Ongoing, recruitingPhase I and Phase II (Integrated)- OtherInterventional

Trail aiming to assess the safety and clinical activity of bemarituzumab + bevacizumab in advanced/metastatic gynecological cancer overexpressing FGFR2b

Doctors are running a study to investigate a new treatment for advanced gynaecological cancer. The study is for women whose cancer cells make a lot of a protein called FGFR2b. This study is testing two medicines together: bemarituzumab and bevacizumab. The main goal is to find out if this combination is safe and if it helps to slow down or stop the cancer from growing. This is an early-stage study, meaning doctors are still learning about this treatment. It aims to see if the medicines can work well together to treat this specific type of gynaecological cancer.

At a glance

Status

Ongoing, recruiting

Phase

Phase I and Phase II (Integrated)- Other

Sponsor

Centre Leon Berard

Enrolment target

Start

08 Jul 2025

Advanced/metastatic gynecological cancer overexpressing FGFR2b

What is this study about?

This study is looking into a new way to treat certain advanced gynaecological cancers. Gynaecological cancers are those that affect a woman's reproductive organs, like the ovaries or uterus. When we say 'advanced' or 'metastatic,' it means the cancer has spread from where it started to other parts of the body.

The treatment being tested involves two different medicines: bemarituzumab and bevacizumab. These medicines work in specific ways. Bemarituzumab targets a particular protein called FGFR2b, which is found in higher amounts on some cancer cells. Bevacizumab works by stopping the cancer from forming new blood vessels, which it needs to grow. The idea is that using these two medicines together might be more effective than using just one.

This study is in its early stages (called Phase I and Phase II). This means that while doctors have done some lab tests, they are still gathering important information about how safe the treatment is for people and whether it shows promising results in fighting the cancer. The aim is to carefully introduce this new treatment and see how it affects patients.

Key takeaways

This study is for women with advanced gynaecological cancer.
The cancer must have high levels of a protein called FGFR2b.
It's testing a new combination of two medicines: bemarituzumab and bevacizumab.
The main goals are to check the treatment's safety and how well it helps control the cancer.
Participation involves regular hospital visits, treatments, and tests.
You can always choose to stop participating at any time.

Who may be eligible?

This study is for women aged 18 or older who have advanced gynaecological cancer. A key requirement is that your cancer cells must show an overexpression of a specific protein called FGFR2b. Your doctor will be able to tell you if your cancer has this specific feature, usually by testing a sample of your cancer tissue.

To join, you would also need to meet other health criteria to ensure it's safe for you to take part. This might include having certain blood test results or generally being well enough to receive treatment. The study team will review all your medical information carefully to see if this study is a good fit for you.

There might be reasons why you *cannot* join the study, even if you meet the main criteria. These could include having other serious health conditions, having had certain other cancer treatments recently, or being pregnant or breastfeeding. Your doctor and the study team will go through all these details with 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 a woman aged 18 or older?
Do you have advanced gynaecological cancer?
Has your doctor confirmed that your cancer shows high levels of the FGFR2b protein?
Are you able to attend regular hospital appointments for treatment and tests?
Are you not currently pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive regular medical check-ups and treatments. This includes getting the study medicines, bemarituzumab and bevacizumab, likely through an infusion (a drip into your vein). You will have frequent visits to the hospital or clinic for these treatments and to monitor your health.

During these visits, doctors will perform various tests such as blood tests, scans (like CT or MRI scans) to see how the cancer is responding, and physical examinations. This is to closely watch for any side effects and to see how well the treatment is working for you. You will also have follow-up visits after your treatment period to see how you are doing over time.

The total length of time you participate in the study will depend on how your cancer responds to the treatment and your general health. Some people may be on the study treatment for many months, while others might stop sooner if the treatment isn't working or if side effects become too difficult. The study team will explain the expected schedule in detail.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit of this study is that you might gain access to a new treatment combination that is not yet widely available. This treatment could potentially help control your cancer, or improve your quality of life. However, it's also possible that the treatment may not help your cancer, or that it could cause side effects. Like all medicines, bemarituzumab and bevacizumab can have side effects, which can range from mild to serious. The study team will carefully monitor you for these and explain them thoroughly. Remember, taking part in a study is always voluntary, and you have the right to withdraw at any time for any reason without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France

Common questions

What is gynaecological cancer?

Gynaecological cancer is a type of cancer that starts in a woman's reproductive organs, such as the ovaries, womb (uterus), or cervix.

What does 'advanced' or 'metastatic' mean?

It means the cancer has spread beyond where it first started to other parts of your body.

What is FGFR2b overexpression?

FGFR2b is a protein that can be found on cancer cells. 'Overexpression' means there's a lot more of this protein than usual on your cancer cells.

Will this study be a cure for my cancer?

This early-stage study is primarily focused on learning if the treatment is safe and effective in controlling the cancer. It is not guaranteed to be a cure.

What are Phase I and Phase II studies?

These are early stages of clinical research. Phase I checks safety, and Phase II looks at whether the treatment shows promise in treating the disease.