A Phase 1b, Open-Label, Dose-Escalation Trial of the Safety of and Antigen-Specific Immune Responses Elicited by VB.10 NEO in Combination With Atezolizumab in Subjects with Locally Advanced and Metastatic Tumors
This research study is testing a new combination treatment for several types of advanced cancer, including lung, kidney, bladder, and breast cancer. The new treatment involves a medicine called VB.10 NEO, which is designed to help your body's immune system recognise and fight cancer cells, given alongside an already approved cancer drug called atezolizumab. This is an early-stage study (Phase 1b) that mainly focuses on finding the right dose and checking how safe the combination is. It also looks at how your immune system responds to the new treatment. The study is open to adults aged 18 and over, both men and women.
At a glance
What is this study about?
This study is exploring a new way to treat certain advanced cancers. It brings together two types of medicine: VB.10 NEO and atezolizumab. VB.10 NEO is a newer type of drug that works by telling your body's immune system to find and attack cancer cells more effectively. Atezolizumab is an immunotherapy drug that is already approved for some cancers; it also helps your immune system fight cancer, but in a slightly different way. By combining these two treatments, researchers hope to give your body a stronger ability to fight the cancer.
This is a 'Phase 1b' study, which means it's an early step in testing a new treatment. The main goals at this stage are to understand if the new treatment combination is safe for people to take and to figure out what dose works best without causing too many side effects. Researchers will also look at how the combined treatment affects your immune system, hoping to see signs that it's encouraging your body to fight the cancer.
The study involves people with different types of advanced solid tumours, such as some lung, kidney, bladder, and breast cancers, as well as others. The information gathered from this study will help decide if this combination treatment is promising enough to be studied in larger groups of people in the future.
Key takeaways
- This study is testing a new combined treatment for advanced cancers.
- It aims to find a safe dose and understand how the treatment works with your immune system.
- It's an early-stage study (Phase 1b) for several types of advanced solid tumours.
- Participation involves regular hospital visits for treatment and health checks.
- You can stop participating at any time.
Who may be eligible?
To join this study, you need to be an adult, 18 years old or older, with an advanced solid tumour. This includes certain types of lung, kidney, bladder, head and neck, and breast cancers, as well as some stomach, cervical, anal cancers, and those with a specific genetic marker called MSI-high.
Since this is an early-stage study, there will be other specific health requirements that the study doctors will need to check. These are in place to make sure that the treatment is as safe as possible for everyone taking part. Your doctor will carefully review your full medical history to see if this study is right for you.
Both men and women can take part in this study. The medical team will discuss all the detailed requirements with you to determine if you are suitable.
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?
- Have you been diagnosed with an advanced solid tumour, such as certain lung, kidney, bladder, or breast cancers?
- Are you able to travel to the study site for regular appointments?
- Are you generally well enough to start a new treatment?
What does participation involve?
If you decide to take part in this study, you will receive the study medications, VB.10 NEO and atezolizumab, according to a schedule set by the researchers. This will involve regular visits to the hospital for treatment and health checks. During these visits, doctors and nurses will carry out various assessments, which might include blood tests, scans (like CT scans), and physical examinations, to monitor your health, check for any side effects, and see how the treatment is affecting your cancer.
As this is a dose-escalation study, you might start on a lower dose of one of the medications, which could be gradually increased at later stages if it's safe to do so. The exact number of visits and the total length of your participation will depend on how you respond to the treatment and the study plan, but there will be regular monitoring and follow-up for a period after your last dose of treatment.
Potential risks and benefits
Locations (2)
- —UnverifiedGermany
- —UnverifiedSpain
Common questions
What is the main goal of this study?
The main goal is to check if combining two cancer medicines, VB.10 NEO and atezolizumab, is safe and what dose works best, as well as how it affects the body's immune system to fight cancer.
Will I get better from my cancer if I join this study?
This is an early-stage study focusing on safety and how the treatment works. While some people may benefit, there's no guarantee it will cure your cancer. Potential benefits will be discussed with you.
What kind of cancers are being studied?
The study includes various advanced solid cancers like some types of lung, kidney, bladder, head and neck, breast, stomach, cervical, anal cancers, and MSI-high tumours.
How old do I need to be to join?
You need to be 18 years old or older to take part in this study.
Can I stop being in the study if I change my mind?
Yes, you can leave the study at any time, for any reason, and it will not affect your regular medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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