AuthorisedPhase I and Phase II (Integrated)- OtherInterventional

A PHASE IB/II STUDY TO EVALUATE SAFETY AND EFFICACY OF BEXMARILIMAB IN COMBINATION WITH DOXORUBICIN IN METASTATIC SOFT-TISSUE SARCOMA (BEXAR Study)

This study, called BEXAR, is looking into a new treatment approach for advanced soft tissue sarcoma, a type of cancer that affects soft tissues like muscle or fat. The main goal is to test a new drug called bexmarilimab in combination with a commonly used chemotherapy called doxorubicin. Researchers want to find the safest and most effective dose of bexmarilimab when given with doxorubicin. They will also be measuring how well this combination treatment works to stop the cancer from growing or spreading. This study is for adult patients whose cancer has spread (metastatic) and for whom a cure is not currently possible with existing treatments.

At a glance

Status

Authorised

Phase

Phase I and Phase II (Integrated)- Other

Sponsor

Medica Scientia Innovation Research S.L.

Enrolment target

278

Start

08 Jun 2026

Advanced or metastatic histologically confirmed soft tissue sarcoma (STS) in adult patients who are not candidates for curative treatment.

What is this study about?

This research study, called BEXAR, is for adults who have a type of cancer called soft tissue sarcoma that has spread to other parts of the body (this is called metastatic cancer). It's for patients who are not able to be completely cured with the treatments currently available. The study is particularly interested in how two treatments work together: a new drug called bexmarilimab and a standard chemotherapy drug called doxorubicin.

The study has two main parts. The first part, called Phase Ib, is about finding the right dose. Researchers will give different doses of bexmarilimab alongside doxorubicin to a small number of patients. They will carefully watch for any side effects or problems to figure out the safest and most effective dose to use. Once they find this best dose, they move to the second part, Phase II, which aims to see how well this drug combination works.

In Phase II, the main goal is to measure how long patients live without their cancer getting worse, which doctors call 'progression-free survival' (PFS). The researchers will track how long it takes for the cancer to grow or spread, or if the patient passes away, whichever happens first. They will also look at other things, like whether the tumours shrink and for how long. This helps them understand whether bexmarilimab, when combined with doxorubicin, can be an effective new treatment option.

Key takeaways

This study combines a new drug (bexmarilimab) with a standard chemotherapy (doxorubicin) for advanced soft tissue sarcoma.
The initial aim is to find a safe and effective dose of the new drug combination.
The study will then measure how well this combination controls cancer growth and spread.
It's for adult patients whose cancer has spread and can't be cured with current treatments.
Participation involves regular hospital visits for treatment, tests, and follow-up.
Potential benefits include slowing cancer, but there are also risks of side effects.

Who may be eligible?

To join this study, you need to be an adult, 18 years or older, with a diagnosis of soft tissue sarcoma that has been confirmed by a doctor. Your cancer must have spread to other parts of your body (advanced or metastatic), and your doctors must have decided that a full cure is not possible with current treatments. Both men and women can take part in this study.

There will be other specific health requirements that the study doctors will check to make sure the treatment is safe for you. These might include how well your kidneys and liver are working, and other blood test results. You'll need to discuss all your medical history and current health conditions with the study team to see if this study is suitable 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 a diagnosis of soft tissue sarcoma?
Has your cancer spread to other parts of your body (metastatic)?
Have your doctors said that a cure is not possible with current treatments?
Are you able to travel to a study site for regular appointments?
Do you understand that this is a research study and not a guaranteed treatment?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will receive two medications: bexmarilimab and doxorubicin, as decided by the study doctors. You will have regular hospital visits for treatment, blood tests, and scans to check how you are doing and how the treatment is affecting your cancer. These tests help the doctors monitor your health and see if the treatment is working or causing any side effects. The study will continue for a period, during which you'll have these regular assessments. After the main treatment period, there will likely be follow-up visits or phone calls to keep track of your health long-term.

Potential risks and benefits

This study is testing new combinations of treatments, so there may be benefits if the treatment helps slow down your cancer or shrinks your tumours. However, there are also potential risks of side effects from the medications, some of which could be serious. The study team will explain all known side effects. You have the right to withdraw from the study 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
Spain

Common questions

What is 'soft tissue sarcoma'?

Soft tissue sarcoma is a rare type of cancer that begins in the body's soft tissues, like muscles, fat, blood vessels, or nerves.

What does 'metastatic' mean?

Metastatic means the cancer has spread from where it started to other parts of the body.

What is the new drug, bexmarilimab, supposed to do?

Bexmarilimab is being tested to see if it can help fight the cancer, possibly by working with your body's immune system or other mechanisms, when given with doxorubicin.

What is doxorubicin?

Doxorubicin is a standard chemotherapy drug often used to treat various cancers, including some types of sarcoma.

What is the difference between Phase Ib and Phase II?

Phase Ib mainly focuses on finding the safest and most effective dose of the new treatment. Phase II then uses that dose to see how well it works against the cancer in more patients.