RecruitingPHASE2INTERVENTIONAL

Optimal Methods to Characterize ADC Resistance in Solid Tumors and Identify Clinically Useful Biomarkers

This international study is looking into why certain modern cancer treatments, called Antibody-Drug Conjugates (ADCs), might stop working in patients with advanced breast, stomach, bladder, and non-small cell lung cancer. ADCs are a type of targeted therapy that has improved many lives, but sometimes the cancer becomes resistant to them. Researchers want to identify specific markers in your body that could help predict if an ADC will be effective or if new side effects might occur. By collecting biological samples and patient information, the study hopes to develop ways to better match individuals to the most effective ADC treatment and find methods to prevent or manage unwanted side effects, ultimately working towards more personalised cancer care.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

UNICANCER

Enrolment target

400

Start

14 Nov 2025

Estimated completion

01 Nov 2030

Advanced Breast Cancer Advanced Gastric Cancer Advanced Urothelial Cancer Advanced Non Small Cell Lung Cancer (NSCLC)

What is this study about?

You might be aware that cancer treatments are constantly improving. One newer type of treatment is called Antibody-Drug Conjugates, or ADCs for short. These are specially designed treatments that combine an 'antibody' (which acts like a guided missile to find cancer cells) with a powerful 'drug' (which kills the cancer cells). ADCs have already shown great promise in treating various cancers, helping many people live longer and better lives. They're becoming a really important tool in cancer care, and many more are being developed.

However, even with these clever treatments, cancer can sometimes find ways to become resistant, meaning the ADC stops working as well as it once did. Also, like all medicines, ADCs can sometimes cause side effects. This study is designed to help us understand why resistance happens and what causes these side effects. Researchers will be looking at tiny details within cancer cells and in the body that might give clues as to why an ADC works well for some but not others, or why side effects occur.

The main goal is to find 'markers' — these are like signposts within your body that could help doctors pick the very best ADC for you, specifically. Finding these markers could also help prevent or manage side effects, leading to a more personal and effective treatment plan. It’s all about making sure each patient gets the most out of these powerful new therapies.

Key takeaways

This study aims to improve ADC cancer treatments.
It focuses on understanding why ADCs sometimes stop working and what causes side effects.
Participants will have advanced breast, stomach, bladder, or lung cancer.
It involves providing biological samples (biopsies, blood) and completing questionnaires.
The goal is more personalised and effective cancer care in the future.

Who may be eligible?

To join this study, you must be at least 18 years old. You will need to have a confirmed diagnosis of advanced breast, stomach, bladder, or non-small cell lung cancer, and your doctor should believe that an ADC treatment (one that's already approved or available through a special programme) is suitable for you.

For the study, you'll need to have at least two areas of cancer, including one that can be easily measured and another area that a doctor can safely take a small sample (biopsy) from. This sample can't be from your bones or brain. You'll need to agree to have these small samples taken both before and after your ADC treatment. You should also be generally well enough to take part and follow the study instructions.

If you are a woman who could become pregnant or a man whose partner could become pregnant, you'll need to agree to use effective contraception during the study and for a period afterwards. Your doctor will assess your overall health, including how well your organs are working, to make sure taking part is safe 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 breast, stomach, bladder, or non-small cell lung cancer that your doctor thinks can be treated with an ADC?
Can you provide small tissue samples (biopsies) from your cancer, and blood samples?
Are you able to fill out questionnaires about how you are feeling?
Are you willing to use contraception if requested for the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will continue with your planned ADC cancer treatment as advised by your doctor. The main parts of your participation will involve collecting some biological samples and filling out questionnaires. Before your treatment starts and again after it, doctors will take small samples (biopsies) from your tumour. They will also collect blood samples at various times during the study. These samples will be used to look for the markers mentioned earlier.

You will also be asked to complete questionnaires. These are designed to gather information about your experiences with the treatment, including any side effects you might have noticed and how you are feeling generally. The study will last for the entire time you are receiving your ADC treatment and will also involve some follow-up. The total duration will depend on how long you are on the treatment and the follow-up schedule.

Potential risks and benefits

Taking part in this study might help us learn more about how ADCs work, which could benefit future cancer patients. While there isn't a direct promise that it will benefit you personally, the information gained could lead to better ways of using these treatments. The main risks involve the procedures for taking biopsies and blood samples, which can cause some discomfort, bruising, or a small risk of infection. You might also find the questionnaires time-consuming. You are free to withdraw from the study at any time without affecting your medical care.

Locations (1)

Gustave Roussy Cancer Center
Verified postcode
Villejuif, France· Recruiting

Common questions

What is an ADC?

An ADC (Antibody-Drug Conjugate) is a type of targeted cancer treatment that uses an antibody to deliver a powerful drug directly to cancer cells.

What kind of cancers is this study for?

This study is for people with advanced breast, stomach, bladder, or non-small cell lung cancer.

What will I have to do if I join?

You'll have biopsies and blood tests, and fill out questionnaires about how you're feeling and any side effects.

Will joining the study change my cancer treatment?

No, you will still receive your planned ADC treatment as decided by your doctor. The study is about collecting extra information.

Can I stop being part of the study at any time?

Yes, you can choose to leave the study whenever you want, and your medical care will not be affected.

How to find out more

Marjorie Mauduit

m-mauduit@unicancer.fr +33 6 30481792 Official trial record

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