Phase 1b Study to Evaluate ATP128, VSV-GP128 and BI 754091, in Patients With Stage IV Colorectal Cancer
This study is for people in the UK with advanced bowel cancer (also called colorectal cancer) that has spread to other parts of the body. It's a 'Phase 1b' study, which means it's an early stage to check the safety and how well people tolerate new treatments, rather than how effective they are. Researchers are testing a potential new vaccine called ATP128, sometimes on its own, and sometimes combined with a drug called BI 754091 (Ezabenlimab). They are also looking at using ATP128 with another vaccine called VSV-GP128, along with BI 754091. These treatments aim to help the body's immune system fight the cancer. The study will involve around 96 patients across different groups, depending on their specific cancer type and previous treatments.
At a glance
What is this study about?
This study is an early-stage clinical trial (called a 'Phase 1b study') looking into new ways to treat advanced bowel cancer, which doctors call colorectal cancer. When cancer is 'Stage IV' or 'metastatic', it means it has spread from where it started to other parts of the body, often to the liver. For this type of cancer, standard treatments might not always work as well as hoped, especially for a type of bowel cancer known as 'microsatellite stable' (MSS) where certain existing immune treatments haven't shown much benefit.
The main goal of this study is to find out if the new treatments are safe and if people can tolerate them well. It's not primarily about seeing how effective they are at shrinking tumours, but that's something researchers will also keep an eye on. The treatments involve a potential new vaccine called ATP128. Vaccines usually help train your body's immune system to fight off infections, but in this case, the idea is to train it to fight cancer cells. This vaccine might be given on its own, or together with a drug called BI 754091 (also known as Ezabenlimab), which is designed to block a specific pathway that cancer cells use to hide from the immune system. Another part of the study will combine the ATP128 vaccine with a second vaccine, VSV-GP128, and the BI 754091 drug.
Researchers hope that by using these new treatments, especially the vaccine designed to make cancer more visible to the immune system and the drug that helps strengthen the immune response, they might be able to offer new options for people with advanced bowel cancer. The study is particularly interested in patients whose cancer doesn't respond to some existing immune therapies. Around 96 patients will take part, divided into different groups depending on their previous treatments and how their cancer has behaved. This will help the researchers understand which combinations work best and are safest for different individuals.
Key takeaways
- New treatments for advanced bowel cancer are being tested.
- The study focuses on safety and tolerability of new vaccines and drugs.
- Participants must have Stage IV bowel cancer that has spread.
- You'll be closely monitored with regular hospital visits and tests.
- This is an early-stage study, so outcomes are not fully known.
Who may be eligible?
To join this study, you need to be at least 18 years old and have advanced bowel cancer (Stage IV) that has been confirmed by a doctor. You would have already received standard treatments for your cancer, but these treatments haven't fully worked or stopped working.
Your general health needs to be good enough to take part. This includes having blood test results (for your kidneys, liver, and blood cells) within a healthy range, and you should be able to look after yourself with minimal help. You'll also need to have at least one part of your cancer that can be measured on scans and, for one group, a liver lesion that doctors can take samples from repeatedly.
There are also specific requirements depending on which group you might join. For example, some groups require your cancer to be stable or have partially responded to your current treatment, and some focus on cancer that has spread only to the liver. The research team will carefully check all these details to make sure the study is 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 at least 18 years old?
- Do you have advanced bowel cancer (Stage IV) that has spread?
- Have you already had standard treatments for your bowel cancer?
- Are your general health and blood test results within a healthy range?
- Do you have at least one part of your cancer that can be measured on scans?
What does participation involve?
If you decide to join this study, you'll first have several checks to make sure it's safe for you. These will include blood tests, health checks, and scans. Depending on the group you're in, you might receive the ATP128 vaccine alone, or in combination with the drug BI 754091. Some groups will also receive a second vaccine, VSV-GP128.
The treatments will be given over a period of time, and you'll have regular visits to the hospital for further blood tests, health checks, and scans to see how you're doing and how the treatment is affecting you. For some participants, there will be a requirement for two small samples (biopsies) to be taken from a liver tumour, one before treatment and one during treatment. The exact number of visits and the total length of your participation will depend on your specific treatment plan and how you respond, but the research team will explain everything thoroughly.
Potential risks and benefits
Locations (12)
- Honor Health InstituteVerified postcodeScottsdale, United States
- University of Southern CaliforniaVerified postcodeLos Angeles, United States
- University of Colorado Anschutz Medical CampusVerified postcodeAurora, United States
- NYU Langone HealthVerified postcodeNew York, United States
- Weill Cornell MedicineVerified postcodeNew York, United States
- Duke Cancer InstituteVerified postcodeDurham, United States
- University of Texas, MD Anderson Cancer CenterVerified postcodeHouston, United States
- University Hospital AntwerpenVerified postcodeEdegem, Belgium
- University Hospital LeuvenVerified postcodeLeuven, Belgium
- University Medicine MainzVerified postcodeMainz, Germany
- University Hospital ZurichVerified postcodeZurich, Switzerland
- Geneva University HospitalsVerified postcodeGeneva, Switzerland
Common questions
What kind of cancer is this study for?
This study is for people with advanced bowel cancer (colorectal cancer) that has spread to other parts of the body.
What are the new treatments being tested?
The study is testing a potential new vaccine called ATP128, a drug called BI 754091, and sometimes another vaccine called VSV-GP128, both alone and in combinations.
Is this treatment a cure for cancer?
This is an early-stage study to check the safety and how well people tolerate the new treatments. It's not primarily about finding a cure, but rather exploring new treatment options to improve care for advanced bowel cancer.
Will I get to choose which treatment I receive?
You will be placed into a specific group based on your cancer type and previous treatments. The study is not set up for you to choose your treatment.
What does a 'liver lesion amenable to repeated biopsy' mean?
This means you have a spot on your liver (where the cancer has spread) that can be safely accessed to take small samples (biopsies) more than once for testing.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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