Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A study to test different doses of BI 1823911 alone and combined with other medicines in people with different types of advanced cancer with KRAS mutation.

This medical study is looking for adults with advanced solid cancers that have a particular genetic change, known as a KRAS G12C mutation. Researchers are testing a new medicine called BI 1823911, both by itself and alongside other existing treatments. The main goal is to find the safest and most effective dose for these new medicines. This is an early-stage study, meaning it's one of the first times these specific treatments are being tested in people. It aims to understand how the body handles the medicine and if it shows signs of helping to fight the cancer. Participants will be closely monitored by a medical team.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Boehringer Ingelheim International GmbH

Enrolment target

Start

25 Jun 2024

solid tumour harbouring G12C mutation

What is this study about?

This study is for adults who have a type of advanced solid cancer where the cancer cells have a specific change in their genes called a 'KRAS G12C mutation'. This particular mutation can make cancers harder to treat, so researchers are always looking for new ways to fight them.

The study is testing a new medicine, or 'drug', called BI 1823911. They want to see how different amounts, or 'doses', of this medicine work in people. They'll also be trying it with other medicines you might already know about, to see if combining them is more effective. This is an early-stage study, which means it's one of the first times this new medicine is being given to people. The main aim is to find a dose that is both safe and has the best chance of working.

Learning how these new medicines work in the body and if they can help people with this specific type of cancer is very important. Studies like this help doctors understand new treatments better and, in the future, might offer more options for people with advanced cancers that have the KRAS G12C mutation.

Key takeaways

This study is for adults with advanced solid cancers that have a specific KRAS G12C genetic change.
It's testing a new medicine called BI 1823911, both alone and with other treatments.
The main goal is to find the safest and most effective dose of the new medicine.
Participants will receive close medical monitoring and treatment.
It's an early-stage study, meaning it's one of the first times this treatment is being tested in people.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To join this study, you need to be an adult, 18 years old or older. The study is open to both men and women.

Crucially, you must have an advanced solid cancer that has a specific genetic change called a KRAS G12C mutation. This means your cancer cells have a particular alteration that the study medicine is designed to target.

As this is early research, there will be careful checks on your overall health to make sure it's safe for you to take part. Your study doctor can tell you more about all the specific 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?
Do you have a diagnosis of advanced solid cancer?
Has your cancer been tested and found to have a KRAS G12C mutation?
Are you able to attend regular hospital appointments and tests?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll have regular hospital visits for check-ups, blood tests, and scans to see how you're responding to the treatment. You'll receive the study medicine, BI 1823911, which might be given alone or with other cancer medicines. The medical team will monitor you closely, especially in the beginning, to see how you react to the new treatment and to find the best dose. You may need to take the study medicine for some time, and there will be follow-up appointments even after you stop taking the medicine, to keep track of your health. The total duration of your participation will be explained by the study team.

Potential risks and benefits

Taking part in a clinical trial has potential benefits, such as gaining access to a new medicine that isn't yet widely available and receiving close medical supervision. However, there are also potential risks. New medicines can have side effects, which can range from mild to serious, and there's no guarantee the treatment will work for you. The study team will explain all known risks and closely monitor you for any side effects. Remember, you have the right to withdraw from 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
Spain
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Unverified
Belgium

Common questions

What is a 'KRAS G12C mutation'?

It's a specific change in the genes of your cancer cells. This change is important because the new medicine in this study is designed to target it directly.

What does 'advanced solid cancer' mean?

It means a cancer that has spread from where it started to other parts of the body, and it's not a blood cancer like leukaemia.

What is a 'Phase I' study?

This is an early stage of research where doctors are mainly looking at the safety of a new medicine in people and trying to find the best dose, rather than how well it works.

Will I know if I'm getting the new medicine or a different one?

The study team will explain exactly which medicines you will receive. This study is testing specific doses of BI 1823911, sometimes with other cancer medicines.

Will I have to pay to be part of the study?

No, you will not have to pay for the study medicine or for the study-related tests and appointments. Travel costs may sometimes be reimbursed, but you should check this with the study team.