Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A study to determine how BI 907828 (Brigimadlin) is taken up in the tumor (Phase 0) and to determine the highest dose of BI 907828 (Brigimadlin) that could be tolerated (Phase Ia) in combination with radiation therapy in people with a brain tumor called glioblastoma

This research is testing a new medicine called Brigimadlin (also known as BI 907828) for adults with a type of brain tumour called glioblastoma. The study has two main goals. First, it wants to understand how the drug gets into the tumour. Second, it aims to find the highest amount of Brigimadlin that people can safely take when it's combined with radiotherapy, which is a common treatment for brain tumours. This is an early phase of testing (Phase 0 and Phase 1a), meaning it's one of the first times this drug is being studied in people. The information gathered will help doctors decide if and how to use this drug in future larger studies to help patients with glioblastoma.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A.

Enrolment target

Start

06 Nov 2023

Glioblastoma

What is this study about?

This study is dedicated to understanding a new medicine called Brigimadlin (also known by its code BI 907828) for adults living with glioblastoma. Glioblastoma is a serious type of brain tumour, and researchers are always looking for new ways to treat it effectively. This particular study is in its very early stages, sometimes called Phase 0 and Phase 1a, which means it’s one of the first times this drug is being tested in people. This early testing is crucial because it helps scientists gather fundamental information before the drug can be studied more widely.

The main purpose of the study is twofold. Firstly, it wants to see how Brigimadlin behaves once it's in the body, specifically how it reaches and is taken up by the tumour. This is important to ensure the drug targets the right place. Secondly, the study aims to identify the highest possible dose of Brigimadlin that people can tolerate without experiencing too many side effects when it's given alongside radiotherapy. Radiotherapy is a standard treatment for glioblastoma, so understanding how the new drug works with it is key.

By carefully finding the right dose and understanding how the drug works inside the body, this research will provide vital information. This knowledge will help doctors and researchers design future, larger studies to see if Brigimadlin can improve treatment for people with glioblastoma. It’s a step towards potentially developing new treatment options for this challenging condition.

Key takeaways

This study is testing a new drug, Brigimadlin, for glioblastoma.
It aims to understand how the drug works in the tumour.
The study will find the safest dose when given with radiotherapy.
It's an early-stage study (Phase 0 and 1a) for adults with glioblastoma.
Involves regular hospital visits for monitoring and tests.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

This study is looking for adults who are at least 18 years old. People of any age above 18 can take part. Both men and women are welcome to participate.

Because this is a study for people with a specific type of brain tumour, you would need to have been diagnosed with glioblastoma. There will be other health requirements and tests to make sure the study is a good fit for you and safe for your health. For example, your doctors will check your general health, organ function, and any other medications you are taking.

It’s important to talk to your own doctor or the study team to find out all the details about who can and cannot join. They will be able to tell you if your specific health situation matches what the study needs.

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 glioblastoma (a specific type of brain tumour)?
Are you available for regular hospital visits and medical tests?
Are you able to take study medication and receive radiotherapy?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the new drug, Brigimadlin, in combination with radiotherapy. You would have regular visits to the hospital or clinic to monitor your health closely. These visits would involve various tests such as blood tests, scans (like MRI scans of your brain), and physical examinations. These tests help the doctors understand how your body is reacting to the drug and how the drug is affecting your tumour.

The study would start with a period where the doctors find the right dose for you, often with increasing doses until a safe level is found. After this initial period, you would continue with the treatment and monitoring for a set time. There would also be follow-up visits after you finish the treatment to ensure your well-being. The exact number of visits, tests, and the total duration in the study would be explained in detail by the study team, as it can vary for each person. Throughout your participation, you would be fully supported by the medical team.

Potential risks and benefits

Participating in an early-stage study like this means you would be among the first to try a new medicine, which could potentially offer a new treatment option for glioblastoma. However, because it's a new drug, all its potential side effects might not be fully known, and there's no guarantee it will benefit your condition. The study team will closely monitor you for any side effects, which might range from mild to more serious. You will be fully informed about all known risks before you decide to join. Remember, taking part in any study is entirely your choice, and you are free to withdraw at any time, for any reason, without it affecting your usual medical care.

Locations (2)

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

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Unverified
Belgium
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Unverified
Spain

Common questions

What is glioblastoma?

Glioblastoma is a serious and aggressive type of brain tumour that grows quickly. Researchers are always looking for new treatments for it.

What is Brigimadlin?

Brigimadlin is the name of a new medicine, also known as BI 907828, that is being tested in this study to see if it can help treat glioblastoma.

What does 'Phase 0 and Phase 1a' mean for a study?

These are very early stages of testing a new drug in people. Phase 0 looks at how the drug works, and Phase 1a focuses on finding a safe dose and side effects.

Will I receive radiotherapy in this study?

Yes, Brigimadlin is being tested in combination with radiotherapy, which is a common treatment for glioblastoma.

Can I stop participating in the study at any time?

Yes, you have the right to withdraw from the study at any point, and your decision will not affect your future medical care.