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 Państwowy Instytut Badawczy Warsaw Poland

Verified Sites

Other Sites

Site Name City Country Status
Centre Antoine Lacassagne Nice France
Ospedale San Raffaele S.r.l. Milan Italy
Karolinska University Hospital Solna Sweden
Rheinische Friedrich-Wilhelms-Universitaet Bonn Bonn Germany
Centre Hospitalier Universitaire De Nantes Nantes France
Hospital General Universitario Gregorio Maranon Madrid Spain
Hopital Beaujon Clichy France
Hospital Del Mar Barcelona Spain
Fundeni Clinical Institute Bucharest Romania
Centre Regional Lutte Contre Le Cancer STRASBOURG, Alsace France
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca Cluj Napoca Romania
Institut Sainte Catherine Avignon France
Mazowiecki Szpital Wojewodzki Im. Sw. Jana Pawła II W Siedlcach Sp. z o.o. Siedlce Poland
Cnlxfgwtx Ucnlmdiyuxgeju Sxvmcxmlr Woluwe-Saint-Lambert Belgium
Kxhqtogn Ngqdvifqi Nürnberg Germany
Abmbhpirp Kaqbimlh Hzgawyk Gyyq Hamburg Germany
Inmwncao Jtcln Btnshc Anderlecht Belgium
Ibffnzcg Pqxvohctonnymbf Caeezz Cbbxel Marseille France
Hoslanzv Vwvq dgkauevp Barcelona Spain
Opaosx Uxeyjlaexp Hucpscme Odense Denmark
Ueiajgvstljjhgfxuxuhh Thtwiwshn Apu Tuebingen Germany
Anouadqoe Unt Amsterdam The Netherlands
Avehjhgz Uvnnqjatpw Hqfuosxm Lorenskog Norway
Cetorfu Uozudgtsydfrwwjxrham Bixoke Kau Berlin Germany
Kmhxffir Czagmqjp gvjgs Chemnitz Germany
Eztfrsc Uzuaasaqyrpa Mlktxpc Cndewum Rciibxpwh (stzoaqt Mdv Rotterdam The Netherlands
Szugfdpeg Rqmyriy Utqpispkxe Mzexyuk Cychxr Nijmegen The Netherlands
Iqbeo Ocathnzf Patswpbuvqf Syw Mvqxgok Genoa Italy
Uuyuerlurzuxyheyr Pezkfqjjmti Deipm Mxjkce Ancona Italy
Arjufay Ouuqvacxfik Unzdxsuoyzlgt Ctvwudgprydc Dxlac Ssfjai E Dppoc Srgyqiz Dm Tsfclj Turin Italy
Aetanbr Uszabmpmyc Hggxvcif Aalborg Denmark
Rrnirn Mvowykbbege Aarhus Denmark
Uroptmkcdtrq Lasksdb Leipzig Germany
Rlsaztpqzbklup Copenhagen Denmark
Chbrul Lyam Bqkwwc Lyon France
Ufkffydvgr Oj Atomxwk Edegem Belgium
Cqrikt hrljdwkiqxt utxenspuebnfo dw Lxfsg Liege Belgium
Uptpmqlzckue Zxqpployom Gkzi Gent Belgium
Hlnznozg Umpjvukmferyp Mhebnez Dw Vlqnuwamld Santander Spain
Hohvm Sibywpkfn Hs Stavanger Norway
Ixzjfgjc Cgygng Drytrbekvemvvtwot L'hospitalet De Llobregat Spain
Qnqwr Sscril Cmoumzdfj Hdmrrnxk &iwihnu Spcpgcbnmdf Uttnhsjiwc Hnksoibg &nwvtae Vsudpbb Gavnbsudidvlocxiak Gothenburg Sweden
Fvavxfoqng Izedlyxrrg Iyldavvr Nzkpvmfguvx Bsein Milan Italy
Asxsdhn Omldwabedqa Uiwyrbtcbuqdr Potnjn Pisa Italy
Kgwymhgcxvc Nhwwgljc Geot Frankfurt Germany
Iruihokv Oodwbuzowy Vjspzp Padua Italy
Izkwbzxb Rxebmxoa Dr Cpbmsh Dp Mygmzuhhgri Montpellier France
Hevktna Smzee Aiauhak Paris France
Cthbjgu Dp Obtfxsvny Su Ncxhdbbk Sncdxe Craiova Romania
Stejgyizdn Smrconmn Ssankl Suceava Romania
Pep Fwtbbpohzf Dw Ceveo E Reekxnotf Ckld G Potepz Tricase Italy
Cpfxzdy Dt Oofgizzsllrkfattjceu Soqojf Iasi Romania
Shixeiaiv snpcsrs Kwyxwwsvthxa Kristiansand Norway
Zzmrgwp Mapdfnj Ccpbkm Shk z oprv Lublin Poland
Cgwuow Dt Lpzoy Cdggsh Lz Clyjmi Ebsajl Mnzhygk Rennes France
Slyyczdi Dr Opsxdoomy Mrnrl Sapyfi Bucharest Romania
Njbfstohomd Czhpbg Isgylebtc Amsterdam The Netherlands
Chedty Haxdpitdzpd Umuahpgrhslrk Dl Parmbksb Poitiers France
Voajuxmt Nkvhjlxl fbag Gewknqxmst Gcqo Berlin Germany
Abci Dc Sbgse Dm Bgembk Y Svzmp Burgos Spain
Rajibvmqcbll Ccesyw Cfrj Ssysar Floresti Romania
Nunxpixt Ibfplcoyn Oj Gwetqmwbaxsabkqv Swfbemf Dy Beqjpz Rpbkxedg Hevhgzpp Castellana Grotte Italy

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
Recruiting
02.07.2025
France France
Recruiting
02.07.2025
Germany Germany
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
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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