An Open-Label, Multicenter, Phase 1 Study Evaluating the Safety and Pharmacokinetics of ADU-1604 in Adults with Advanced Melanoma
This research study is looking at a new medicine called ADU-1604 for adults who have advanced melanoma, which is a serious form of skin cancer that has spread to other parts of the body. This is a "Phase 1" study, meaning it's the very first time this medicine is being tested in people. The main goals are to find out if the medicine is safe to use and to understand how the body processes it. This helps doctors learn the right dose and how often it should be given. It's an important step in developing new treatments for melanoma, focusing initially on safety before looking at how well it works.
At a glance
What is this study about?
This study is exploring a new potential medicine, called ADU-1604, for individuals battling advanced melanoma. Melanoma is a type of skin cancer that starts in the cells that make skin pigment. When it's advanced, it means the cancer has spread from where it started to other parts of the body. Finding new ways to treat advanced melanoma is really important, and studies like this help us get closer to better options.
This particular study is a "Phase 1" trial. What this means is that it's focusing on discovering how safe the new medicine is for people to take. It's the first time ADU-1604 has been given to humans, so the doctors will be very carefully watching participants for any side effects and how their bodies react to the treatment. They also want to understand how the medicine moves through the body, how it's absorbed, and how it's removed. This is often called 'pharmacokinetics'.
The information gathered from this study is crucial. It helps researchers decide if ADU-1604 is safe enough to study further in larger groups of people and helps them figure out the best dose. Think of it as the foundational step in developing a new medicine. If this early study shows promising results, it could eventually lead to new treatment options for people with advanced melanoma in the future.
Key takeaways
- This study is testing a brand-new medicine for advanced melanoma for the very first time in people.
- The main aim is to check if the medicine (ADU-1604) is safe and how your body processes it.
- Participation involves regular hospital visits, blood tests, and scans.
- You must be an adult with advanced melanoma to be considered.
- There are potential benefits (access to new treatment) and potential risks (unknown side effects).
- You have the right to stop participating at any time.
Who may be eligible?
To be considered for this study, you must be an adult, aged 18 years or older, with advanced melanoma. Advanced melanoma means your skin cancer has spread to other parts of your body.
Both men and women can take part in this study. The medical team will carefully review your health information to make sure the study is a good fit for you and that taking part would be safe.
There might be other health conditions or medicines that would prevent you from joining, as the main goal of this first study is to ensure safety with the new drug. The study doctors will go through all the detailed requirements with you.
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 advanced melanoma (meaning your cancer has spread)?
- Are you willing to attend regular hospital visits and undergo tests?
- Are you able to understand and sign an informed consent form?
What does participation involve?
If you decide to take part in this study, you would receive the new medicine, ADU-1604. You would have regular visits to the hospital or clinic so the study team can closely monitor your health. These visits will likely include physical examinations, blood tests, and possibly other tests like scans, to check how your body is responding to the medicine and to look for any side effects.
You would continue to receive the study medicine and attend follow-up appointments for a certain period, which the doctors will explain to you. The exact schedule of visits and tests will be detailed by the study team, and it's designed to ensure your safety and collect all necessary information about the new medicine. The duration of your participation will depend on how you respond to the treatment and the study plan.
Potential risks and benefits
Locations (4)
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Common questions
What is advanced melanoma?
Advanced melanoma is a serious type of skin cancer that has spread from where it started to other parts of your body.
What does 'Phase 1 study' mean?
It means this is the very first time this new medicine is being tested in humans. The main goal is to check how safe it is and how the body handles it.
Will this medicine cure my cancer?
It's too early to say if this medicine will cure cancer. Phase 1 studies aim to find out if the medicine is safe, not whether it cures the disease.
Will I get paid to join the study?
Clinical trials usually do not pay participants directly beyond covering travel costs or expenses related to study visits. This will be explained by the study team.
Can I leave the study if I change my mind?
Yes, you can leave the study at any time, for any reason. Your decision will not affect your ongoing medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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