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Ongoing, recruitingHuman Pharmacology (Phase I)- First administration to humansInterventional

Study of Recombinant Adenovirus AdVince in Patients With Neuroendocrine Neoplasms; Safety and Efficacy (RADNET)

This study is looking into a new treatment called AdVince for people with neuroendocrine neoplasms, often simply called NENs. These are a varied group of cancers that can occur in different parts of the body, like the stomach, intestines, pancreas, or lungs. Many people are diagnosed when their NENs have spread, making them harder to treat effectively. Currently, surgery is the only way to cure NENs if they haven't spread. AdVince is a new type of treatment, and this study is its first trial in humans. The main goal is to check how safe it is and if there are any serious side effects. Researchers will also be looking to see if it has any positive effects on the cancer, like shrinking tumors or stopping them from growing.

At a glance

What is this study about?

This study is investigating a new treatment called AdVince for people living with neuroendocrine neoplasms, often shortened to NENs. These are a unique group of cancers that can start in various organs throughout the body, most commonly in the digestive system (like the stomach, intestines, or pancreas) and the lungs. NENs can behave very differently from person to person, and sadly, many people are diagnosed when the cancer has already spread to other parts of the body. If the cancer has spread, there isn't currently a cure, although treatments can help manage it. When NENs are caught early and haven't spread, surgery to remove the tumor can be a cure.

Because finding new and effective treatments for NENs, especially when they have spread, is so important, researchers are testing AdVince. This study is an early phase, meaning it's the very first time this treatment is being given to people. The main purpose is to carefully check if AdVince is safe and to understand its possible side effects. Researchers will also be looking closely at whether the treatment has any impact on the cancer itself, such as reducing the size of tumors or slowing their growth. They will measure various things, including how the treatment affects your body and potential changes in your tumors over time.

By taking part in this study, you would be helping doctors learn more about AdVince and whether it could become a future treatment option for NENs. This vital research contributes to advancing our understanding and improving care for patients with this type of cancer.

Key takeaways

  • This study is testing a new treatment called AdVince for neuroendocrine neoplasms (NENs).
  • It's the first time AdVince is being given to people, so safety is the main focus.
  • Researchers will also look for signs that the treatment is affecting the cancer.
  • Participation involves receiving the drug and having regular check-ups and scans.
  • You would be contributing to important research for future NENs patients.

Who may be eligible?

To be considered for this study, you must be at least 18 years old. There is no upper age limit, and both men and women can take part.

You would need to have been diagnosed with neuroendocrine neoplasms (NENs) that doctors believe could potentially benefit from a new treatment approach.

Beyond these general points, there will be specific health checks and criteria that doctors will review to ensure the study is suitable and safe for you. This will involve looking at your overall health, the details of your cancer, and any other medical conditions you might have.

Quick self-check
  • Are you 18 years old or older?
  • Have you been diagnosed with neuroendocrine neoplasms (NENs)?
  • Are you willing to potentially receive a new, experimental treatment?
  • Are you able to attend regular appointments and tests?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to join this study, you would receive the new treatment called AdVince. This is a "first-in-human" study, which means it's the initial time doctors are giving this drug to people. The team will carefully monitor you throughout the study.

Participation usually involves several clinic visits where you will receive the AdVince treatment. At these visits, you'll have various tests, such as blood tests, and doctors will ask you questions about how you are feeling. They will closely check for any side effects and how your body is responding to the treatment. You will also have scans like CT, PET, or MRI to see if the treatment is affecting the size or activity of your tumors. The exact number of visits, tests, and the total length of your participation will be explained in detail by the study team.

Potential risks and benefits

Because AdVince is a new treatment, the main benefit of taking part is that you would be contributing to valuable scientific research that could help future patients with NENs. While it's possible the treatment could help your cancer, there's no guarantee it will work for you, and it might not offer a direct medical benefit. As with any new medicine, there are potential risks, including side effects that are currently unknown or not fully understood. The study team will carefully monitor you for any adverse effects. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

  • Sweden

Common questions

What are Neuroendocrine Neoplasms (NENs)?

NENs are a group of unusual cancers that can start in various parts of the body, most commonly in the digestive system or lungs. They can behave differently depending on where they are and how far they've spread.

What is AdVince?

AdVince is the name of the new treatment being tested in this study. It's an experimental drug, meaning it's still being researched and is not yet available as a standard treatment.

Why is this study important?

This study is important because it's the very first time AdVince is being given to people. It's a crucial step in understanding if this new treatment is safe and if it could help patients with NENs in the future.

Will I definitely get better if I join this study?

No, there's no guarantee. This is a research study to understand a new treatment. While it's possible AdVince could help, it might not work for everyone, and it might not offer a direct medical benefit to you.

Can I stop participating in the study at any time?

Yes, you can choose to leave the study at any point, for any reason, without it affecting your regular 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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