Active not recruitingPHASE1INTERVENTIONAL

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 study is for adults with advanced or spreading cancer, such as lung, bowel, or pancreatic cancer, if earlier treatments haven't worked or there are no other options. You can join if your tumour has a specific genetic change called a KRAS mutation, which can make cancer grow faster. Researchers are testing two new medicines, BI 1823911 and BI 1701963, which aim to target this KRAS mutation. BI 1823911 is being given to people for the first time. The study will find the right dose of these medicines and see if they can shrink tumours. Participants take tablets daily and are closely monitored by doctors for benefits and any unwanted effects.

At a glance

Status

Active not recruiting

Phase

PHASE1

Sponsor

Boehringer Ingelheim

Enrolment target

Start

09 Sep 2021

Estimated completion

27 Dec 2026

Solid Tumors, KRAS Mutation

What is this study about?

This study is looking for new ways to treat advanced cancer that has spread to other parts of the body. Cancers like lung, bowel, pancreas, and bile duct cancer are included. It's designed for people whose previous treatments haven't worked or for whom there aren't any other suitable treatment options.

The study focuses on cancers that have a specific change in their genes called a KRAS mutation. This mutation can make cancer grow more quickly. The researchers are testing two new medicines, BI 1823911 and BI 1701963, which are designed to target and stop this KRAS mutation from making cancer cells grow. BI 1823911 is a completely new medicine being tested in humans for the very first time.

The main goals are to find a safe and effective dose of BI 1823911, both on its own and when given with BI 1701963. Once the best dose is found, the researchers will then check if these medicines can help shrink tumours. Participants can continue taking part in the study as long as the treatment is helping them and they are not experiencing too many side effects.

Key takeaways

Tests new medicines for advanced cancers with a specific KRAS mutation.
For adults whose previous treatments were not successful or have no options.
Aims to find the best dose and see if tumours shrink.
Involves daily tablets and regular doctor check-ups.
BI 1823911 is a new medicine being tested for the first time in people.

Who may be eligible?

To join this study, you must be an adult aged 18 or over with a type of advanced cancer that has spread, such as lung cancer (of a specific type), bowel cancer, pancreatic cancer, or bile duct cancer. Your cancer must have been confirmed by tests, and it's important that your previous treatments haven't been successful, or that there are no standard treatments currently available for your specific cancer.

A key requirement is that your tumour has a specific genetic change called a KRAS G12C mutation. This means your cancer cells have a particular fault that the new medicines aim to target. You also need to be generally well enough to take part, meaning you can carry out most of your daily activities without much help, and your important organs like your liver, kidneys, and blood are working well enough.

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 an adult aged 18 or older?
Do you have advanced lung, bowel, pancreatic, or bile duct cancer?
Has your cancer progressed despite previous treatments, or are there no standard treatments available?
Has your cancer been tested and confirmed to have a KRAS G12C mutation?
Are you generally well and able to perform most daily activities?
Do your blood tests show your organs (like liver and kidneys) are working well enough?

Answer every question to see your result.

What does participation involve?

If you join the study, you will take tablets of BI 1823911, either by itself or along with BI 1701963, once a day. You'll need to visit the study doctor regularly so they can monitor your progress. During these visits, doctors will keep a close eye on the size of your tumours through scans and check-ups. They will also regularly assess your general health and record any new symptoms or side effects you might experience.

More detailed checks will happen throughout the study, including blood tests to make sure your organs are working properly and to look for specific markers related to your cancer and the treatment. You can stay in the study for as long as the treatment is helping you and you feel well enough to continue.

Potential risks and benefits

Taking part in this study may offer the potential benefit of accessing new medicines that could help shrink or control your cancer, especially if other treatments haven't worked. However, these are new medicines, and there's a chance they might not help everyone or could cause side effects, some of which may be serious. The study team will carefully monitor your health throughout to manage any side effects. You are free to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (9)

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

Memorial Sloan-Kettering Cancer Center
Verified postcode
New York, United States
Sarah Cannon Research Institute at Mary Crowley
Verified postcode
Dallas, United States
The University of Texas MD Anderson Cancer Center
Verified postcode
Houston, United States
Brussels - HOSP Jules Bordet
Unverified
Anderlecht/Brussels-Capital, Belgium
Edegem - UNIV UZ Antwerpen
Unverified
Edegem/Antwerpen, Belgium
Universitair Ziekenhuis Gent
Unverified
Gent/Oost-Vlaanderen, Belgium
UZ Leuven
Unverified
Leuven/Vlaams-Brabant, Belgium
Hospital Universitari Vall D Hebron
Verified postcode
Barcelona, Spain
The Christie
Verified postcode
Manchester, United Kingdom

Common questions

What is a KRAS mutation?

It's a specific change in the genes of your cancer cells that can make them grow faster. The new medicines in this study aim to target this change.

What does 'advanced cancer' mean?

It means the cancer has grown or spread beyond where it started, and earlier treatments haven't been successful or there are no standard treatment options left.

Will I get both medicines?

You might take BI 1823911 alone or in combination with BI 1701963, depending on the part of the study you are in. Your doctor will explain this.

How long will I be in the study?

You can stay in the study for as long as the treatment is helping you and you are able to tolerate it well, without severe side effects.

Are these medicines approved for general use?

No, these are new medicines being tested in a clinical trial. They are not yet approved for general use outside of research studies.