First-in-human (FIH) Study of DS-1471a in Subjects with Advanced Solid Tumors
This research study is about a new investigational medicine, DS-1471a, being tested for the first time in people who have advanced forms of cancer. 'Advanced solid tumours' means cancers that have grown or spread in the body. The main aim of this first study is to safely test the new drug and understand how it behaves once it’s in the human body. Researchers will be looking to see if there are any side effects and what dose might be right for future studies. This is a very early stage of testing, so we don't know yet if the drug will be effective in treating cancer.
At a glance
What is this study about?
Imagine scientists creating a brand-new key in the lab, hoping it can unlock a difficult door. This study is similar – it’s about a new medicine called DS-1471a, which has been developed to potentially help people with cancer. 'Advanced solid tumours' is a medical term for cancers (like breast, lung, or bowel cancer) that have grown or spread to other parts of the body.
This particular study is known as a 'First-in-Human' (FIH) or 'Phase I' study. This means it's the very first time this new medicine will be given to people. The main goals at this early stage are not to cure cancer, but to make sure the medicine is safe and to understand how the body handles it. For example, researchers will want to know if it causes any unwanted side effects and how much of the medicine the body can handle without serious problems. They will also look at how long the medicine stays in the body.
Taking part in a study like this is a big decision. It’s important to remember that because it’s a new medicine, we don’t yet know if it will help treat the cancer itself. The information gained from this study is crucial for deciding if DS-1471a should be tested further in larger groups of people. Every new medicine that helps patients today started with these important first steps.
Key takeaways
- This study is testing a brand-new medicine called DS-1471a for advanced cancers.
- It's the very first time the medicine will be given to humans to check safety.
- The main goals are to understand side effects and how the body handles the drug.
- You must be 18 or over; both men and women can participate.
- Participation involves regular clinic visits for monitoring and receiving the medicine.
- You can stop participating at any time without affecting your usual care.
Who may be eligible?
To be able to take part in 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.
The study is open to both men and women. The most important health requirement is that you have 'advanced solid tumours'. This means your cancer has either grown or spread. More specific details about your particular type of cancer and your overall health will be checked by the study team during a careful screening process.
There will be other health checks and requirements to make sure it's safe for you to take part. This could include checking your blood, heart, and kidney function. These checks are in place to protect your well-being throughout the study.
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 cancer (a cancer that has spread or grown)?
- Are you able to attend regular appointments at a clinic or hospital?
- Are you willing to follow the study instructions carefully?
- Have you discussed your interest with your current oncology team?
What does participation involve?
If you decide to take part in this study, you'll first go through a screening period where doctors will check if the study is suitable for you. This will involve various tests and medical assessments. If you meet all the requirements, you will then start receiving the study medication, DS-1471a. This is likely given in a hospital or clinic setting and may involve regular visits.
During the study, you will have regular visits with the study team. They will monitor your health very closely, checking for any side effects and how your body is reacting to the new medicine. This will involve blood tests, physical examinations, and possibly other scans or tests. The number of visits will be explained by the study team and might be more frequent at the start. After you finish receiving the medication, there will be follow-up visits to ensure your health remains stable. The total duration of your participation will depend on how you respond to the treatment and the study plan, but this will be fully explained before you agree to take part.
Potential risks and benefits
Locations (3)
- —UnverifiedBelgium
- —UnverifiedSpain
- —UnverifiedFrance
Common questions
What does 'First-in-Human' mean?
It means this is the very first time this new medicine, DS-1471a, is being given to people. Previous tests would have been done in laboratories or on animals.
Will DS-1471a cure my cancer?
At this early stage (Phase I), the main goal is to check if the medicine is safe and how it works in the body, not to cure cancer. It's too soon to know if it will be an effective treatment.
What does 'advanced solid tumours' mean?
This refers to cancers that have grown or spread. 'Solid tumours' are cancers that form a lump or mass, like breast, lung, or bowel cancer, as opposed to blood cancers.
Are there any costs involved for me?
Usually, in clinical studies, you will not have to pay for the study medication or study-related tests. Any travel costs or other expenses will be discussed by the study team.
Can I leave the study if I change my mind?
Yes, you are free to leave the study at any time, for any reason, without it affecting your future medical care.
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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