RecruitingPHASE3INTERVENTIONAL

A Study of Ifinatamab Deruxtecan in Subjects With Pretreated Advanced or Metastatic Esophageal Squamous Cell Carcinoma (ESCC) (IDeate-Esophageal01)

This study is testing a new medicine called ifinatamab deruxtecan for people who have a type of advanced oesophageal cancer called squamous cell carcinoma. This is for patients whose cancer has already been treated with certain chemotherapy and immunotherapy drugs, but has since grown. We want to find out if this new drug can help people live longer and if their cancer can be kept under control for longer, compared to standard chemotherapy chosen by their doctor. We'll also be looking at how safe the new drug is and if it shrinks the cancer. The study aims to offer a new treatment option for those who have limited choices left.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Daiichi Sankyo

Enrolment target

510

Start

27 Mar 2025

Estimated completion

01 Nov 2029

Esophageal Squamous Cell Carcinoma

What is this study about?

This research study is focused on a specific type of oesophageal (food pipe) cancer called squamous cell carcinoma. This cancer is considered 'advanced' or 'metastatic' because it has either spread to other parts of the body or can't be removed with surgery. We're particularly interested in people whose cancer has already been treated with standard platinum-based chemotherapy and another type of drug called an immune checkpoint inhibitor, but unfortunately, their cancer has continued to grow.

The main goal of this study is to compare a new drug, called ifinatamab deruxtecan, with chemotherapy treatments that doctors usually choose in these situations. We want to see if the new drug can help people live longer than if they were to receive standard chemotherapy. We'll also be checking if the new drug can stop the cancer from growing for a longer time and if it can shrink the tumours.

Understanding how safe this new drug is and what side effects it might cause is also a very important part of this study. By comparing it directly to existing treatments, we hope to find a better and safer option for people living with this challenging type of cancer, especially when other treatments haven't worked as well as hoped.

Key takeaways

This study tests a new drug for advanced oesophageal cancer.
It's for people whose cancer grew after previous chemotherapy and immunotherapy.
The new drug is compared to standard chemotherapy.
The main goals are to see if people live longer and if their cancer is controlled better.
Safety and side effects of the new drug will be carefully checked.
Participation involves regular hospital visits, tests, and scans.

Who may be eligible?

To join this study, you need to be at least 18 years old and have been diagnosed with advanced oesophageal squamous cell carcinoma. Your cancer must have already been treated with platinum-based chemotherapy and an immune checkpoint inhibitor, and it must have grown since these treatments. You can only have had one previous treatment for your advanced cancer.

We will need to check some of your cancer tissue samples to make sure there's enough to test. Your health and ability to do daily activities will also be checked, and you should be generally well. Your doctor will need to see at least one measurable spot of cancer on scans like CT or MRI that can be tracked throughout the study.

There are also some reasons why you might not be able to join. For example, if you've already received a similar type of drug to the new one being tested, or if you have certain other serious medical conditions. If your cancer has grown into nearby organs in a way that could cause bleeding or other serious problems, you might not be eligible. Your doctor will carefully review all the criteria to see if this study is right for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have advanced oesophageal squamous cell carcinoma?
Has your cancer been treated with a platinum-based chemotherapy and an immune checkpoint inhibitor, and has it grown since then?
Have you had no more than one previous treatment for your advanced cancer?
Are you generally well and able to carry out most daily activities?
Do you not have certain other serious health problems or types of cancer?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be given either the new study drug, ifinatamab deruxtecan, or one of the standard chemotherapy drugs chosen by your doctor (like docetaxel, paclitaxel, or irinotecan). Which treatment you receive is decided by chance, like flipping a coin. You will have regular hospital visits for treatments, blood tests, and scans (like CT or MRI) to check how the treatment is working and monitor for any side effects. These scans will help us see if your cancer is shrinking or staying stable. The length of time you receive treatment will depend on how you respond to the drug and if you experience any serious side effects. After your treatment finishes, you will have follow-up visits or phone calls to continue monitoring your health for a period of time. The total duration of your participation, including follow-up, could be for several months or longer.

Potential risks and benefits

Taking part in any clinical trial comes with potential benefits and risks. You might benefit from the new drug if it works better than standard treatments, potentially helping to control your cancer for longer or improving your quality of life. However, there's no guarantee the new drug will work for you, and you may experience side effects, some of which could be serious. The doctors and nurses will monitor you very closely for any side effects and will do their best to manage them. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (132)

Mayo Clinic Hospital
Verified postcode
Phoenix, United States· Recruiting
Providence Medical Foundation
Verified postcode
Fullerton, United States· Recruiting
Univ of California Irvine College of Medicine
Verified postcode
Orange, United States· Recruiting
Henry Ford Health System
Verified postcode
Detroit, United States· Recruiting
Mayo Clinic Rochester
Verified postcode
Rochester, United States· Recruiting
MidAmerica Cancer Care - American Oncology Partners
Verified postcode
Kansas City, United States· Recruiting
Morristown Medical Center
Verified postcode
Morristown, United States· Recruiting
Maimonides Cancer Center
Verified postcode
Brooklyn, United States· Recruiting
Penn State University Milton S. Hershey Medical Center
Verified postcode
Hershey, United States· Recruiting
Baptist Cancer Center
Verified postcode
Memphis, United States· Recruiting
SCRI Oncology Partners
Verified postcode
Nashville, United States· Recruiting
John Peter Smith Hospital
Verified postcode
Fort Worth, United States· Recruiting

Common questions

What is oesophageal squamous cell carcinoma?

It's a type of cancer that starts in the lining of your food pipe (oesophagus) and is made up of flat cells called squamous cells.

What does 'advanced or metastatic' mean?

This means the cancer has either spread from where it started to other parts of your body or it's grown into nearby areas and can't be removed by surgery.

What is an 'immune checkpoint inhibitor'?

This is a type of immunotherapy drug that helps your own immune system recognise and fight cancer cells.

Will I definitely get the new drug?

No, you might receive the new drug or one of the standard chemotherapy treatments. Which one you get will be decided by chance, like drawing lots.

What if the treatment isn't working or I feel unwell?

Your doctors will regularly check how you're responding and how you're feeling. If the treatment isn't helping or causes too many side effects, it can be stopped.

How to find out more

Daiichi Sankyo Contact for Clinical Trial Information

ctrinfo_us@daiichisankyo.com 9089926400 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.