A first in human study to investigate the safety and tolerability of CV6-168 in combination with anti-cancer treatments in patients with advanced cancer.
This study tests an experimental medicine called CV6-168 for adults with advanced cancer. It is a first-in-human trial, which means this medicine has not been given to people before. The main goal is to find out if taking CV6-168 together with other anti-cancer drugs is safe, manageable, and effective. Researchers want to find the best dose of CV6-168 and see how it works alongside other treatments. The hope is that CV6-168 will make chemotherapy work better against cancer cells. Participants take CV6-168 by mouth as capsules over several treatment cycles, lasting around 31 to 34 weeks. Throughout the study, specialist doctors at the Beatson West of Scotland Cancer Centre in Glasgow will monitor participants closely using regular blood tests, heart checks, and scans to ensure their safety and track how their cancer responds.
At a glance
What is this study about?
When cancer reaches an advanced stage, standard treatments can sometimes stop working as well as doctors would like. Medical researchers are always looking for new ways to make current therapies more powerful. This clinical trial is testing a new experimental drug called CV6-168. It is designed to work as a booster alongside chemotherapy, helping standard anti-cancer medicines attack cancer cells more effectively.
This is what is known as a 'first-in-human' Phase I/II trial. Although laboratory tests have shown that CV6-168 is safe enough to begin testing in people, this is the very first time human volunteers are receiving it. Because of this, the study starts with small doses to carefully find out what amount is safest, what side effects might occur, and how the body handles the medicine.
The trial is taking place at the Beatson West of Scotland Cancer Centre in Glasgow. By joining the study, patients can help doctors learn whether this combination of treatments could become a helpful new option for people living with advanced cancer in the future.
Key takeaways
- Tests a brand-new oral medicine, CV6-168, combined with other cancer treatments.
- Aimed at adults aged 18 and over with advanced cancer.
- Main goals are to check safety, find the right dose, and manage side effects.
- Treatment lasts roughly 31 to 34 weeks at a specialist centre in Glasgow.
- Taking part is completely voluntary and you can stop at any time.
Who may be eligible?
This trial is for adults aged 18 and older who have advanced cancer. To take part, you should be fairly active and able to look after yourself in day-to-day life, such as doing light housework or walking around without significant help. You must also be able to swallow capsules, as the study drug is taken by mouth.
Because CV6-168 is a new drug, there are strict rules to protect unborn babies. You cannot take part if you are pregnant or breastfeeding. Both women and men who could potentially have children must agree to use reliable forms of contraception during the trial and for at least six months after their final dose. Men must also agree not to donate sperm during this period.
Your hospital doctor will look closely at your medical history, your general health, and your previous cancer treatments to decide if joining the study is safe and right 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 aged 18 or older?
- Have you been diagnosed with an advanced cancer?
- Are you able to swallow medicine capsules?
- Are you able to carry out your normal daily activities without major help?
- Are you willing to use reliable contraception during and after the study?
What does participation involve?
If you join the trial, you will take CV6-168 as capsules by mouth, alongside standard anti-cancer treatments. Care is split into treatment cycles, and most participants can receive up to 12 cycles. Depending on the exact part of the study you enter, your time taking the medicine will usually last between 31 and 34 weeks.
You will need to visit the hospital regularly for health checks. These visits will include routine blood tests (sometimes using a small soft tube placed in your arm to avoid repeated needle pricks), heart checks such as ECGs or heart scans, and body scans (like CT or MRI scans) to see how your cancer is responding. The doctors may also take small tissue samples called biopsies. After your treatment ends, the research team will continue to check in on your health.
Potential risks and benefits
Locations (4)
- Beatson West of Scotland Cancer CentreCity onlyGlasgow, Scotland
- Belfast City HospitalApproximateBelfast, Northern Ireland
- Freeman HospitalApproximateNewcastle upon Tyne, England
- The Royal Marsden Hospital (surrey)City onlySurrey, England
Common questions
What does 'first-in-human' mean?
It means this is the first clinical trial where CV6-168 is given to people. Before this step, the drug was tested extensively in laboratory studies to check that it was safe to test in humans.
How is the trial medicine taken?
CV6-168 is taken by mouth as capsules. You will take it at home or in the clinic alongside your other cancer treatments, following instructions from the study team.
Where does the study take place?
The trial is based in the UK at the Beatson West of Scotland Cancer Centre, part of NHS Greater Glasgow and Clyde.
Can I leave the study if I change my mind?
Yes. You have the right to withdraw from the trial at any point, for any reason. Your normal medical team will support you and continue your cancer care as usual.
Will this trial cure my cancer?
Because this is an early-stage study, the main aim is to check safety and find the best dose. Doctors hope the combination will help treat the cancer, but it cannot be promised as a cure.
How to find out more
Robert Ladner
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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