A First-in-Human Clinical Study with ABBV-CLS-579 alone and in combination in Patients with Advanced Tumor Cancers
This research study is looking at a new investigational drug called ABBV-CLS-579. It's for adults whose cancer has spread to other parts of the body (metastatic) or grown significantly (locally advanced). This is the very first time this new medicine is being given to people, so the main aim is to understand if it's safe and how the body reacts to it. Researchers will also look at how it works when given alone and when combined with other treatments. This is a very early stage of research, helping scientists learn more about potential new ways to treat cancer.
At a glance
What is this study about?
This study is about a new medicine called ABBV-CLS-579. It's designed for adults who have advanced cancer, meaning their cancer has either spread to different parts of the body (this is called metastatic cancer) or has grown a lot in its original location (known as locally advanced cancer). The goal of this research is to see if this new medicine is safe for people and how their bodies handle it. It's like taking the very first steps in understanding a new treatment.
Because this is the first time humans are receiving ABBV-CLS-579, it's called a 'First-in-Human' study. This is a crucial early stage of clinical research. Scientists will be carefully watching to see how patients respond to the medicine, both when it's given on its own and when it's given alongside other treatments. This helps them learn if it could be a useful treatment option in the future.
Learning about new medicines in studies like this is very important for improving cancer care. The information gathered will help doctors and researchers understand more about ABBV-CLS-579, including any side effects it might have and how well it might work. This knowledge guides the development of potential new therapies for people living with cancer.
Key takeaways
- This study is testing a new cancer medicine, ABBV-CLS-579, for the first time in humans.
- It's for adults (18+) with advanced cancer that has spread or grown extensively.
- The main goal is to check the medicine's safety and how the body reacts to it.
- Participation involves regular clinic visits for medication and health checks.
- You might not directly benefit, but your involvement helps future cancer research.
- You can stop participating at any time without affecting your medical care.
Who may be eligible?
To be considered for this study, you need to be an adult, 18 years old or older. There is no upper age limit. The study is open to both men and women.
Your doctor will check if your cancer is advanced. This means it has either spread to other areas of your body, or it has grown significantly in its original location. They will also look at other specific health factors to make sure that taking part in the study would be safe for you.
It's important to remember that not everyone with advanced cancer will be able to join. The research team will go through a detailed checklist to ensure the study is right for you and that you meet all necessary health 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?
- Has your doctor told you that you have advanced cancer?
- Is your cancer metastatic (spread) or locally advanced (grown significantly)?
- Are you comfortable with regular hospital visits and medical tests?
- Are you able to understand and sign an informed consent form?
What does participation involve?
Taking part in this study would involve regularly visiting the study clinic for check-ups and assessments. The study team would give you the new medicine, ABBV-CLS-579, either by itself or along with other treatments, depending on the study plan. These visits will include tests such as blood samples, scans, and physical examinations to see how you are responding to the medication and to monitor your health.
There will be a set schedule for these visits and assessments. The study duration will vary for each person, but you will receive clear information about how long your participation is expected to be. You'll be closely monitored throughout your time in the study and during any follow-up appointments after you stop receiving the medication.
Potential risks and benefits
Locations (2)
- —UnverifiedSpain
- —UnverifiedFrance
Common questions
What is ABBV-CLS-579?
It's a new medicine being tested for the first time in people to see if it's safe and how it works in advanced cancers.
Who can join this study?
Adults, aged 18 and over, with advanced cancer (either spread or significant local growth), men and women are welcome.
Will I get this new medicine alone, or with other treatments?
Depending on the study plan, you might receive ABBV-CLS-579 by itself or in combination with other existing treatments.
What does a 'First-in-Human' study mean?
It means this is the very first time this specific medicine is being given to people, so safety and understanding how it works are the main goals.
Can I stop participating if I want to?
Yes, you can choose to leave the study at any point, and your decision will not affect your regular 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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