A Phase 1/2, First-in-Human Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Anti_Tumor Activity of AVZO-021 as a Single Agent and in Combination Therapy in Patients with Advanced Solid Tumors.
This research study is for adults with advanced solid cancers. It's exploring a new medicine called AVZO-021. This is the very first time this drug is being given to people, so the main goals are to check if it's safe to use and to understand how the body reacts to it. Researchers will also be looking to see if it can help slow down or shrink the cancer. The study will test AVZO-021 on its own and also in combination with other treatments. It’s an early-stage study, meaning it’s a crucial step in learning about this potential new treatment.
At a glance
What is this study about?
Imagine your body as a complex machine. When it comes to cancer, sometimes certain parts of this machine stop working properly, leading to uncontrolled growth. Scientists are always looking for new ways to fix these problems or stop them from getting worse. This study is testing a brand-new medicine, called AVZO-021, which they hope might be one of these new solutions.
Because this is the very first time AVZO-021 is being given to people, the main aim is to be extra careful and learn as much as possible. Researchers will carefully check for any side effects and see how the drug moves through the body and how long it stays there. They'll also be looking closely to see if the drug shows any signs of fighting the cancer, both when given alone and when combined with other treatments.
This type of study is called a 'first-in-human' study and is a vital step in developing new treatments. It helps doctors understand if a new medicine is safe enough to be studied in more people and if it shows enough promise to potentially become a new treatment option in the future for people with advanced solid cancers.
Key takeaways
- This study is for adults with advanced solid cancers.
- It's testing a new drug, AVZO-021, for the first time in humans.
- The main goals are to check for safety and how the drug works in the body.
- It will test the drug alone and in combination with other treatments.
- Participation involves regular clinic visits for checks and tests.
- You can discuss this study with your doctor to see if it's right for you.
Who may be eligible?
This study is for adults aged 18 or older who have been diagnosed with advanced solid cancers. 'Advanced' means the cancer has spread or is difficult to treat with standard methods.
Specific medical conditions, past treatments, and overall health will be carefully reviewed by the study team. This is to make sure the study will be safe for you and that the results will be clear. The study team will need to make sure you meet all the necessary health requirements.
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 an advanced solid cancer?
- Are you able to attend all required clinic visits?
- Are you willing to follow all study procedures and instructions?
- Have you discussed this with your main cancer doctor?
What does participation involve?
If you decide to take part, you would receive the study drug, AVZO-021. You would have regular visits to the clinic for check-ups, blood tests, and scans to monitor your health and the cancer. These visits would be more frequent at the beginning of the study to closely watch for any side effects. You would also have regular discussions with the study doctors and nurses about how you are feeling. The exact number of visits, tests, and the total length of your participation would depend on how your body responds to the treatment and the phase of the study you are in. There would be follow-up appointments after you stop taking the study drug to monitor your long-term health.
Potential risks and benefits
Locations (5)
- —UnverifiedBelgium
- —UnverifiedSpain
- —UnverifiedItaly
- —UnverifiedGermany
- —UnverifiedFrance
Common questions
What does 'advanced solid tumors' mean?
It means cancers that have spread or grown significantly and cannot be treated by just surgery, and which started in solid organs like the breast, lung, or prostate, rather than blood cancers.
What is a 'Phase 1/2 study'?
It's an early-stage study that combines two phases. Phase 1 mainly checks the safety of a new drug and finds the right dose. Phase 2 then looks at how well the drug works against the cancer.
Will I know if I'm getting the drug or a dummy pill?
In this specific study, everyone enrolled will receive the active study drug (AVZO-021), either on its own or in combination with other treatments. There are no dummy pills involved.
What are 'pharmacokinetics' and 'pharmacodynamics'?
These are scientific terms. Pharmacokinetics means how your body handles the drug – how it absorbs it, where it goes, and how it gets rid of it. Pharmacodynamics means what the drug does to your body and the cancer.
Will I have to pay to be in the study?
No, you will not have to pay for the study drug or for the medical care directly related to your participation in the study.
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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