Ongoing, recruitingHuman Pharmacology (Phase I)- First administration to humansInterventional

A first-in-human study to learn how safe the study treatment BAY2862789 is, to find the best dose, how it affects the body, what maximum amount can be given, how it moves into, through and out of the body, and how it acts on different tumors in participants with advanced solid tumors

This important study is an early step in testing a new medicine, BAY2862789, for people with advanced solid tumours, including advanced non-small cell lung cancer. The main goals are to find out if the medicine is safe, determine the right dose, and understand how the body handles it. Researchers will also look at how it might affect different types of tumours. This is a 'first-in-human' study, which means it's the very first time this medicine is being given to people. It's a key part of developing new treatments for cancer, aiming to improve future care.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Bayer AG

Enrolment target

Start

20 Aug 2024

Advanced solid tumors Non-small cell lung cancer

What is this study about?

This study is about a brand new medicine, code-named BAY2862789, that has never been given to people before. It's designed for individuals who have advanced solid tumours, which are cancers that have grown or spread in the body. This includes a specific type of lung cancer called non-small cell lung cancer.

The main purpose of this early study is to learn several important things. Firstly, the research team wants to ensure the medicine is safe when given to people. They will carefully watch for any side effects. Secondly, they need to find the best dose – one that is effective but also keeps side effects to a minimum. They will also investigate how the medicine moves into, through, and out of the body, and how it might affect tumour cells.

Because this is the very first time humans are receiving this specific medicine, it's called a 'first-in-human' study. These early studies are crucial for gathering basic information about new treatments. The findings from this research will help decide if the medicine can be tested further in larger studies, moving us closer to potentially new ways to treat cancer.

Key takeaways

This is an early-stage study testing a brand new cancer medicine.
It's for adults with advanced solid tumours, including advanced non-small cell lung cancer.
The main goals are to check safety, find the right dose, and understand how the medicine works.
Participation involves regular clinic visits and tests.
There are potential benefits and risks, which will be fully explained.
You can stop taking part at any time.

Who may be eligible?

This study is looking for adults aged 18 or older who have advanced solid tumours. This includes people with advanced non-small cell lung cancer.

To be considered, your healthcare team will check if your cancer and overall health meet specific criteria detailed in the study plan. This helps make sure the study is safe for you and that the results will be clear.

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 an advanced solid tumour?
Has your doctor confirmed you have advanced non-small cell lung cancer (if applicable)?
Are you generally able to attend regular clinic visits and tests?

Answer every question to see your result.

What does participation involve?

As this is an early-stage study, taking part would involve regular visits to the study clinic. You would receive the study medicine, BAY2862789, and have various tests and check-ups to monitor your health, how the medicine is affecting your body, and any changes in your tumour. These tests might include blood samples, physical examinations, and scans. The total time you spend in the study would depend on how your body responds to the treatment and the study plan, but it will involve ongoing follow-up.

Potential risks and benefits

Potential benefits of taking part could include receiving a new, experimental medicine that might help your condition, though this is not guaranteed as it's a very early study. You would also be contributing valuable information that could help others in the future. However, there are potential risks, as this medicine has never been given to humans before. There could be unknown side effects, and some known side effects might be unpleasant or serious. All risks will be fully explained by the study team. You always have the right to withdraw from the study at any time, for any reason, without affecting your usual medical care.

Locations (1)

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

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Unverified
Spain

Common questions

What is a 'first-in-human' study?

It means this is the very first time the new medicine (BAY2862789) is being given to people, after being thoroughly tested in labs.

What kind of cancers are included in this study?

This study is for people with advanced solid tumours, including a specific type of lung cancer called non-small cell lung cancer.

What is the medicine called?

The medicine has a research code name: BAY2862789.

Will I know if the medicine is working for me?

The study team will monitor your condition with tests and scans and will share relevant information with you as the study progresses.

Can I stop taking part in the study if I want to?

Yes, you can choose to leave the study at any time, for any reason, and it won't affect your future medical care.