A Phase 1, Dose-escalation Study of [225Ac]-FPI-2068 in Adult Patients With Advanced Solid Tumours
This study is looking into a new treatment for adults with advanced cancers such as bowel, head and neck, lung, pancreatic, stomach, or kidney cancer. These are cancers that have spread or come back, and haven't gotten better with usual treatments. The main goal is to find out if the new medicine, called [225Ac]-FPI-2068, is safe and how well people can tolerate it. Researchers will also check how the body handles the medicine and where it goes. This will help them find the best dose to use in the future. It’s an early-stage study, meaning it’s one of the first times this medicine is being given to people.
At a glance
What is this study about?
This study is exploring a new treatment called [225Ac]-FPI-2068 for people living with advanced cancer. This includes various types like advanced bowel, head and neck, non-small cell lung, pancreatic, stomach, and kidney cancers. These are cancers that have either spread to other parts of the body, come back after treatment, or cannot be removed by surgery.
The main purpose of this early-stage study is to carefully examine the new medicine. Researchers want to understand if it's safe to use, how well people can cope with the treatment (its 'tolerability'), and how it moves through and leaves the body. They will also look at how much of the medicine reaches the cancer cells and other body parts, which is important for finding the most effective dose.
This study is divided into two main parts. In the first part, researchers will work out the best dose of a supporting medicine called FPI-2053, which is given alongside the main treatment. Once they've found the ideal dose for FPI-2053, they will move to the second part. Here, they will gradually increase the dose of the main study medicine, [225Ac]-FPI-2068, to find the safest and most promising dose for future, larger studies.
Key takeaways
- Targets advanced solid cancers, including bowel, lung, and pancreatic types.
- Investigating a new, early-stage treatment called [225Ac]-FPI-2068.
- Main goals are to assess safety, tolerability, and find the best dose.
- Involves detailed monitoring, including blood tests and special scans.
- Participation is voluntary, and you can withdraw at any time.
Who may be eligible?
To be considered for this study, you would typically need to have a solid tumour that has been confirmed by a doctor. This cancer should be advanced, meaning it has spread, come back, or cannot be operated on. It's also important that your cancer hasn't gotten better with standard treatments, or these treatments aren't suitable for you.
You would also need to be generally well enough to take part, meaning you can carry out most of your usual activities, and your body's main organs (like your kidneys and liver) are working properly. Doctors will also need to be able to measure your cancer to see how it responds to treatment.
Some reasons you might not be able to join include having received similar radioactive treatments before, or having had other cancer treatments too recently. You also can't have serious fluid build-up (like around your lungs or heart) that needs regular draining, or uncontrolled cancer that has spread to your brain, unless it's been successfully treated and is stable.
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.
- Do you have an advanced solid tumour that has been confirmed by a doctor?
- Has your cancer progressed despite previous treatments, or are standard treatments not suitable for you?
- Are you 18 years old or older?
- Are you generally well enough to do most of your daily activities?
- Have you not received similar radioactive treatments in the past?
- Do you not have fluid build-up that needs draining often, or uncontrolled cancer in your brain?
What does participation involve?
If you decide to take part in this study, you will have several visits to the hospital. These visits will involve various checks and tests, such as blood tests, scans, and physical exams, to monitor your health and how the treatment is affecting you. You will also receive one or more of the study medicines, which are given into a vein. Some parts of the study will involve special imaging to see how the medicine travels in your body. The study is designed to help researchers understand the new medicine over time, so you will have follow-up appointments after you receive the treatment to monitor your progress and well-being. The total length of your participation will depend on how you respond to the treatment and the study's design for your specific case.
Potential risks and benefits
Locations (15)
- Research SiteVerified postcodeIrvine, United States· Withdrawn
- Research SiteVerified postcodePalo Alto, United States· Recruiting
- Research SiteVerified postcodeSanta Monica, United States· Not yet recruiting
- Research SiteVerified postcodeChicago, United States· Recruiting
- Research SiteVerified postcodeBoston, United States· Recruiting
- Research SiteVerified postcodeSt Louis, United States· Withdrawn
- Research SiteVerified postcodeOmaha, United States· Recruiting
- Research SiteVerified postcodeCleveland, United States· Recruiting
- Research SiteVerified postcodePittsburgh, United States· Withdrawn
- Research SiteVerified postcodeHouston, United States· Recruiting
- Research SiteVerified postcodeSeattle, United States· Recruiting
- Research SiteVerified postcodeEdmonton, Canada· Not yet recruiting
Common questions
What kind of cancer is this study for?
This study is for adults with advanced solid cancers that have spread or come back, including types like bowel, head and neck, lung, pancreatic, stomach, and kidney cancer.
Is this a new medicine?
Yes, this is an early-stage study, meaning it's one of the first times this new medicine (called [225Ac]-FPI-2068) is being tested in people.
What is the main goal of the study?
The main goal is to find out if the new medicine is safe, how well people can tolerate it, and what the best dose is to use for future studies.
How long will I need to be in the study?
The exact length of time you'd be in the study depends on your individual response and the study's plan for you, but it involves multiple visits and follow-up checks.
Can I leave the study if I change my mind?
Yes, you can choose to leave the study at any time, and this will not affect your usual medical care.
How to find out more
AstraZeneca Clinical Study Information Center
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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