische Friedrich-Wilhelms-Universitaet Bonn Bonn Germany
Centre Hospitalier Universitaire De Nantes Nantes France
Region Midtjylland Aarhus Denmark
Rigshospitalet Copenhagen Denmark
Centre hospitalier universitaire de Liege Liege Belgium
Universitair Ziekenhuis Gent Gent Belgium
Hospital General Universitario Gregorio Maranon Madrid Spain
Hopital Beaujon Clichy France
Hospital Del Mar Barcelona Spain
Helse Stavanger HF Stavanger Norway
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen Gothenburg Sweden
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Azienda Ospedaliero Universitaria Pisana Pisa Italy
Fundeni Clinical Institute Bucharest Romania
Krankenhaus Nordwest GmbH Frankfurt Germany
Istituto Oncologico Veneto Padua Italy
Hopital Saint Antoine Paris France
Centrul De Oncologie SF Nectarie S.R.L. Craiova Romania
Sigmedical Services S.R.L. Suceava Romania
Pia Fondazione Di Culto E Religione Card G Panico Tricase Italy
Centrul De Oncologie-Euroclinic S.R.L. Iasi Romania
Sørlandet sykehus Kristiansand Kristiansand Norway
Zanamed Medical Clinic Sp. z o.o. Lublin Poland
Centre Regional Lutte Contre Le Cancer STRASBOURG, Alsace France
Centre De Lutte Contre Le Cancer Eugene Marquis Rennes France
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca Cluj Napoca Romania
Spitalul De Oncologie Monza S.R.L. Bucharest Romania
Netherlands Cancer Institute Amsterdam The Netherlands
Centre Hospitalier Universitaire De Poitiers Poitiers France
Vivantes Netzwerk fuer Gesundheit GmbH Berlin Germany
Area De Salud De Burgos Y Soria Burgos Spain
Radiotherapy Center Cluj S.R.L. Floresti Romania
National Institute Of Gastroenterology Saverio De Bellis Research Hospital Castellana Grotte Italy
Institut Sainte Catherine Avignon France
Mazowiecki Szpital Wojewodzki Im. Sw. Jana Pawła II W Siedlcach Sp. z o.o. Siedlce Poland
Cmjswbcjj Usvkkmghwfwaks Sykyvdvdy Woluwe-Saint-Lambert Belgium
Iqocdyre Ppopjmesrvjtaoz Cjuqbo Ckrpoq Marseille France
Hkfapptx Vusc doczywtj Barcelona Spain
Auqbcwmxt Utt Amsterdam The Netherlands
Abtyvlqd Udcvmcagba Hyrerzbt Lorenskog Norway
Efasswq Uxzxrsjjxctr Mdqmcoy Cwzvscx Rlronngat (hlktrss Mwz Rotterdam The Netherlands
Akvddau Ozimivivvpo Uddxipzzyrczv Ccspkeqegqdi Djgou Smtiyi E Dfzco Szkuiws Db Twhmkb Turin Italy
Ckqgfj Lptu Boceic Lyon France
Umejooymev Oy Apfiaki Edegem Belgium
Hbmyfznb Uskceoersymcn Mgurtsw Do Vopekoayav Santander Spain
Idjkjlab Cuthij Dosmztldzcfrudnoi L'hospitalet De Llobregat Spain
Iuvzrjfs Rznighye Dc Cqhyre Dz Mddprdlhbjy Montpellier France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Recruiting
02.07.2025
Denmark Denmark
Not yet recruiting
02.07.2025
France France
Recruiting
02.07.2025
Germany Germany
Not yet recruiting
02.07.2025
Italy Italy
Recruiting
02.07.2025
Norway Norway
Not yet recruiting
02.07.2025
Poland Poland
Recruiting
02.07.2025
Romania Romania
Recruiting
02.07.2025
Spain Spain
Recruiting
02.07.2025
Sweden Sweden
Not yet recruiting
02.07.2025
The Netherlands The Netherlands
Not yet recruiting
02.07.2025

Trial locations

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.

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 ID:
2023-509630-19-00
Protocol code:
DS7300-202
NCT ID:
NCT06644781
Trial Phase:
Therapeutic confirmatory (Phase III)

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