A Multicenter, Multi-Part, Phase 1/2 Study of EIK1005 as Monotherapy and in Combination with Pembrolizumab in Participants with Advanced Solid Tumors, including Checkpoint Inhibitor Naïve Participants with Microsatellite Instability High (MSI-H) or Mismatch Repair Deficient (dMMR) Tumors
This research study, called EIK1005-001, is testing a new medication named EIK1005. It's being given by itself or together with an existing cancer treatment called Pembrolizumab. This study is for adults who have different types of advanced cancers. Some participants may have cancers that are Microsatellite Instability High (MSI-H) or Mismatch Repair Deficient (dMMR) and haven't had previous checkpoint inhibitor treatment. The main goals are to check the safety of EIK1005, including any side effects, and to find the right dose. Researchers will also look at how well the treatment shrinks tumours or stops them from growing. This is a Phase 1/2 study, which means itâs in the early stages of human testing.
At a glance
What is this study about?
This study is investigating a new potential cancer treatment called EIK1005. It will explore how safe this new drug is when given alone, and also when combined with a drug already approved for cancer treatment, Pembrolizumab. The study is designed for adults who have advanced solid tumours, which are cancers that have grown or spread. A particular group of patients being studied are those whose cancers have a specific genetic feature (called MSI-H or dMMR) and haven't yet been treated with a type of drug called a checkpoint inhibitor.
This is an early-stage study, known as Phase 1/2. In Phase 1, the main focus is on carefully checking for any serious side effects and finding the best and safest dose of EIK1005. Participants may be given different strengths of EIK1005 tablets (10mg, 50mg, or 200mg). As the study moves into Phase 2, researchers will continue to monitor safety but will also pay close attention to how well the treatment works against the cancer.
To understand how well the treatment works, doctors will measure if tumours shrink, stop growing, or disappear. They will also track the time until the cancer shows signs of progression. Another important part of the study involves taking blood samples to understand how the body handles the drug, such as how it's absorbed and cleared.
Key takeaways
- This study is testing a new cancer drug, EIK1005, for adults with advanced solid cancers.
- It aims to find out if EIK1005 is safe and effective, both alone and with another drug, Pembrolizumab.
- Some participants will have specific cancer types (MSI-H or dMMR) and haven't had certain treatments before.
- You'll have regular checks, scans, and blood tests to monitor your health and the cancer.
- You can stop participating at any time if you wish.
Who may be eligible?
To be considered for this study, you must be at least 18 years old. Both men and women are welcome to take part.
You would need to have certain types of advanced solid tumours. This means your cancer has spread or is considered advanced. Some parts of the study specifically look for people with certain genetic changes in their cancer (MSI-H or dMMR) who have not had a specific type of cancer treatment before (checkpoint inhibitors).
There might be other specific health requirements or conditions that would determine if you can join. The study team will review your medical history carefully to make sure the study is right and safe for you.
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 diagnosis of advanced solid cancer?
- Are you able to attend regular clinic appointments?
- Are you willing to take study medication and have regular tests?
What does participation involve?
Taking part in this study would involve regular visits to the clinic for check-ups and assessments. You would be given the study medication, EIK1005 (as tablets of 10mg, 50mg, or 200mg), either alone or alongside Pembrolizumab (given as an infusion). You will have blood tests taken frequently to check how your body is handling the drug and to see if the treatment is affecting your cancer.
Doctors will regularly take scans (like CT or MRI) to measure your tumours and see if they are shrinking or staying the same. You will also be asked about any side effects you experience. The total length of your participation will depend on how you respond to the treatment and the study's specific design, but it will involve ongoing assessments and follow-up.
Potential risks and benefits
Locations (8)
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Common questions
What does 'advanced solid tumors' mean?
This refers to cancers that have grown or spread from where they started. 'Solid tumors' are cancers that form a lump, unlike blood cancers.
What is EIK1005?
EIK1005 is a new drug being tested. This study aims to find out how safe it is and how well it works against certain cancers.
What is Pembrolizumab?
Pembrolizumab is an approved cancer drug that works by helping your body's immune system fight cancer cells. In this study, EIK1005 may be given with it.
What are 'MSI-H' and 'dMMR' tumors?
These are specific features found in some cancer cells. They can suggest that a cancer might respond differently to certain treatments, like checkpoint inhibitors.
Will I know if I'm getting the new drug or not?
In this early-stage study, all participants will receive EIK1005, either on its own or combined with Pembrolizumab. There isn't a placebo group.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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