Not yet recruitingPHASE2INTERVENTIONAL

MEDI5752 in Patients With Mature Tertiary Lymphoid Structures Solid Tumors.

This study, called MEDI5752, is a Phase 2 clinical trial looking into a new treatment for people with advanced solid tumors. The treatment, also named MEDI5752, is being tested to see how effective it is. We're interested in patients whose tumors have a specific feature called 'mature tertiary lymphoid structures'. The study has two groups: one for people who haven't had prior immunotherapy for their cancer, and another for those whose previous immunotherapy treatments (like PD-1/PD-L1 inhibitors) are no longer working. It's an open-label study, meaning both you and the study team will know you're getting the active drug. The goal is to collect more information on how well this treatment works in these specific patient groups.

At a glance

Status

Not yet recruiting

Phase

PHASE2

Sponsor

Institut Bergonié

Enrolment target

102

Start

01 Sep 2025

Estimated completion

01 Sep 2028

Advanced Solid Tumor

What is this study about?

This clinical trial is researching a new treatment called MEDI5752 for people with advanced solid tumors. Solid tumors are cancers that form a lump, unlike blood cancers. Advanced means the cancer has spread or cannot be removed through surgery. The main goal of this study is to find out how effective MEDI5752 is at treating these cancers.

Researchers are particularly interested in tumors that have something called 'mature tertiary lymphoid structures' (TLS). These are special collections of immune cells found within the tumor, and scientists believe they might help certain treatments work better. The study is divided into two main groups, or 'cohorts,' based on your past treatment. One group is for people who have not yet received a type of cancer treatment called immunotherapy. The other group is for those whose cancer initially responded well to immunotherapy, but the treatment has since stopped working because the cancer has grown.

This is a 'Phase 2' study, which means researchers are further evaluating the safety and effectiveness of a treatment that has already shown some promise in earlier studies. By participating, you could help doctors learn more about this potential new treatment for advanced solid tumors, especially in patients with these specific tumor features.

Key takeaways

This study is testing a new cancer treatment (MEDI5752) for advanced solid tumors.
It's for people whose tumors have specific immune cell collections (TLS).
There are two groups based on past immunotherapy treatment.
Participation involves regular clinic visits, tests, and closely monitoring your health.
You'll know you're getting the active drug (open-label study).

Who may be eligible?

To be considered for this study, you would need to have an advanced solid tumor that has been confirmed by a biopsy. A special test on your tumor tissue must show the presence of 'mature tertiary lymphoid structures'. Your cancer should also be measurable, meaning doctors can track its size and changes.

Depending on your past treatment, you would fit into one of two groups: either you haven't received immunotherapy before for your cancer, or you have had immunotherapy (like PD-1/PD-L1 inhibitors) and it worked well for at least four months but has now stopped being effective.

Other important requirements include being at least 18 years old, generally in good health, and having a good life expectancy. Your body's organs, like your heart, liver, and kidneys, need to be working properly. You should also be able to provide a tissue sample for research and agree to use effective contraception if needed.

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.

Do you have an advanced solid tumor confirmed by a biopsy?
Does your tumor have 'mature tertiary lymphoid structures'?
Are you either new to immunotherapy, OR did immunotherapy work for at least 4 months but has now stopped?
Are you at least 18 years old and generally in good health?
Are your major organs (heart, liver, kidneys) working well?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive the study treatment, MEDI5752. The study will involve regular visits to the clinic for check-ups, tests, and assessments to see how your body is reacting to the treatment and how your cancer is responding. These assessments will likely include blood tests, imaging scans to check your tumor, and potentially further biopsies for research purposes. You will be monitored closely throughout the treatment period. The overall duration of your participation in the study will depend on how you respond to the treatment and will be discussed in detail by the study team.

Potential risks and benefits

Taking part in this study may offer potential benefits, such as access to a new treatment that is not yet widely available. Your health will be closely monitored, which could lead to early detection of any changes. However, as with any new medication, there are potential risks and side effects, some of which may be serious, that will be fully explained to you by the study team. You always have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Institut Bergonie
Verified postcode
Bordeaux, France

Common questions

What is a 'solid tumor'?

A solid tumor is a type of cancer that forms a mass or lump of abnormal cells, unlike blood cancers which affect cells in the blood.

What does 'advanced' cancer mean in this study?

In this study, 'advanced' means the cancer has spread to other parts of the body (metastatic) or cannot be removed by surgery.

What are 'tertiary lymphoid structures'?

These are special collections of immune cells found within some tumors. Researchers believe they might affect how well certain cancer treatments work.

What is the difference between the two study groups?

One group is for people who haven't had immunotherapy for their cancer before. The other group is for those whose immunotherapy worked well initially but has now stopped working.

Will I know if I'm getting the study drug?

Yes, this is an 'open-label' study, meaning everyone, including you and the study team, will know you are receiving the treatment called MEDI5752.

How to find out more

Antoine ITALIANO, MD, PhD

a.italiano@bordeaux.unicancer.fr +33556333333 Official trial record

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