A study to learn how safe the study drug BAY 2416964 (AhR inhibitor) in combination with the treatment pembrolizumab is, how this combination affects the body, the maximum amount that can be given, how it moves into, through and out of the body and its action against advanced solid cancers in adults
This research is testing a new treatment combination for adults with advanced solid cancers. It combines a new drug, BAY 2416964, with an established cancer medicine called pembrolizumab. The main goals are to find out if this new combination is safe, how the body handles it, and the highest dose that can be given safely. Researchers also want to see if it has any effect against the cancer. This is one of the first studies involving people, so it's a very early step in understanding if this treatment could eventually help patients. It aims to gather important information about its safety and how it works.
At a glance
What is this study about?
This study is an early-stage clinical trial, which means it's one of the first times this new drug combination is being tested in people. The main purpose is to learn more about a new drug called BAY 2416964 when it's given alongside a common cancer treatment known as pembrolizumab. Researchers want to understand if this combination is safe for patients with advanced solid cancers. 'Advanced solid cancers' refers to cancers that have grown or spread from where they started, and 'solid' means they form a lump or tumour, affecting parts of the body like the lung, breast, or bowel.
The study will look at several key things. Firstly, it will closely monitor the participants' health to see how safe the combination is and if there are any side effects. Secondly, it will track how the drugs move through the body – how they are absorbed, used, and cleared out. This helps researchers work out the best way to give the treatment. Thirdly, they will try to find the highest dose of BAY 2416964 that can be given safely when combined with pembrolizumab. Finally, they will observe if this new combination shows any promise in treating advanced solid cancers.
Understanding how new treatments work and what their effects are is a crucial step in developing better ways to fight cancer. By taking part in such a study, patients help doctors gain vital knowledge that can benefit many others in the future.
Key takeaways
- This study tests a new drug combination for advanced solid cancers.
- It aims to check safety, how the body uses the drugs, and the right dose.
- The study includes adults aged 18 and over, both men and women.
- Participation involves regular hospital visits for treatment and check-ups.
- You could gain access to a new treatment, but there are potential risks and no guaranteed benefits.
Who may be eligible?
To join this study, you must be at least 18 years old. There is no upper age limit, meaning older adults are also welcome to be considered.
Both men and women can take part in this research. The study includes people with different types of advanced solid cancers. However, there will be other specific medical checks and requirements that your doctor will discuss with you to see if the study is a good fit for your individual health situation.
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 at least 18 years old?
- Do you have an advanced solid cancer?
- Are you able to travel to a study site for regular appointments?
- Are you willing to follow the study's treatment and monitoring plan?
What does participation involve?
If you decide to take part, you would receive the study drugs according to a set plan. This would involve regular visits to the hospital or clinic for check-ups, assessments, and to receive your treatment. These visits will likely include blood tests, physical examinations, and possibly scans to see how your body is reacting and how the cancer is responding.
The exact number of visits, how long each visit lasts, and the total duration of your participation would be explained in detail by the study team. You would be carefully monitored throughout the study, and there would be follow-up appointments even after you stop receiving the study medication to ensure your well-being. The study team will provide all the necessary medication as part of your participation.
Potential risks and benefits
Locations (1)
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Common questions
What kind of cancer is this study for?
This study is for adults with advanced solid cancers, which means cancers that have spread from where they started and form a lump or tumour.
What does 'advanced solid cancers' mean?
It means cancers that have grown or spread to other parts of the body, and they started as a solid lump or mass, like breast, lung, or bowel cancer.
Is this a new medicine?
Yes, one of the drugs, BAY 2416964, is new, and this study is looking at it in combination with another established cancer drug called pembrolizumab.
What is the main goal of this study?
The main goal is to find out if the new drug combination is safe, how the body handles it, the highest safe dose, and if it shows any signs of helping treat advanced solid cancers.
How old do I need to be to join?
You need to be at least 18 years old to be considered for this study. There is no upper age limit.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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