Combination Study of Guadecitabine/ASTX727 and Pembrolizumab
This study, called HyPeR, is a Phase 1 clinical trial investigating a new combination of medicines for people with advanced solid tumours that haven't responded well to other treatments. The medicines being tested are Guadecitabine (also known as SGI-110 or ASTX727) and Pembrolizumab (MK3475). The main goal of this first stage of the trial is to find out if combining these two drugs is safe and to determine the best doses to use. Researchers are particularly interested in how patients with lung cancer that has become resistant to certain previous treatments might respond. This trial will help us understand more about how these drugs work together.
At a glance
What is this study about?
This study, called HyPeR, is a Phase 1 clinical trial. Clinical trials are research studies that test new medical treatments in people. Phase 1 trials are usually the first step in testing a new treatment combination in humans. Their main purpose is to check for safety and find the best dose, rather than to see how effective the treatment is at this early stage.
The study is looking at combining two different types of medicines: Guadecitabine (also known as SGI-110 or ASTX727) and Pembrolizumab (MK3475). Guadecitabine is a drug that works by changing how certain genes in cancer cells behave. Pembrolizumab is an immunotherapy drug that helps your body's own immune system fight cancer. The researchers want to see if using these two drugs together could be more effective than using them alone, especially for people whose cancer has become resistant to other treatments.
The study has two main parts. Part A is about finding the right dose – a small group of patients will be given increasing doses of the medicines to see what levels are safe and well-tolerated. Once the best dose is found, Part B will involve more patients to learn more about the safety and early signs of how well the combination works, particularly in certain types of solid tumours, including a specific type of lung cancer.
Key takeaways
- Tests a new combination of two cancer drugs.
- Aims to check for safety and find the best dose.
- For advanced solid tumours, including certain lung cancers.
- Might be an option if standard treatments haven't worked.
- Close monitoring for side effects is provided.
- Participation is voluntary and you can withdraw anytime.
Who may be eligible?
To join this study, people generally need to have a type of advanced solid tumour that hasn't responded to standard treatments, or for which there are no standard treatments available. It's important that you also have a good general health status, with a life expectancy of at least three months.
For some parts of the study, specific conditions apply. For example, if you have non-small cell lung cancer, you might be eligible if your cancer has shown resistance to certain previous immunotherapy treatments. Other solid tumour patients might be considered if their cancer previously responded to immunotherapy but then stopped responding, or if they have a specific type of tumour with certain genetic features (called MSI-High or dMMR).
There will also be specific blood test results that need to be within a healthy range, and your doctor will check these to make sure you can safely take part. The study team will go through all the detailed requirements with you to see if you are a good fit.
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.
- Do you have an advanced solid tumour that hasn't responded to usual treatments?
- Do you have a general life expectancy of at least 12 weeks?
- Are you generally well and active?
- Are your blood test results within a healthy range?
- If you have lung cancer, has it become resistant to certain immunotherapy treatments?
What does participation involve?
If you join the study, you will receive pembrolizumab as an intravenous injection (into a vein) and guadecitabine via a subcutaneous injection (under the skin). The pembrolizumab will usually be given once every three weeks. Guadecitabine will be given once a day for four days within each three-week cycle. You will have regular visits to the clinic for these treatments, as well as blood tests, scans, and other checks to monitor your health and how you are responding to the treatment.
The first part of the study involves a detailed process of increasing doses to find the safest level. The overall duration of your participation will depend on how you respond to the treatment and the study plan, but you will be monitored closely throughout. Regular follow-up appointments will continue even after treatment ends to track your long-term health.
Potential risks and benefits
Locations (2)
- Royal Marsden HospitalVerified postcodeSutton, United Kingdom
- UCLHVerified postcodeLondon, United Kingdom
Common questions
What is a 'Phase 1' study?
Phase 1 studies are the first step in testing a new treatment in people. The main goals are to check for safety and find the best dose to use.
What kind of cancer is this study for?
This study is for people with advanced solid tumours, which are cancers that form solid masses. It includes people with a specific type of lung cancer.
What are Guadecitabine and Pembrolizumab?
Guadecitabine is a drug that changes how cancer cells behave, and Pembrolizumab is an immunotherapy that helps your immune system fight cancer.
How will I receive the treatments?
Pembrolizumab will be given into a vein, and Guadecitabine will be given as an injection just under the skin.
Can I leave the study if I want to?
Yes, you can choose to leave the study at any time, and this will not affect your future medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.