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

A study to find a suitable dose of BI 1821736 and test whether it helps people with advanced cancer

This research study is for people with advanced solid cancers, which are cancers that have grown or spread in the body. Doctors are testing a new medicine called BI 1821736. The main goals are to find the safest and most effective dose of this medicine and to see if it can help treat these advanced cancers. This is a very early-stage study, meaning it's the first time this medicine is being given to people. The study includes adults aged 18 and over, both men and women. If you have advanced solid cancer and are considering new treatment options, this study aims to explore a potential new way to fight the disease.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

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

Enrolment target

Start

08 Sep 2023

Advanced solid tumors

What is this study about?

This study is about a new medicine called BI 1821736 and how it might help people with advanced solid cancers. 'Advanced solid cancers' means cancers that have spread from where they started to other parts of the body, or cancers that have grown. Scientists are always trying to find new ways to treat cancer, and this study is a very important first step for this particular medicine.

The main purpose of this study is two-fold. Firstly, it aims to find the right amount, or 'dose', of BI 1821736 that can be given safely to people. This is really important because medicines need to be given at a dose that is strong enough to work but not so strong that it causes too many side effects. Secondly, the study will check if BI 1821736 actually helps to treat advanced solid cancers. This is an early-stage study, which means it's the very first time this new medicine is being tested in humans.

Taking part in a study like this helps doctors learn more about new treatments. The information gathered will help them decide if this medicine is promising enough to be tested in larger groups of people in the future. It's a key step in developing new cancer treatments.

Key takeaways

This study tests a new medicine for advanced solid cancers.
It's an early-stage study, looking for the right dose and how well it works.
Open to adults aged 18 and over, both men and women.
Participation involves regular check-ups and monitoring.
You can stop participating at any time.

Who may be eligible?

This study is looking for adults who have advanced solid cancers. 'Advanced' means the cancer has spread or grown in a way that makes it harder to treat with standard methods. Solid cancers are those that form a lump or growth, like breast cancer or lung cancer, rather than blood cancers like leukaemia.

To be considered, you must be at least 18 years old. Both men and women can take part in this study. The medical team running the study will check other specific health details to make sure the study medicine is right and safe for you. This might include recent treatments you've had, other health conditions, and blood test results.

It's important to discuss your full medical history with the study doctors. They will explain all the specific requirements and check if you meet all the criteria to join the study.

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 solid cancer (a cancer that has spread or grown)?
Are you able to attend regular hospital or clinic visits?
Are you willing to try a new, experimental cancer treatment?
Do you understand that this is an early-stage study?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would likely have regular visits to the hospital or clinic. These visits will involve various checks, such as blood tests, physical examinations, and scans to see how your cancer is responding and how you are feeling. You would be given the study medicine, BI 1821736, and the doctors would carefully monitor how your body reacts to it and if there are any side effects. The total duration of your participation would be explained by the study team, and it would involve ongoing check-ups, potentially even after you stop taking the study medicine.

Potential risks and benefits

Participating in this study might offer a chance to try a new medicine that could help treat your advanced cancer, especially if other treatments haven't worked or aren't suitable. However, because this is a new medicine, there might be unknown side effects or it might not work for everyone. The study team will carefully explain all known risks and monitor you closely for any problems. You are always free to leave the study 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
Sweden
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Unverified
Spain

Common questions

What kind of cancer is this study for?

This study is for people with 'advanced solid tumors,' which are cancers that have grown or spread, affecting organs and tissues, not blood.

What is the new medicine called?

The new medicine being tested in this study is called BI 1821736.

Is this a new treatment?

Yes, this is a very early-stage study, meaning it's the first time this medicine is being given to people.

Who can take part in the study?

Adults aged 18 and older, both men and women, with advanced solid cancers might be able to participate.

What is the main goal of the study?

The main goals are to find a suitable dose of the new medicine and see if it helps treat advanced cancers.