First-in-Human Trial of DS3610a in Participants with Advanced Solid Tumors
This research study is about a new medicine called DS3610a. It's the first time this medicine is being given to people, specifically those with advanced solid cancers. The main goals of this very early stage (Phase 1) trial are to find out if DS3610a is safe, to see what side effects it might cause, and to understand how the body uses and gets rid of it. Doctors are also looking for the best dose to give. You won't have received DS3610a before. This kind of study helps scientists learn if new treatments have the potential to help patients in the future.
At a glance
What is this study about?
This study is a very important first step for a new medicine called DS3610a. It's what doctors call a 'first-in-human' trial, meaning it's the very first time this particular drug is being tested in people. The main aim is to understand how the medicine behaves in the human body, rather than focusing on how well it treats the cancer at this early stage. Think of it like a brand-new car model being tested for safety and basic performance before it's ready for general use.
The study is for people who have advanced solid tumours. 'Solid tumours' are cancers that form a lump, as opposed to blood cancers like leukaemia. 'Advanced' means the cancer has grown or spread and isn't responding well to standard treatments, or that standard treatments are no longer an option. The new medicine, DS3610a, is an 'investigational medicine', which means it's still being researched and is not yet available for general use.
The main things doctors will be looking at are whether the medicine is safe, what possible side effects it might have, and how much of it the body can handle without too many problems. They will also study how the medicine gets into your blood, how long it stays there, and how your body gets rid of it. This information is crucial for deciding if DS3610a can move forward to later studies where doctors will start to look more closely at its potential to treat cancer.
Key takeaways
- This is the first study of this new medicine (DS3610a) in humans.
- It's for people with advanced solid cancers.
- The main goals are to check safety and how the medicine acts in the body.
- Potential benefits for your cancer are unknown at this early stage.
- You will be closely monitored by the study team.
- Participation is voluntary and you can leave at any time.
Who may be eligible?
To join this study, you need to be an adult, at least 18 years old, and have advanced solid cancer that has grown or spread despite trying other treatments, or for which there are no more standard treatment options. Both men and women can take part.
Because this is an early study, there will be very specific health requirements to make sure it is safe for you to take part. For example, your organs like your heart, liver, and kidneys need to be working well, and you might need to have stopped previous cancer treatments for a certain amount of time before starting the study.
The medical team will carefully review your health records and perform some tests to make sure that joining this study is suitable and safe for you. It's important to discuss your full medical history with them.
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 solid cancer that has advanced or spread?
- Have you explored or finished standard treatments for your cancer?
- Are your general health and organ functions (like heart, liver, kidneys) considered good by the doctors?
- Are you able to attend regular hospital visits for treatment and checks?
What does participation involve?
If you decide to join this study, it will involve regular visits to the clinic for medical check-ups, blood tests, and scans to monitor your health and how the medicine is affecting your body. You will be given the study medicine, DS3610a, regularly, and the way you receive it (e.g., as a tablet or through a drip) will be explained to you. You'll have close contact with the study team.
The study might involve a few treatment cycles, and you'll have follow-up visits even after you stop taking the medicine, to make sure everything is okay. The total duration of your participation will depend on how you respond to the treatment and for how long it's safe for you to continue, but early-stage trials can involve several months of active treatment and follow-up.
Potential risks and benefits
Locations (2)
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Common questions
What does 'first-in-human' mean?
It means this is the very first time this new medicine has been given to people. Until now, it's only been tested in labs or on animals.
Will this drug cure my cancer?
At this early stage, the focus is on safety and how the drug works in the body, not on finding a cure. We don't know yet if it will help your cancer.
What are 'advanced solid tumours'?
These are cancers that started as a lump, like breast or lung cancer, and have either grown or spread to other parts of the body, and standard treatments are no longer working well.
What kind of tests will I have?
You'll have regular blood tests, physical exams, and possibly scans to check on your health and how your body is reacting to the new medicine.
Can I leave the study if I change my mind?
Yes, you can choose to leave the study at any time, for any reason. Your decision will not affect 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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