Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

This study aims to find the best dose of BI 907828 (brigimadlin) in patients with different types of advanced cancer (solid tumors)

This research study is trying to find the most effective and safest dose of a new drug named BI 907828, also known as brigimadlin. It's for adults who have advanced solid cancers, meaning cancers that have either grown significantly or spread to other parts of the body. This is a very early stage (Phase I) study, which means researchers are primarily focused on understanding how the drug acts in the human body, including how it's absorbed, processed, and leaves the body, and what dose levels are safe. This information is crucial for developing the drug further and potentially helping people with these challenging cancers in the future.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

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

Enrolment target

112

Start

26 Sep 2024

Advanced or metastatic solid tumors

What is this study about?

This study is trying to find the best dose of a new medicine, which has the code BI 907828 and is also called brigimadlin. This medicine is designed for people who have advanced solid tumors. Solid tumors are types of cancer that form a lump, like breast cancer or lung cancer, as opposed to blood cancers like leukaemia. 'Advanced' means the cancer has either grown quite a lot or has spread to other parts of your body.

The main goal of this study is to figure out the right amount of this new medicine to give. This is important because giving too little might not help, and giving too much could cause side effects. By finding the 'best dose,' doctors can then study the medicine further to see if it can be an effective treatment.

This is a very early-stage study, often called a 'Phase I' study. In this type of study, researchers are mainly focused on understanding how the new medicine behaves in the human body. They want to see how your body takes in the medicine, how it breaks it down, and how it gets rid of it. They are also looking closely for any side effects and trying to find a safe dose range before moving on to larger studies to test how well it treats cancer.

Key takeaways

This study is testing a new cancer medicine called BI 907828 (brigimadlin).
It's for adults aged 18 and over with advanced solid tumors.
The main aim is to find the best and safest dose of the medicine.
It's an early-stage study, focusing on how the drug acts in the body.
There's a chance to try a new drug, but also potential risks and unknown side effects.

Who may be eligible?

This study is for adults, meaning you must be at least 18 years old to take part. There is no upper age limit, so older adults could also be considered.

To be in the study, you must have a type of advanced cancer that is a 'solid tumor.' This means cancers that form a mass or lump, rather than blood cancers. Your cancer needs to be advanced, which means it has grown or spread to other parts of your body. Doctors will check your medical records and do some tests to make sure your specific type and stage of cancer match what they are looking for.

There might be other health checks or specific requirements your doctor will discuss with you to ensure it's safe for you to take part and that the study results will be clear. For example, they might look at your general health, other medical conditions you have, or any medicines you are currently taking.

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 an advanced type of solid tumor cancer?
Have your doctors confirmed your cancer type fits the study criteria?
Are you generally well enough to take part in a clinical study?
Are you able to attend regular appointments and tests?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will have regular visits to the hospital or clinic. These visits will likely involve several tests, such as blood tests, urine tests, and possibly scans, to check your general health and see how the study medicine is affecting your body and the cancer. You will receive the study medicine, BI 907828 (brigimadlin), according to a specific schedule decided by the researchers. This medicine might be given as tablets or through a drip, depending on what the study specifies. You'll be closely monitored for any side effects throughout the study, and you will have follow-up visits even after you stop taking the medicine to make sure you are well. The total time you might spend in the study will vary depending on how you respond to the treatment and the study plan, but early-stage studies often involve several months of active treatment and follow-up.

Potential risks and benefits

Taking part in a study like this might offer a potential benefit of being among the first to try a new medicine that could help with your advanced cancer, although it's important to remember that this is an early-stage study and its main purpose is to understand the drug, not primarily to treat disease. There are potential risks, as with any new medicine, including unknown side effects or the medicine not working as hoped. Your doctors will carefully monitor you for any problems. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (6)

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

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Unverified
Spain
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Unverified
Belgium
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Unverified
Sweden
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Unverified
Germany
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Unverified
Denmark
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Unverified
Poland

Common questions

What is a 'solid tumor'?

A solid tumor is a type of cancer that forms a lump or mass, like breast cancer or lung cancer. It's different from blood cancers.

What does 'advanced cancer' mean?

Advanced cancer means the cancer has grown significantly or has spread from where it started to other parts of your body.

What is a 'Phase I' study?

A Phase I study is an early-stage study that mainly aims to find a safe dose for a new medicine and see how it works in the human body.

Will this medicine cure my cancer?

It's too early to say if this medicine will cure cancer. This study's main goal is to find a safe dose and understand the drug better.

Can I stop being in the study if I change my mind?

Yes, you can choose to leave the study at any time, and it won't affect the care you receive from your doctors.