A PHASE 1/1B, OPEN-LABEL, MULTICENTER, FIRST-IN-HUMAN DOSE ESCALATION AND DOSE EXPANSION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, AND ANTI-TUMOR ACTIVITY OF VVD-159642 AS A SINGLE AGENT AND IN COMBINATION IN PARTICIPANTS WITH ADVANCED SOLID TUMORS
This is an early-stage research study for people with advanced solid cancers, meaning their cancer has spread or can't be cured by standard treatments. The study aims to look at a new medicine called VVD-159642. Researchers want to understand if this new medicine is safe, what its side effects are, and how it affects the body. It will also help them determine the best dose to give. They are also keen to see if it shows any signs of shrinking tumours, both when given on its own and when combined with other treatments. This is the first time this medicine is being given to people, so information on its safety and how it works is very important.
At a glance
What is this study about?
This study is a very early step in testing a new medicine called VVD-159642. It's for people who have advanced solid tumours, which means their cancer has grown or spread and can't be treated effectively by the usual methods. The main goal at this stage is to learn as much as possible about how the new medicine works in the human body.
Researchers will be looking closely at how safe VVD-159642 is and what side effects it might cause. They also want to understand how the body uses and gets rid of the medicine. This helps them figure out the right amount of medicine to give. They'll also check if the medicine has any effect on the tumours. It will be tested both as a single treatment and in combination with other medicines.
Finding new ways to treat cancer is very important. Studies like this help scientists understand if a new medicine like VVD-159642 could eventually become a helpful treatment option for people with advanced solid tumours in the future. It’s a key step in the long process of developing new medicines.
Key takeaways
- Tests a new medicine (VVD-159642) for advanced solid cancers.
- Focuses on safety, side effects, and finding the right dose.
- Looks for early signs of anti-cancer activity, alone and with other treatments.
- This is an early-stage (Phase 1) study, the first time in humans.
- Open to adults aged 18 and over with advanced solid tumours.
Who may be eligible?
To join this study, you must be at least 18 years old. Both men and women can take part. The study is for people who have advanced solid tumours, which means their cancer has grown or spread and can't be treated with standard therapies.
There might be other health conditions or previous treatments that could mean you can't join. For example, if you have certain other illnesses, or if your cancer type isn't a good fit for this particular study, you might not be able to take part. All these details are checked carefully by the study doctors.
It's important to remember that participating in a clinical trial is a big decision. Your study doctor will discuss all the specific rules and requirements with you to make sure this study is right for your individual situation.
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 an advanced solid tumour (cancer that has grown or spread)?
- Are you willing to have regular hospital/clinic visits and tests?
- Are you prepared to try a new, experimental medicine?
What does participation involve?
If you decide to join this study, you would receive the new medicine, VVD-159642, either by itself or with other treatments. You would have regular visits to the hospital or clinic for various tests and check-ups. These might include blood tests, scans (like CT scans), and physical examinations to see how your body is reacting to the medicine and if your cancer is responding.
The study would involve regular appointments over a certain period, which your study team will explain in detail. You would also have follow-up visits after you stop taking the treatment, so doctors can continue to monitor your health and any lasting effects. The total length of your participation would depend on how your body responds to the treatment and the study plan, but it will be made clear to you before you start.
Potential risks and benefits
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Common questions
What kind of cancer is this study for?
This study is for people with 'advanced solid tumours', meaning cancers that have grown or spread and can't be treated effectively with usual methods.
What does a 'Phase 1' study mean?
Phase 1 means it's an early study, often the first time a new medicine is given to people. The main focus is on safety and finding the right dose.
Will this medicine cure my cancer?
This is an early study, so it's not known if the medicine will cure cancer. The main goal is to check safety and see if there are any positive effects on tumours.
Can I stop taking part if I change my mind?
Yes, you can leave the study at any time, for any reason, without it affecting your medical care.
How old do I need to be to join?
You need to be at least 18 years old to be considered for this study.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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