A phase 1 study of oral Debio 0123 in combination with carboplatin in patients with advanced solid tumors
This is a very early study, called a Phase 1 trial, for a new medicine named Debio 0123. It's designed to be taken by mouth. Researchers are combining it with an existing chemotherapy drug, carboplatin, to see if it could help patients with advanced solid tumours. The main purpose of this first study is to safely test Debio 0123 in people for the very first time. They want to find the right dose that can be given safely alongside carboplatin and understand any side effects. Advanced solid tumours are cancers that have grown or spread. Anyone aged 18 or over, regardless of their sex, may be able to take part if they meet other health requirements.
At a glance
What is this study about?
This study is about a new medicine called Debio 0123. It's an early-stage study, known as a 'Phase 1' trial, which means it's one of the first times this new medicine is being given to people. The main goals of these types of studies are to find out if the new medicine is safe, to understand what side effects it might cause, and to figure out the best dose to give.
In this particular study, Debio 0123 is being tested together with a chemotherapy drug called carboplatin. Carboplatin is a common treatment for various cancers. Researchers want to see how Debio 0123 works when combined with carboplatin in adults who have advanced solid tumours. 'Advanced' means the cancer may have spread or grown, and 'solid tumours' are cancers that form a lump, rather than liquid cancers like leukaemia.
The information gathered from this study will help doctors learn if this new combination could be a promising future treatment. It's an important step in developing new ways to fight cancer, by carefully testing new approaches. The findings will help decide if the new medicine should be studied further in larger groups of people.
Key takeaways
- This is an early-stage (Phase 1) study for a new cancer medicine.
- It combines a new pill, Debio 0123, with a known chemotherapy, carboplatin.
- The main goals are to find a safe dose and understand side effects for adults with advanced solid tumours.
- Participation involves regular hospital visits for treatment and health checks.
- There are potential benefits and risks, and you can withdraw at any time.
Who may be eligible?
To join this study, you must be an adult aged 18 or older. The study is open to both men and women.
You would need to have an advanced solid tumour, which means a cancer that has spread or is difficult to treat with standard therapies. Your doctors will be able to tell you if your specific cancer type and stage fit this description.
Beyond these basic requirements, there will be other important health checks. For example, your general health, how well your organs are working, and any other medical conditions you have will be carefully looked at by the study doctors. These checks are to make sure it's safe for you to take part.
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 a diagnosis of an advanced solid tumour?
- Are you able to take medicines by mouth?
- Are you able to travel to regular hospital appointments?
- Are you willing to follow treatment instructions and have regular checks?
What does participation involve?
If you decide to take part in this study, you would receive the new medicine, Debio 0123, usually taken by mouth, along with carboplatin, which is given as an injection or drip. You would have regular visits to the hospital or clinic to see the study doctors and nurses. During these visits, they would monitor your health carefully, take blood tests, and check for any side effects you might be experiencing.
The treatment schedule and number of visits would vary, but it's likely you would have weekly or bi-weekly visits initially. You would be given instructions on how to take the medicine and what to look out for. After the main treatment period, there would likely be follow-up visits or phone calls to monitor your long-term health and any lasting effects. The total duration of your involvement could range from several months to perhaps over a year, depending on your individual response and the study plan.
Potential risks and benefits
Locations (2)
- —UnverifiedNetherlands
- —UnverifiedSpain
Common questions
What is a 'Phase 1' study?
A Phase 1 study is the first step where a new medicine is tested in people. Its main aims are to find a safe dose and understand any side effects.
What is Debio 0123?
Debio 0123 is a new medicine being investigated. In this study, it's being tested alongside carboplatin, a common cancer drug.
What are 'advanced solid tumours'?
These are cancers that started as a solid lump and may have grown or spread, and are often no longer responding to standard treatments.
Will I definitely get better if I join this study?
No, there's no guarantee of getting better. The aim is to find out if the new medicine is safe and if it shows any promise, not necessarily to cure your cancer at this early stage.
Can I leave the study if I change my mind?
Yes, you can leave the study at any time, for any reason. Your decision will not affect your ongoing medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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