Ongoing, recruitingHuman Pharmacology (Phase I)- First administration to humansInterventional

First-in-man clinical trial to assess safety and tolerability of CEB-01 PLGA membrane in patients with recurrent or locally advanced retroperitoneal soft tissue sarcoma after surgery

This study is testing a new treatment called CEB-01 PLGA membrane for a type of cancer known as retroperitoneal soft tissue sarcoma. This is a rare cancer that affects soft tissues deep inside the body, and this study is specifically for patients where the cancer has returned or spread nearby after they’ve had surgery. Because this is the very first time this treatment is being given to people, the main goal is to find out if it's safe to use and how well patients' bodies cope with it. It's an early-stage study, meaning researchers are taking the first steps to understand this new approach before looking at whether it can cure the cancer.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Cebiotex S.L.

Enrolment target

Start

20 Aug 2024

Recurrent or locally advanced retroperitoneal soft tissue sarcoma

What is this study about?

This study is an important first step in testing a new treatment for a type of cancer called retroperitoneal soft tissue sarcoma. This cancer affects soft tissues – like fat, muscle, or blood vessels – deep inside your tummy area (retroperitoneal means behind the lining of your abdomen). It's a complicated cancer, and sometimes even after surgery to remove it, it can come back or grow nearby.

The new treatment being tested is a special patch or film, called CEB-01 PLGA membrane. Doctors are trying to see if placing this membrane in the body could help patients. Because this is the very first time this membrane is being given to humans, the main goal is to check its safety and see how well people's bodies tolerate it. This helps doctors learn the best way to use it and if it’s safe enough to study further.

Finding new ways to treat this type of soft tissue sarcoma is really important for patients. Even though this study is focused on safety, it's a crucial part of developing potential future treatments that could make a real difference. If this membrane proves to be safe, it could lead to more studies to see if it can help stop the cancer from coming back or spreading.

Key takeaways

This study is testing a new membrane treatment (CEB-01 PLGA) for retroperitoneal soft tissue sarcoma.
It's for patients whose cancer has returned or spread nearby after previous surgery.
The main aim is to assess the safety and how well people tolerate this new treatment.
This is a 'first-in-human' study, meaning it's the first time people are receiving this specific treatment.
It’s an early-stage study to gather important safety information for future research.

Who may be eligible?

This study is for adults aged 18 and over. Both men and women can take part. To be suitable, you would need to have been diagnosed with retroperitoneal soft tissue sarcoma that has either come back or grown locally after you've already had an operation to remove it.

There might be other specific health requirements or conditions that mean you can or cannot join the study. These are put in place to ensure your safety and that the study results are clear.

It's very important to talk to your doctor or the study team to find out if this study is right for you. They can review your full medical history and explain all the detailed requirements.

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?
Have you been diagnosed with retroperitoneal soft tissue sarcoma?
Has your cancer come back or spread locally after previous surgery?
Are you able to attend regular hospital appointments and follow-up checks?
Are you willing to discuss your full medical history with the study team?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first have a number of checks to make sure you are suitable. Once enrolled, you would receive the CEB-01 PLGA membrane, likely during surgery. After this, you would have regular appointments at the hospital. These appointments are important for the medical team to monitor your health, check for any side effects from the treatment, and see how your body is responding.

These visits might include physical examinations, blood tests, and scans. The study team will explain exactly how many visits you would need, what each visit involves, and for how long you would be followed up. You would have a clear schedule, and all your questions would be answered before you start.

Potential risks and benefits

Taking part in any medical study carries potential benefits and risks. For this study, a potential benefit is receiving a brand new treatment approach that might help manage your cancer, although the main goal at this early stage is to assess safety, not to cure the disease. However, there are also potential risks, including side effects from the new membrane or from the procedures involved. The doctors and nurses will carefully monitor you for any problems. You will be fully informed about all known risks before you decide to join, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual 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
Spain

Common questions

What is retroperitoneal soft tissue sarcoma?

It's a rare cancer that develops in the soft tissues (like muscle, fat, or blood vessels) located deep inside your abdomen, behind where most of your tummy organs are.

What is the CEB-01 PLGA membrane?

It's a new type of special patch or film that doctors are testing as a treatment. In this very first study, they want to find out if it is safe for people to use.

What does 'first-in-man' mean?

It means this is the very first time this treatment is being given to humans. It's an early safety check before it can be studied further to see if it treats cancer.

Will this treatment cure my cancer?

The main goal of this very early study is to check if the new treatment is safe and tolerable. It's not designed to look at whether it can cure the cancer at this stage.

Can I leave the study if I change my mind?

Yes, absolutely. You can decide to leave the study at any point, for any reason. Your medical care will not be affected if you choose to stop participating.