AuthorisedHuman Pharmacology (Phase I)- OtherInterventional

A study to learn more about how safe BAY 3771249 is and how well it works in people with advanced or metastatic colorectal cancer that has a KRAS G12D mutation

Researchers are conducting a study to learn more about a new medicine called BAY 3771249. This medicine is for people in the UK aged 18 or over who have advanced bowel cancer (adenocarcinoma of the colon or rectum) that has spread to other parts of the body. Importantly, the cancer must have a specific genetic change, which doctors call a KRAS G12D mutation. This is a very early-stage study, meaning it's one of the first times this medicine is being tested in people. The main goals are to find out if the medicine is safe to use, what side effects it might cause, and whether it shows any promise in treating this type of cancer. It's a vital step in developing new treatments for advanced bowel cancer.

At a glance

Status

Authorised

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Bayer Consumer Care AG

Enrolment target

Start

08 Jun 2026

adenocarcinoma of the colon or rectum

What is this study about?

This research study is about finding new ways to treat advanced bowel cancer (also known as colorectal cancer). When cancer is advanced, it means it has grown or spread to other parts of the body. Doctors are particularly interested in a specific type of bowel cancer that has a genetic change called a KRAS G12D mutation. This mutation makes the cancer behave in a particular way, and traditional treatments might not work as well.

The study is investigating a new medicine, or 'drug', named BAY 3771249. Because this is a very early-stage study (often called a Phase I study), the main things the researchers want to learn are whether this new medicine is safe for people to take and what dose is best. They will also be looking to see if the medicine has any positive effects on the cancer itself, such as stopping it from growing or shrinking it.

Learning about these things is crucial. It helps scientists decide if the medicine has enough potential to be tested in larger studies with more people. If successful, this new medicine could eventually offer another treatment option for people with this specific type of advanced bowel cancer.

Key takeaways

This study is testing a new medicine (BAY 3771249) for advanced bowel cancer.
It's specifically for bowel cancer with a genetic change called a KRAS G12D mutation.
Researchers want to find out if the medicine is safe and if it helps treat the cancer.
It's an early-stage study, so the medicine is new and its full effects are not yet known.
Participation involves regular hospital visits, tests, and taking the study medicine.
You can stop taking part at any time without affecting your normal healthcare.

Who may be eligible?

To be part of this study, you need to meet certain requirements. The most important one is that you must have a type of bowel cancer (adenocarcinoma of the colon or rectum) that has spread to other parts of your body, meaning it's considered advanced or metastatic. Your cancer also needs to have a specific genetic change called a KRAS G12D mutation. Doctors can test for this mutation.

You must be at least 18 years old to join, and there is no upper age limit. Both men and women can take part in this study. There will be other specific health checks and tests that the study doctors will need to carry out to make sure the treatment is safe for you.

It's important to understand that not everyone with advanced bowel cancer will be able to join. The study team needs to make sure that the people who take part are the right fit for this specific research, both for their safety and for the study to get clear results.

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.

I am 18 years old or older.
I have been diagnosed with advanced bowel cancer (colon or rectum).
My cancer has a specific genetic change called a KRAS G12D mutation (my doctor can test for this).
I am willing and able to attend regular hospital visits and undergo tests.
I am able to understand the study and what is involved.

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first have a number of tests. These tests are to ensure that the study medicine is safe for you and that you meet all the necessary requirements. These might include blood tests, scans (like CT scans or MRI scans), and checking your cancer's genetic features.

If you are found to be suitable, you would then start taking the study medicine, BAY 3771249. The study team would closely monitor you, which means you would have regular visits to the hospital or clinic. During these visits, you'd have more blood tests, physical examinations, and scans to see how you are doing and how the medicine is affecting your cancer. These visits would help the doctors understand the medicine's safety and how well it is working.

The total length of time you would be involved in the study can vary. You would likely continue receiving the treatment and having follow-up appointments for as long as the medicine is helping you and you are not experiencing severe side effects. After you stop taking the medicine, there would still be some follow-up visits to check on your health and any long-term effects.

Potential risks and benefits

Taking part in an early-stage study like this means there are potential benefits and potential risks. The main potential benefit is that the new medicine, BAY 3771249, might help to treat your cancer when other treatments haven't worked or are no longer suitable for you. This could potentially slow down the cancer's growth or even shrink it. However, because this is a new medicine, not all its side effects are known. You might experience side effects, some of which could be unpleasant or serious. The study team will monitor you very closely and tell you about all known risks. Remember, your participation is completely voluntary, and you can change your mind and withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (5)

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

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Unverified
Finland
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Unverified
Sweden
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Unverified
Italy
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Unverified
Denmark
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Unverified
Netherlands

Common questions

What does 'advanced or metastatic colorectal cancer' mean?

It means the bowel cancer has grown beyond its original site and spread to other parts of the body.

What is a 'KRAS G12D mutation'?

It's a specific change in the genes of the cancer cells. Doctors can test your tumour to see if it has this change.

Is this medicine available to everyone with bowel cancer?

No, this is a new medicine being tested in a study. It's only for people who fit very specific criteria, including having the KRAS G12D mutation.

Will I receive the new medicine or a dummy treatment (placebo)?

This is an early-stage study to find out about the medicine's safety and effects. In such studies, participants usually receive the new medicine, not a dummy treatment.

How long will the study last?

The time you spend in the study can vary. You would typically continue treatment and monitoring as long as the medicine is helping and without severe side effects, with follow-up appointments afterwards.