First in Human Study of CDR404 in HLA-A*02:01 Participants With MAGE-A4 Expressing Solid Tumors
This is a very early-stage study looking at a new experimental drug, CDR404, for certain advanced solid cancers that have a specific marker called MAGE-A4. These are cancers that haven't responded well to standard treatments. This is the first time CDR404 is being given to people, so the main goals are to check if it's safe and what dose works best. Researchers will also look for early signs that the treatment might be shrinking tumors. Participants will need to have a specific genetic marker (HLA-A*02:01) and their cancer must have the MAGE-A4 marker for them to be considered for the study.
At a glance
What is this study about?
Imagine your body's immune system as a strong army that fights off invaders like viruses and bacteria. Sometimes, cancer cells can hide from this army. This study is testing a new, experimental medicine called CDR404, which is designed to help your immune system find and attack certain cancer cells more effectively. This specific medicine works by targeting a particular protein called MAGE-A4, which is found on some types of advanced solid cancers. It acts like a 'buddy' system, bringing your immune cells closer to the cancer cells so they can recognise and destroy them.
This is a 'first-in-human' study, which means it’s the very first time this new medicine is being given to people. Because of this, the most important goals are to make sure the treatment is safe and to find the right dose. The researchers will also be carefully watching to see if there are any early signs that the medicine is helping to shrink the cancer. They will also look at how the body handles the medicine.
This type of research is really important because it helps scientists learn about new ways to treat cancers that are difficult to treat with current standard options. While it's early days, studies like this pave the way for new cancer treatments in the future.
Key takeaways
- New experimental medicine for certain advanced solid cancers.
- First time testing this medicine in people, focusing on safety and dosage.
- Targets cancers with a specific marker called MAGE-A4.
- Requires participants to have a specific immune system marker (HLA-A*02:01).
- May offer a new option for hard-to-treat cancers.
- Participation is voluntary, and you can withdraw at any time.
Who may be eligible?
To be considered for this study, you would need to meet several important criteria. Firstly, your doctors would need to confirm that your cancer has a specific marker known as MAGE-A4. Your blood would also be tested to show you have a particular immune system marker called HLA-A*02:01. Your cancer should be advanced, meaning it has spread or cannot be removed by surgery, and it should no longer be responding well to, or you can't tolerate, standard treatments.
You would also need to be generally well, able to perform daily activities with ease, and have your body organs working properly. If you are a woman who could become pregnant, you would need to agree to use effective contraception during the study. The study is for adults aged 18 and over.
There are also some reasons why you might not be able to join. For example, if your cancer has spread to your brain and is causing symptoms, or if you've recently had major surgery. You wouldn't be able to participate if you have serious heart problems, an active infection needing antibiotics, or certain uncontrolled long-term health conditions like active hepatitis, HIV that could lead to AIDS, or an autoimmune disease requiring treatment. Being pregnant or breastfeeding would also exclude you from participating.
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.
- Is your cancer an advanced solid tumour?
- Has your cancer stopped responding to, or can you not tolerate, standard treatments?
- Have your doctors confirmed your cancer has the MAGE-A4 marker?
- Do you know if you have the HLA-A*02:01 immune marker?
- Are you generally well and able to perform daily activities?
- Are you an adult aged 18 or older?
What does participation involve?
If you decide to join this study, you would receive the experimental medicine, CDR404. What taking part involves would depend on the specific stage of the study you are in, but generally, it would include: regular visits to the clinic for check-ups, blood tests, and scans to monitor your health and how the treatment is affecting your cancer. You would also have tests to see how your body processes the medicine and how your immune system responds to it. The clinic visits would likely be more frequent at the beginning of the study, becoming less frequent over time. The total duration of your participation would be discussed with you by the study team, and you would have follow-up appointments even after you stop receiving the medication. Specific details about the frequency of visits and assessments would be fully explained before you agree to participate.
Potential risks and benefits
Locations (18)
- University of MiamiVerified postcodeMiami, United States· Recruiting
- University of MichiganVerified postcodeAnn Arbor, United States· Recruiting
- Providence Cancer InstituteVerified postcodePortland, United States· Recruiting
- Pennsylvania HospitalVerified postcodePhiladelphia, United States· Recruiting
- Universitair Ziekenhuis AntwerpenVerified postcodeAntwerp, Belgium· Recruiting
- Institut Jules BordetVerified postcodeBrussels, Belgium· Recruiting
- Cliniques Universitaires Saint-Luc, UCL OuvainVerified postcodeBrussels, Belgium· Recruiting
- Universitair Ziekenhuis GentVerified postcodeGhent, Belgium· Recruiting
- RigshospitaletVerified postcodeCopenhagen, Denmark· Recruiting
- Istituto Clinico HumanitasVerified postcodeMilan, Italy· Recruiting
- Isituto Europeo di Oncologia (IEO)Verified postcodeMilan, Italy· Recruiting
- Hospital Universitari Vall d'HebronVerified postcodeBarcelona, Spain· Recruiting
Common questions
What does 'first-in-human' mean?
It means this is the very first time this new medicine is being tested in people. This type of study focuses on safety and finding the right dose.
What is MAGE-A4?
MAGE-A4 is a specific protein that can be found on the surface of some cancer cells. This new medicine is designed to target cells that have this protein.
What is HLA-A*02:01?
This is a common marker on some people's immune cells. You'd need to have this particular marker in your body for the medicine to work as intended.
Will this medicine cure my cancer?
This is an early-stage study, so it's too soon to say if this medicine will cure cancer. The main goals are to check safety and look for early signs of how it affects cancer.
What if I feel unwell during the study?
The study team will closely monitor you. You should always tell them about any new or worsening symptoms you experience.
How to find out more
Dimitrios Chondros Chief Medical Officer, CDR-Life
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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