A Study to Test Different Doses of BI 1701963 Alone and Combined With Trametinib in Patients With Different Types of Advanced Cancer (Solid Tumours With KRAS Mutation)
This research study is for adults who have advanced cancer (solid tumours) that carries a specific change known as a KRAS mutation. This type of mutation can make cancer grow faster. Previous treatments for their cancer haven't worked well. The study is looking at a new medicine called BI 1701963, which is being given to people for the first time. It aims to stop the KRAS mutation from encouraging cancer growth. It's tested alone and sometimes with another approved cancer medicine called trametinib. Doctors want to find the safest and most effective dose of these medicines and see if they can help shrink tumours. Participants take tablets daily, and their health and tumour size are regularly checked.
At a glance
What is this study about?
This study is for adults who have advanced cancer, meaning it has spread or is difficult to treat, and previous chemotherapy hasn't been effective. Crucially, your cancer must have a specific genetic change called a KRAS mutation. This mutation is like a switch that can make cancer cells grow more quickly. Researchers are hopeful that medicines targeting this mutation could help.
The study involves a new medicine called BI 1701963, which is being carefully given to people for the very first time. Its purpose is to try and block the effects of the KRAS mutation. In some parts of the study, it's given by itself, and in other parts, it's combined with an existing approved cancer medicine called trametinib, which works in a slightly different way to slow cancer growth. The main aim is to work out the safest and best dose of BI 1701963, both alone and when given with trametinib, that people can comfortably take.
Another important goal is to see if combining these medicines can actually shrink tumours. This research is a vital step in developing new treatments for cancers with the KRAS mutation, and it helps doctors understand how these new drugs work in the human body. Your participation would provide valuable information for future patients.
Key takeaways
- Targets advanced solid cancers with a specific KRAS gene mutation.
- Tests a new drug (BI 1701963) alone or combined with an existing drug (trametinib).
- Aims to find safe doses and see if tumours shrink.
- First time BI 1701963 is given to humans.
- Participants take daily tablets and have regular health checks.
Who may be eligible?
To join this study, you must be at least 18 years old and have a type of advanced solid cancer where previous treatments haven't worked out. A key requirement is that your specific cancer must have a genetic change called a KRAS mutation. Doctors will also need to be able to measure your tumour to see if the treatment is working, and your general health needs to be good enough to take part.
There are also some important reasons why you might not be able to join. For example, if you've had certain other cancer treatments very recently, or if you've had previous treatments aimed at the same pathways that these new drugs target. People with certain serious heart conditions or very recent major surgery would also not be able to take part for their safety.
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 solid tumour that has advanced and for which previous treatments haven't worked?
- Has your cancer been tested and confirmed to have a KRAS gene mutation?
- Can doctors measure your tumour to see if the treatment is working?
- Do you have good enough general health to take part, including heart and organ function?
- Have you not had any major surgery in the last 4 weeks or certain other cancer treatments very recently?
What does participation involve?
If you decide to join this study, you will take tablets of BI 1701963 (and sometimes trametinib) once every day. You'll have regular hospital visits so doctors can closely monitor your health and how you're responding to the treatment. This will include blood tests, body scans to check your tumour size, and discussions about any side effects you might be experiencing. The study aims to find the right dose, so your dose may change over time.
You can stay in the study for as long as the treatment seems to be helping you and you are managing any side effects well. The total duration of your participation will depend on how you respond to the treatment, but you will be closely looked after throughout. You will have regular checks to record any unwanted effects and doctors will ensure your overall health is monitored.
Potential risks and benefits
Locations (8)
- Dana-Farber Cancer InstituteVerified postcodeBoston, United States
- Levine Cancer InstituteVerified postcodeCharlotte, United States
- Sarah Cannon Research Institute-Nashville-48456Verified postcodeNashville, United States
- The University of Texas MD Anderson Cancer CenterVerified postcodeHouston, United States
- Universitätsklinikum Köln (AöR)Verified postcodeCologne, Germany
- Universitätsklinikum FrankfurtVerified postcodeFrankfurt am Main, Germany
- Erasmus Medisch Centrum-ROTTERDAM-50697Verified postcodeRotterdam, Netherlands
- Universitair Medisch Centrum UtrechtVerified postcodeUtrecht, Netherlands
Common questions
What is a KRAS mutation?
A KRAS mutation is a specific change in the genetic code of your cancer cells that can make them grow and spread faster than normal.
Is BI 1701963 a new medicine?
Yes, BI 1701963 is a new medicine being tested in people for the first time in this study.
Will I get both medicines?
In some parts of the study, you might receive only BI 1701963, while in other parts, you'll receive it combined with trametinib.
How long will I be on the study treatment?
You can stay on the study treatment for as long as it is helping you and you can manage any side effects, which means the duration can vary for each person.
What kind of cancer does this study focus on?
This study focuses on advanced solid tumours that have the specific KRAS genetic mutation.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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