Phase 1/1b Multiple-Ascending Dose Study of DF6215 in Patients With Advanced Solid Tumors
This study is an early-stage clinical trial for a new medicine called DF6215. It's for people who have advanced cancer (solid tumours) that has unfortunately spread in their body. The main aim of this study is to carefully test DF6215 to find a safe dose that can be given to patients. Scientists will also be looking at how the medicine moves through the body, what it does, and if it might have any helpful effects on the cancer. This is a "first in human" study, meaning it's one of the first times this new medicine is being given to people. This helps researchers understand if DF6215 could be a promising new treatment option in the future. The study is open to both men and women aged 18 and over.
At a glance
What is this study about?
This study is an early step in testing a new medicine called DF6215. It's designed for people who have advanced solid tumours, which means their cancer has grown or spread. New treatments for cancer are always being researched, and this trial is part of that important work. The study is in its very first phase, often called a 'Phase 1' study. This means it's one of the first times this new medicine is being given to humans. Researchers need to be very careful at this stage.
The main goals of this study are twofold. Firstly, the team wants to find out what dose of DF6215 is safe for people to take. They will start with very low doses and slowly increase them while closely monitoring participants. Secondly, they want to understand how the medicine behaves in the body – how long it stays, how it's absorbed, and how it's broken down. They also hope to see if there are any signs that it might be effective against cancer, although finding effectiveness isn't the main goal at this early stage.
Taking part in a Phase 1 study means you would be helping science discover if a new medicine has the potential to become a treatment in the future. It's a vital step in developing new ways to fight cancer, but it's important to remember that it's a very early investigation.
Key takeaways
- This is an early-stage study (Phase 1) for a new cancer medicine called DF6215.
- It's for people with advanced solid tumours.
- The main aims are to find a safe dose and understand how the medicine works.
- Participation involves regular hospital visits for monitoring and receiving the medicine.
- Potential benefits are unknown at this early stage; potential risks include new side effects.
- You can withdraw from the study at any time.
Who may be eligible?
To join this study, you must be at least 18 years old, and there is no upper age limit. The study is open to both men and women.
The study is specifically looking for people who have been diagnosed with advanced solid tumours. This means you have a type of cancer that started in a solid organ (like the lung, breast, or bowel) and has either grown locally or spread to other parts of your body, and your doctors feel you need more treatment options.
Further specific health checks will be carried out by the study doctors to make sure it's safe for you to take part. This will involve reviewing your medical history and current health to ensure you meet all the detailed requirements.
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 advanced solid tumours?
- Are you willing to have regular medical checks and take a new medicine?
- Are you able to travel to the study site for appointments?
What does participation involve?
If you decide to take part, you would receive the new medicine, DF6215. Since this is a dose-finding study, the amount of medicine you receive would gradually increase as the study progresses, with doctors carefully observing how you respond. You would have regular visits to the hospital or clinic for blood tests, physical examinations, and other checks to see how you are doing and how the medicine is affecting you. The exact number of visits and the assessments involved would be clearly explained by the study team. You would also have follow-up visits after you stop taking the medicine to ensure your health is still being monitored. The total length of your participation would depend on your individual response and the study's plan, but all details would be given to you before you agree to join.
Potential risks and benefits
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Common questions
What kind of cancer is this study for?
This study is for people with advanced solid tumours, which means cancer that started in an organ and has grown or spread.
What does 'Phase 1' mean?
Phase 1 means it's an early-stage study where doctors are giving a new medicine to people for the first time to find a safe dose and see how it works in the body.
Will this medicine cure my cancer?
It's too early to say if this new medicine, DF6215, will cure cancer. The main goal of this study is to find a safe dose.
How long would I be in the study?
The exact duration would depend on your individual response and the study plan, but the team will explain this to you clearly.
Can I stop participating if I want to?
Yes, you can leave the study at any time, for any reason, without affecting your regular 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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