RecruitingPHASE1INTERVENTIONAL

A Study of Subcutaneous Trastuzumab Deruxtecan in Participants With Metastatic Solid Tumors

This study is looking at a new way to give a cancer medicine called Trastuzumab Deruxtecan (also known as T-DXd). Normally, this drug is given through a drip into a vein. In this study, doctors want to see if giving it as an injection under the skin (subcutaneous) is just as safe and effective for people with solid cancers that have spread or come back. The study will also check how the body handles the medicine and what dose works best. This new injection method could be more convenient and comfortable for patients than regular drips. The main goal is to find out if this under-the-skin injection is a good option for treating various advanced solid tumours.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

Daiichi Sankyo

Enrolment target

Start

17 Jul 2025

Estimated completion

31 Dec 2028

Recurrent or Metastatic Solid Tumors

What is this study about?

This study is like a detailed look at a new way to give an existing cancer medicine called Trastuzumab Deruxtecan (you might hear it called T-DXd). Currently, this powerful drug is usually given through a slow drip into a vein in your arm, which means spending time in a clinic. The research team wants to find out if giving this medicine as a simple injection under the skin, similar to how some diabetes medicines are given, is a good idea. This could make getting your treatment much easier and more comfortable, allowing you more freedom.

The main aim of this study is to carefully check a few important things. Firstly, they want to make sure the under-the-skin injection is safe and doesn't cause too many side effects (this is called 'safety' and 'tolerability'). Secondly, they'll be looking at how your body absorbs and uses the medicine when it's given this new way, to make sure it works just as well as the drip version. Finally, they'll be observing if the treatment helps to shrink or control the cancer (this is called 'efficacy').

This research is happening in two main parts: first, they'll gradually increase the dose of the medicine to find the best amount to give, and then they'll expand the study to include more people with different types of solid tumours to get a clearer picture of how well it works across various cancers that have returned or spread. It's an important step in potentially improving how patients receive their cancer treatment in the future.

Key takeaways

This study is testing a new way to give an existing cancer drug – as an injection under the skin.
It's for adults with solid cancers that have spread or come back after previous treatments.
The main goals are to check safety, how the body uses the drug, and if it helps control the cancer.
This new injection method could make treatment more convenient than traditional drips.
You'll need specific cancer test results and previous treatment history to be considered.

Who may be eligible?

The study needs adult participants, aged 18 or over. You must be able to understand the study and agree to take part by signing a consent form. You will also need to have a type of cancer called a 'solid tumour' that has either come back or spread to other parts of your body.

For most types of breast cancer, you'll need to have had specific previous treatments. For example, if your breast cancer is HER2-positive, you would usually have already received a HER2-targeted treatment. If your breast cancer is HER2-low, you might have had chemotherapy or hormone therapy previously. The key is that your cancer has progressed or returned after earlier treatments.

The research team will need to check your exact cancer type and your past treatments very carefully to make sure you fit all the detailed requirements for the study. They will also need recent test results confirming your cancer's characteristics, especially if your cancer needs to be HER2-positive or HER2-low to qualify.

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 an adult aged 18 or older?
Do you have a solid tumour that has spread or returned?
Have you had previous cancer treatments?
Do you have recent test results for your cancer showing things like HER2 status?
Are you able to attend regular clinic appointments?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be giving the study medicine as an injection under your skin, rather than through a drip. The study team will explain everything and make sure you're comfortable. You'll have regular visits to the clinic so the doctors can check how you're feeling, monitor for any side effects, and see how well the treatment is working. This will involve physical exams, blood tests, and scans. The exact number of visits and the full duration of your participation will depend on which part of the study you are in and how you respond to the treatment, but it will involve ongoing check-ups for a period of time.

Potential risks and benefits

Taking part in any study has potential benefits and risks. You might benefit from receiving a new treatment approach that could be more convenient and potentially effective for your cancer, but there's no guarantee the treatment will work for you. There is always a risk of side effects from any medication, and the study team will closely monitor you for these. You will be fully informed of all known side effects before you decide to join. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (26)

Research Site
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Newport Beach, United States· Recruiting
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Atlanta, United States· Recruiting
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Las Vegas, United States· Recruiting
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Charlotte, United States· Recruiting
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Maumee, United States· Recruiting
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Nashville, United States· Recruiting
Research Site Saint
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Herblain, France· Recruiting
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Rennes, France· Recruiting
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Chiba, Japan· Recruiting
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Kanagawa, Japan· Recruiting
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Tokyo, Japan· Recruiting
Research Site
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Tokyo, Japan· Recruiting

Common questions

What does 'subcutaneous' mean?

It means 'under the skin'. So, the medicine is given by an injection just under your skin, like a small jab.

What is Trastuzumab Deruxtecan?

It's a cancer medicine that is already approved for some cancers, and helps target cancer cells.

What is a 'solid tumour'?

A solid tumour is a lump of cancer cells, rather than cancers that affect blood cells, for example.

Will I get a placebo (dummy treatment) in this study?

No, this study is testing different doses of the active medicine, not comparing it to a placebo.

Who is funding this research?

This study is sponsored and funded by Daiichi Sankyo, Inc., a pharmaceutical company.

How to find out more

Contact for Trial Information

ctrinfo_us@daiichisankyo.com 908-992-6400 Official trial record

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