A Safety, Pharmacokinetic and Clinical Activity Study of NUC-7738 in Patients With Advanced Solid Tumours and Lymphoma
This research study is looking at a new medicine called NUC-7738 for people who have advanced cancers, including solid tumours and lymphoma. It's a two-part study. The first part focuses on finding the safest and best dose of NUC-7738 when given alone. Doctors will check for any side effects and how the body handles the drug. The second part will then use that chosen dose to see how well NUC-7738 works in more people with these cancers. Some patients with skin cancer (melanoma) will also receive NUC-7738 in combination with another approved cancer drug called pembrolizumab. The overall goal is to understand if NUC-7738 can be a useful treatment option for these serious conditions.
At a glance
What is this study about?
This study is called a Phase I/II trial, which means it has two main parts. In the first part (Phase I), the goal is to carefully test a new drug called NUC-7738. This drug will be given into the bloodstream, either once a week or once every two weeks, to a small group of people with advanced solid tumours. During this stage, doctors will pay very close attention to how safe the drug is and what side effects it might cause. They will slowly increase the dose to find the highest amount that can be given without causing too many problems. This helps them find the 'best' dose to use later on.
Once the safest and most effective dose is found, the study moves into its second part (Phase II). Here, more people with advanced solid tumours will receive NUC-7738 alone at the chosen dose. This part aims to get a clearer picture of how well the drug works against the cancer. Some people with a type of skin cancer called melanoma will also be included. For some of these melanoma patients, NUC-7738 will be given alongside an existing cancer medicine called pembrolizumab, to see if the combination works better.
Finally, the study will also look at whether NUC-7738 alone can help people with lymphoma, which is a cancer affecting the immune system. This research is important because it helps scientists understand if NUC-7738 could become a future treatment option for various advanced cancers, either on its own or with other medicines.
Key takeaways
- This study is testing a new drug, NUC-7738, for people with advanced cancers.
- It aims to find the safest dose and see how well NUC-7738 works, alone or with pembrolizumab.
- The study includes patients with advanced solid tumours, melanoma, and lymphoma.
- Participants receive the drug through a drip and have regular check-ups.
- It's a way to access a new treatment and help medical research.
Who may be eligible?
To join this study, you must be 18 years old or over. If you have an advanced solid tumour, the cancer needs to be actively measurable by doctors. If you have advanced melanoma and are considering the combination treatment, you will need to have tried one or two previous treatments for your advanced cancer, and at least one of those must have included a specific type of immunotherapy (like PD-1/PD-L1 blocking drugs) that didn’t fully work for you.
If you have lymphoma, your cancer must be one that hasn’t responded well to standard treatments, or where there isn’t a standard treatment available. For people with solid tumours taking NUC-7738 alone in Phase II, you should not have had more than three previous treatments for the advanced stage of your cancer.
Additionally, all participants must generally be in good health for someone with cancer, be able to carry out daily activities with little difficulty, and have a life expectancy of at least three months. Your liver, kidney, and blood test results need to be within a healthy range. If you are a woman who could become pregnant, you need to have a negative pregnancy test and agree to use reliable contraception during the study. Similarly, men who could father children must also agree to use effective contraception.
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 tumour, melanoma, or lymphoma?
- Can you manage most of your daily activities without much help?
- If you have advanced melanoma, have you tried one or two previous treatments, including a specific immunotherapy?
- If you are a woman who could become pregnant, are you able to use effective birth control and have a negative pregnancy test?
- Have you discussed this study with your personal doctor?
What does participation involve?
If you decide to take part, you will receive NUC-7738, which is given through a drip into a vein. Depending on which part of the study you are in, this might be once a week or once every two weeks. For some, it might be combined with pembrolizumab, also given through a drip.
You will have regular appointments for blood tests, physical checks, and scans to monitor your health and how the cancer is responding. The doctors will also look for any side effects. The study involves a period of treatment, followed by ongoing monitoring. The exact number of visits and the total length of your participation will depend on which group you are in and how you respond to the treatment, but these details will be fully explained to you by the study team.
Potential risks and benefits
Locations (9)
- Cambridge University Hospitals NHS Foundation Trust (Addenbrookes Hospital)Verified postcodeCambridge, United Kingdom· Recruiting
- Edinburgh Cancer Centre, Western General HospitalVerified postcodeEdinburgh, United Kingdom· Recruiting
- The Beatson West of Scotland Cancer CentreVerified postcodeGlasgow, United Kingdom· Recruiting
- University College London HospitalVerified postcodeLondon, United Kingdom· Recruiting
- The Royal Marsden NHS Foundation TrustVerified postcodeLondon, United Kingdom· Recruiting
- The Christie NHS Foundation TrustVerified postcodeManchester, United Kingdom· Recruiting
- Freeman HospitalVerified postcodeNewcastle, United Kingdom· Recruiting
- Oxford University Hospitals NHS Foundation TrustVerified postcodeOxford, United Kingdom· Recruiting
- Lancashire Teaching Hospitals NHS Foundation Trust, Royal Preston HospitalVerified postcodePreston, United Kingdom· Recruiting
Common questions
What is NUC-7738?
NUC-7738 is a new medicine being tested to see if it can help treat advanced cancers like solid tumours and lymphoma.
What does 'advanced solid tumours' mean?
It refers to cancers that have grown or spread from where they started in the body.
What is pembrolizumab?
Pembrolizumab is an approved cancer drug that helps your body’s immune system fight cancer cells, and in this study, it's being tested with NUC-7738 for some patients.
What are the 'phases' of a clinical trial?
Clinical trials often have phases. Phase I checks safety and dose, and Phase II checks how well the drug works at the chosen dose.
Will I have to pay to participate?
No, you will not have to pay for the study drug or study-related procedures. Funding for clinical trials comes from various sources.
How to find out more
NuTide:701 Project Manager
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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