A Phase 1 open-label, first-in-human, multi-center, dose escalation and dose expansion study of CLN-619 administered alone or in combination with pembrolizumab in patients with advanced solid tumors.
This study is looking into a new treatment called CLN-619 for individuals who have advanced solid tumors, which are cancers that form a lump, such as lung, cervical, womb, ovarian, breast, or bowel cancers. It’s a very early-stage study, meaning it’s the first time this new medicine is being given to people. Doctors want to find out if CLN-619 is safe, understand its effects on the body, and work out the best dose to use. The medicine might be given on its own or together with another cancer drug called pembrolizumab. This research is important because it could lead to new ways to treat these types of cancer in the future.
At a glance
What is this study about?
This study is a research project exploring a new medicine called CLN-619. It’s designed for people who have advanced solid tumors. Solid tumors are a type of cancer that forms a lump in the body, such as non-small cell lung cancer, cervical cancer, womb cancer, ovarian cancer, breast cancer, or bowel cancer. 'Advanced' means the cancer has grown or spread.
This is a very early-stage study, often called a 'Phase 1' study. This means it's the first time this new medicine is being given to people. The main goals at this stage are to make sure the medicine is safe, to see what effects it has on the body, and to figure out what the right dose of the medicine should be. Researchers are interested in giving CLN-619 by itself or in combination with an existing cancer medicine called pembrolizumab, to see if giving them together is even more helpful.
The information gathered from this study is really important. It helps doctors understand if CLN-619 could be a promising new treatment option for people with advanced solid tumors in the future. It’s an essential step in developing new medicines and improving care for cancer patients.
Key takeaways
- This is a first-in-human study of a new cancer medicine, CLN-619.
- It's for people with advanced solid tumors, including lung, breast, and gynaecological cancers.
- The main goals are to check safety and find the right dose, alone or with pembrolizumab.
- You'll have regular hospital visits for treatment and monitoring.
- Participation is voluntary, and you can withdraw at any time.
Who may be eligible?
To be considered for this study, you would generally need to be an adult, aged 18 years or older, with no upper age limit specified. The study is open to both men and women.
You would need to have certain types of advanced solid tumors that have usually been treated before and have continued to grow or come back. The specific types of cancer include non-small cell lung cancer, cervical cancer, womb cancer, ovarian cancer, breast cancer, or bowel cancer.
There will be other detailed health checks to make sure your overall health is suitable for taking part. This is to ensure your safety throughout the study and that the results are as clear as possible. These checks often involve looking at your past medical history, current health conditions, and any other medications you might be taking.
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 tumor, such as lung, cervical, womb, ovarian, breast, or bowel cancer?
- Have you usually had treatment for your cancer before?
- Are you able to attend regular hospital appointments for treatment and check-ups?
What does participation involve?
If you decide to take part in this study, the doctors and nurses will explain everything in detail. You will receive the new study medicine, CLN-619, and in some cases, you might also receive pembrolizumab. The medicine will likely be given to you in a hospital or clinic setting, and you'll have scheduled appointments for your treatment.
Throughout the study, you will have regular visits to the clinic. During these visits, doctors will perform various assessments to monitor your health and how the treatment is affecting you. This will include physical exams, blood tests, and scans (like CT or MRI scans) to check the cancer. These tests are important to see if the medicine is working and to watch for any side effects.
The total length of time you participate in the study can vary. It will involve an initial treatment period and then a follow-up period to continue monitoring your health and the cancer. The study team will explain the exact duration of your commitment.
Potential risks and benefits
Locations (2)
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Common questions
What does 'Phase 1' mean?
Phase 1 means this is the very first time this new medicine is being given to people. Doctors want to check if it's safe and find the right dose.
What types of cancer is this study for?
This study is for people with advanced solid tumors, which include certain types of lung, cervical, womb, ovarian, breast, and bowel cancers.
Will I get CLN-619 alone or with another drug?
You might receive CLN-619 by itself, or together with an existing cancer drug called pembrolizumab. The study aims to look at both approaches.
How long would I be in the study?
The exact length of time varies, but it will involve a treatment period and then a follow-up period. The study team will give you all the details.
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 medical care in the future.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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