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

A safety study of PF-08046045/SGN-35T in adults with advanced cancers

This study is testing a new medicine called PF-08046045/SGN-35T for adults who have advanced cancers, specifically different types of lymphoma, such as Hodgkin's disease and various B-cell and T-cell lymphomas. This is the very first time this new medicine is being given to people, so the main goal is to check how safe it is and how the body handles it. This type of early study helps researchers understand if a new treatment could potentially help patients in the future, by making sure it doesn't cause too many problems.

At a glance

What is this study about?

You might have heard about clinical trials, which are research studies that test new ways to prevent, detect, or treat diseases. This particular study is an early-stage clinical trial for a new medicine, which means it’s one of the first times this treatment is being given to people. The main purpose of this study is to find out if a new drug, known as PF-08046045/SGN-35T, is safe to use in humans and how it behaves in the body.

The study is for adults who have advanced cancers, specifically various types of lymphoma. Lymphoma is a type of cancer that starts in infection-fighting cells of the immune system, called lymphocytes. The study includes many different kinds of lymphoma, such as Hodgkin's lymphoma, several types of Non-Hodgkin’s lymphoma like B-cell lymphoma, T-cell lymphoma, and diffuse large B-cell lymphoma. Because it's an early study, researchers want to be very careful and learn as much as possible about this new medicine's effects.

Understanding how a new treatment works and if it's safe are important first steps before it can be studied in more people to see how well it treats the cancer. This study is crucial for gathering this basic but important information. If the results are positive, it could lead to further studies that might one day offer new treatment options for people living with these cancers.

Key takeaways

  • This study is for adults with advanced lymphomas.
  • It's a very early-stage trial testing a new medicine for the first time in people.
  • The main aim is to check the medicine's safety and how the body handles it.
  • There are potential benefits and risks, which will be fully explained.
  • You can withdraw from the study at any time if you choose.

Who may be eligible?

To be able to take part in this study, you would need to be an adult, aged 18 years or older. There is no upper age limit, meaning people of any adult age can be considered.

Participation is open to both men and women, as the study needs to understand how the new medicine affects everyone.

Ultimately, whether you can join the study will depend on your specific health situation and your type of cancer. The study is looking for people with advanced forms of certain lymphomas, such as Hodgkin's disease, B-cell lymphoma, and various T-cell lymphomas.

Quick self-check
  • Am I 18 years old or older?
  • Do I have an advanced form of lymphoma (like Hodgkin's, B-cell, or T-cell lymphoma)?
  • Am I open to receiving a new, experimental medicine?
  • Am I able to attend regular clinic visits and undergo medical tests?

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

What does participation involve?

If you decide to take part in this study, you would receive the new study medicine, PF-08046045/SGN-35T. As this is an early-stage study to check safety and how the body handles the medicine, there will likely be several visits to the clinic. These visits will involve various tests, such as blood samples, to monitor your health and how the medicine is working and affecting your body. You will also have regular check-ups with the study doctors and nurses.

The exact number of visits, tests, and the length of time you would be involved in the study would be explained in detail by the study team. This typically includes a period where you receive the treatment, followed by visits to check your progress and health after the treatment has finished. The study team will provide all the necessary information and support throughout your participation.

Potential risks and benefits

Taking part in any clinical trial involves both potential benefits and potential risks. A potential benefit of this study is that you might receive a new treatment that isn’t available outside of the trial, which could potentially help your condition. However, because this is a very early study, the main goal is to understand safety, and it's not guaranteed that the treatment will directly benefit your cancer. All medicines can have side effects, and some might be serious. The study team will explain all known and potential risks before you decide to join. Remember, taking part in a study is completely voluntary, and you have the right to withdraw at any time, for any reason, without affecting your usual care.

Locations (4)

  • Germany
  • Spain
  • Denmark
  • Italy

Common questions

What is the main goal of this study?

The main goal is to find out if the new medicine, PF-08046045/SGN-35T, is safe for people to take and how it works in the body.

What type of cancer is this study for?

This study is for adults with advanced forms of certain lymphomas, including Hodgkin's disease, B-cell lymphoma, and various T-cell lymphomas.

Is this a new medicine?

Yes, this is a new medicine, and this is the first time it's being given to people.

What does a 'Phase I' study mean?

Phase I means it's an early-stage study where researchers first test a new medicine in a small group of people to evaluate its safety and how the body handles it.

Can I leave the study if I change my mind?

Yes, you can leave the study at any time, for any reason, and it won't affect your future medical care.

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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