A Study Evaluating the Safety, Pharmacokinetics and Early Efficacy of AVA6000 in Solid Tumours
This study is looking into a new treatment called AVA6000 for various advanced solid tumours, including salivary gland, bladder, ovarian, breast cancer, and a type of soft tissue cancer. It's a 'first-in-human' study, meaning it's one of the first times this drug is being tested in people. The main goals are to check if AVA6000 is safe, how the body handles it, and if it shows any signs of shrinking the tumours. Researchers will start by testing different doses to find the best and safest amount. This study is for people whose cancer has spread or cannot be removed by surgery and who may have already tried other standard treatments.
At a glance
What is this study about?
This research study is trying out a new drug called AVA6000. It's designed for people who have certain types of solid tumours that have either spread to other parts of the body (metastatic) or cannot be removed through surgery (locally advanced).
The main aim of this study is to see if AVA6000 is safe for people to take, how their bodies react to the drug, and if it shows any early signs of helping to treat their cancer. Because this is a very new drug, it's one of the first times it's being given to people. The study is divided into two main parts. The first part will carefully increase the dose of the drug in small steps to find the safest and most effective amount. Once that's established, the second part will explore that recommended dose in more people with specific types of cancer.
The researchers are particularly interested in tumours that have a specific marker called FAP. This study is important because it could offer a new treatment option for people whose cancer hasn't responded well to standard treatments or who can't have those treatments for other reasons. The hope is to find a drug that can help control these cancers more effectively.
Key takeaways
- This study is testing a new drug, AVA6000, for advanced solid tumours.
- It's a first-time human trial focused on safety and early effectiveness.
- For specific advanced salivary gland, bladder, ovarian, breast, and soft tissue cancers.
- Patients must be 18 or older and have cancer with a potential FAP marker.
- You'll receive AVA6000 intravenously on a regular schedule.
- You can withdraw from the study at any time.
Who may be eligible?
To join this study, you must be an adult aged 18 or over.
For the first part of the study, you would need to have a solid tumour that has either spread or can't be removed by surgery. This includes certain types of salivary gland, bladder (urothelial), ovarian, or breast cancer, especially if your current treatment isn't working or you can't have it. If you have a soft tissue sarcoma, you might be eligible if you haven't received specific previous treatments or had a low dose of doxorubicin before.
In the second part of the study, the focus narrows slightly. You might be eligible if you have a high-grade soft tissue sarcoma, salivary gland cancer (that can't be fully removed), or triple-negative breast cancer, and you've had a certain number of previous treatments for your advanced cancer.
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 solid tumour that has spread or cannot be removed by surgery?
- Has your doctor mentioned your tumour might be 'FAP positive'?
- Have you tried standard treatments, or are you unable to have them?
- Are you able to attend regular hospital appointments?
What does participation involve?
If you decide to take part, you'll receive the study drug, AVA6000, directly into your bloodstream through a drip. This will happen on either Day 1 of every 21-day cycle, or Day 1 of every 14-day cycle, depending on the study plan. You'll have regular hospital visits for blood tests, scans, and check-ups to monitor your health and how you're responding to the treatment. The total duration of your participation will depend on how you respond to the treatment and the study phase you are in, but you will be monitored closely throughout.
Potential risks and benefits
Locations (9)
- Memorial Sloan Kettering Cancer CenterVerified postcodeNew York, United States· Recruiting
- University of Texas MD Anderson Cancer CenterVerified postcodeHouston, United States· Recruiting
- Fred Hutchinson Cancer CenterVerified postcodeSeattle, United States· Recruiting
- The Beatson West of Scotland Cancer Centre, NHS Greater Glasgow & ClydeVerified postcodeGlasgow, United Kingdom· Recruiting
- St James's University Hospital, The Leeds Teaching Hospitals NHS TrustVerified postcodeLeeds, United Kingdom· Recruiting
- The Royal Marsden, NHS Foundation TrustVerified postcodeLondon, United Kingdom· Recruiting
- The Christie NHS Foundation TrustVerified postcodeManchester, United Kingdom· Recruiting
- The Freeman Hospital, Newcastle-upon-Tyne NHS Foundation TrustVerified postcodeNewcastle upon Tyne, United Kingdom· Recruiting
- Weston Park Cancer Centre, Sheffield Teaching Hospitals NHS Foundation TrustVerified postcodeSheffield, United Kingdom· Not yet recruiting
Common questions
What is AVA6000?
AVA6000 is a new drug being tested for advanced cancers that might have a specific feature called FAP.
What kind of cancers is this study for?
It's for specific advanced solid tumours including salivary gland, bladder, ovarian, breast cancer, and a type of soft tissue cancer.
Why is this called a 'first-in-human' study?
This means it's one of the first times this new drug is being given to people, so researchers are carefully checking its safety and effects.
Will I know if the drug is working?
The study team will regularly perform tests and scans to monitor your health and see how your cancer is responding to the treatment.
Can I stop participating if I want to?
Yes, you can choose to leave the study at any time, and this will not affect your ongoing medical care.
How to find out more
Avacta Life Sciences
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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