RecruitingPHASE1INTERVENTIONAL

A First-in-human Study to Learn About the Safety of BAY 3547926 and How Well it Works in Participants With Advanced Liver Cancer

This research is a first-time study in humans, focusing on a new drug called BAY 3547926 for advanced liver cancer (specifically, hepatocellular carcinoma or HCC) that has a special protein called Glypican 3 (GPC3). Scientists want to understand if the drug is safe, how effective it is, and what the best dose might be. BAY 3547926 works by delivering a small amount of radiation directly to the cancer cells to harm them, with the aim of causing little damage to healthy tissues nearby. Participants will be in different parts of the study, starting with finding a safe and effective dose, then moving to larger groups to test the drug alone or with other treatments. This study is crucial for learning more about this potential new liver cancer treatment.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

Bayer

Enrolment target

148

Start

28 Feb 2025

Estimated completion

31 Aug 2031

Hepatocellular Carcinoma

What is this study about?

This study is looking into a brand-new medicine called BAY 3547926. It's designed for people who have advanced liver cancer, specifically a type known as hepatocellular carcinoma (HCC). The cancer must also have a particular protein called Glypican 3 (GPC3) for this medicine to work.

The main goals of this research are to find out if BAY 3547926 is safe for people to take, and how well it works against this type of liver cancer. Researchers also want to find the right amount, or 'dose', of the medicine that is both effective and safe. They'll also be watching how your body uses and gets rid of the drug, which helps them understand it better.

Here's how BAY 3547926 works: it's designed to carry a tiny amount of radiation directly to the cancer cells. This radiation then damages those cells, hopefully causing them to die. The good news is that this radiation is expected to travel only a very short distance. This means it's hoped that it will mainly affect the cancer cells, causing much less harm to the healthy parts of your body around them. This is the very first time this specific medicine is being tested in people.

Key takeaways

It's a first-time human study for a new liver cancer medicine.
The medicine targets specific liver cancer cells (HPC with GPC3 protein).
It uses a small amount of radiation to damage cancer cells.
Researchers want to find the safest and most effective dose.
Regular health checks and scans will be part of the study.

Who may be eligible?

To join this study, you would need to have advanced liver cancer (hepatocellular carcinoma) that has been confirmed by tests. Your cancer should also have a special protein called GPC3. This study is for people whose cancer can't be fully removed with surgery or who have tried standard treatments that haven't worked.

You also need to be generally well enough to take part. This is often described using a scale where 0 means you can do all your normal activities, and 1 means you can do most things but might have some light activity limitations. Doctors will also check that your body organs and blood are working properly, and that your cancer can be measured on scans.

There are also some reasons why you might not be able to join. For example, if you have certain rare types of liver cancer, or a history of specific brain problems, or severe fluid build-up in your tummy. Your doctor will carefully review all your medical information to see if this study could be right for you.

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.

Do I have advanced liver cancer called hepatocellular carcinoma (HCC)?
Does my cancer have a special protein called GPC3?
Has my doctor confirmed that my cancer cannot be removed by surgery or has progressed on other treatments?
Am I generally well enough to do most daily activities?
Do my blood tests and organ function appear normal enough for the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be assigned to one of four different groups. Initially, in 'Part 1', a small number of people will receive different amounts of BAY 3547926 to help doctors find the safest and most effective dose. Once that dose is found, more people will receive it either alone in 'Part 2' or alongside other treatments in 'Parts 3 and 4'.

Throughout the study, you'll have regular health check-ups. These will include having body scans (like CT or MRI) to see how the treatment is working, giving blood and urine samples, and talking with the study team. They will ask you how you're feeling and if you're experiencing any health issues or side effects. This helps the doctors monitor your safety and the drug's effects. The total duration of your participation will depend on the study design and your individual response to the treatment, which your doctor will explain fully.

Potential risks and benefits

Taking part in a study like this could offer potential benefits, as you would be among the first to receive a new treatment that might help with your liver cancer, especially if other treatments haven't been successful. However, there are also risks. Since this is a new drug, not all side effects are fully known and the treatment may not work for everyone. The study medicine involves radiation, which while targeted, could still have effects on your body. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (13)

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

Edegem
Verified postcode
Edegem, Belgium· Recruiting
Kortrijk
Verified postcode
Kortrijk, Belgium· Recruiting
Leuven
Verified postcode
Leuven, Belgium· Recruiting
Toronto
Verified postcode
Toronto, Canada· Recruiting
Montréal
Verified postcode
Montreal, Canada· Recruiting
Montreal
Verified postcode
Montreal, Canada· Recruiting
Sherbrooke
Verified postcode
Sherbrooke, Canada· Recruiting
Tampere
Verified postcode
Tampere, Finland· Recruiting
Turku
Verified postcode
Turku, Finland· Recruiting
Madrid
Verified postcode
Madrid, Spain· Recruiting
London
Verified postcode
London, United Kingdom· Recruiting
Glasgow
Verified postcode
Glasgow, United Kingdom· Recruiting

Common questions

What kind of liver cancer is this study for?

This study is for a type of advanced liver cancer called hepatocellular carcinoma (HCC) that has a protein called Glypican 3 (GPC3).

What does BAY 3547926 do?

It's a new medicine that delivers a tiny amount of radiation directly to the cancer cells to damage them, trying to avoid harming healthy tissue.

What is 'advanced' liver cancer?

This usually means the cancer has grown or spread, or it can't be completely removed by surgery.

Will I definitely get the new drug?

Yes, all participants in this study will receive the new drug BAY 3547926, either on its own or with other treatments. It's not a study where some people get a placebo.

How long would I be in the study?

The length of time you'd be in the study depends on which part you're in and how you respond to the treatment. Your doctor can give you more details.

How to find out more

Bayer Clinical Trials Contact

clinical-trials-contact@bayer.com (+)1-888-84 22937 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.