A First-in-human study to learn how safe the study drug BAY2965501 is, find the best dose (single drug & combination), how it affects the body, what maximum amount can be given, how it moves into, through and out of the body, how it acts on different tumors in participants with advanced solid tumors
This research is a very early study of a new medicine called BAY2965501. It's the first time this medicine is being given to people. The main goals are to check how safe it is, find the right amount (dose) to give, and see how the body handles it. Researchers also want to understand how the medicine moves around the body, how long it stays there, and whether it shows any signs of working against different types of advanced solid cancers. It’s a key step in learning if this new medicine could help people with cancer in the future.
At a glance
What is this study about?
This study is a very important first step for a new medicine called BAY2965501. Think of it like a brand new car model – before it can be sold to everyone, it needs careful testing to make sure it’s safe and works well. This study is similar, but for a medicine that might one day help people with cancer.
The main aim is to understand how safe BAY2965501 is when given to people. Researchers will start with very small doses and gradually increase them to find a dose that is well-tolerated. They also want to see how the medicine acts in the body, such as how it's absorbed, where it goes, how long it stays there, and how the body gets rid of it. This helps them understand the best way to give the medicine and what effects it might have.
Another important part is to see if the medicine has any effect on different types of advanced solid cancers. This study will help doctors learn a lot about this new treatment, which is crucial for deciding if it moves on to bigger studies in the future. It’s about gathering fundamental information to help improve cancer care down the line.
Key takeaways
- It's the first time this new cancer medicine (BAY2965501) is being tested in people.
- The main goals are to check its safety and find the best dose.
- It's for people aged 18 or over with advanced solid tumors.
- Participation involves regular clinic visits, tests, and receiving the study medicine.
- There are potential risks and benefits, and you can withdraw anytime.
Who may be eligible?
To join this study, you must be at least 18 years old. People of any gender can take part.
Because this is an early study looking at a new medicine for serious conditions, there will be other specific health requirements. These usually involve having a diagnosis of advanced solid cancer and having already tried standard treatments. It's important that your overall health is stable enough to be able to take part in the study and potentially tolerate the new medicine.
During your discussions with the study team, they will carefully review your full medical history and current health to determine if this study is suitable for you. They will check all the detailed requirements to make sure it's safe for you to participate.
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?
- Have you been diagnosed with an advanced solid tumor?
- Are you able to travel to the study clinic for appointments?
- Are you willing to follow the study's schedule of visits and tests?
- Have you discussed this trial with your doctor?
What does participation involve?
Taking part in this kind of study usually involves several visits to the clinic. At these visits, you’ll have regular check-ups, which may include blood tests, urine tests, and sometimes scans, to monitor your health and see how the study medicine is affecting your body. You will receive the study medicine, BAY2965501, at these visits, possibly as a single dose or in combination with other treatments, depending on the study's plan.
The number of visits and the types of tests will depend on which part of the study you are in. Initially, visits might be quite frequent to closely observe how you respond to the new medicine. Over time, if you continue on the study, the visits might become less frequent. There will also be follow-up appointments after you stop taking the study medicine to ensure your health is monitored. The total time you spend in the study will vary, but you’ll be given a clear schedule from the outset.
Potential risks and benefits
Locations (2)
- —UnverifiedBelgium
- —UnverifiedSpain
Common questions
What kind of cancer is this study for?
This study is for people who have advanced solid tumors, which means cancers that have spread and are no longer treatable with standard methods.
Is this medicine available to everyone?
No, this is a new medicine not yet approved for general use. It's only available to people who participate in this specific clinical trial.
Will I definitely get the new medicine?
Yes, in this type of study, all participants receive the new medicine. There is no placebo (dummy treatment) arm.
How long will I be in the study?
The duration can vary for each person. You will stay in the study for as long as the treatment is helping you and is safe, or until the study concludes.
Who is paying for this study?
This study is sponsored by a pharmaceutical company, most likely the one that developed the medicine.
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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