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

Study of safety and antitumor activity of GEN1056 in participants with advanced solid tumors

This research study is looking at a new treatment called GEN1056 for adults who have advanced solid tumours. A solid tumour is a lump of abnormal cells, and advanced means the cancer has spread from where it started. This is the very first time GEN1056 is being given to people, so the main aims are to check if it's safe and to see if it has any effect on the cancer. Researchers want to find out the best dose and how the body handles the medicine. If you're 18 or older and have an advanced solid tumour, this study might be an option. It's an early-stage study, meaning we're still learning a lot about this new treatment.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Genmab A/S

Enrolment target

Start

02 Oct 2024

Advanced solid tumors

What is this study about?

This study is a very early step in checking a new medicine called GEN1056, designed to treat certain cancers. When we say 'advanced solid tumours,' we mean cancers that form a solid lump and have either grown locally or spread to other parts of the body. Because this is the first time GEN1056 is being tested in humans, it's called a 'Phase I' study. The main goals are to find out if the treatment is safe, what side effects it might cause, and to work out the best dose.

The researchers will also be watching carefully to see if GEN1056 has any positive effects on the cancer itself. It's important to understand that new treatments often go through many stages of testing over several years. This study is crucial for gathering basic information that will decide if GEN1056 can move forward to larger studies.

Taking part in this kind of study helps scientists learn more about new ways to fight cancer, which could eventually benefit many people in the future. Even if a participant doesn't directly benefit, the information gained is valuable for medical research.

Key takeaways

This study is testing a brand-new cancer medicine called GEN1056.
It's for adults (18+) with advanced solid tumours.
The main goals are to check how safe it is and if it has any effect on the cancer.
It's an early-stage 'Phase I' study, so results will help guide future research.
Your participation helps advance cancer research, potentially helping others in the future.

Who may be eligible?

To join this study, you must be at least 18 years old. Both men and women can take part.

You would need to have an advanced solid tumour. This means your cancer has spread beyond where it started or grown within the body and is not responding well to standard treatments. The study team will check your medical details carefully to make sure the study is right for you and that taking part would be safe.

There will be other health requirements that the study team will discuss with you. These are in place to ensure your safety throughout the study and to make sure the results collected are accurate.

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 a diagnosis of an advanced solid tumour?
Are you able to attend regular clinic appointments?
Have you discussed this study with your cancer doctor (oncologist)?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive the new medicine, GEN1056. This is usually given regularly, and the way it's given (e.g., as a drip or a tablet) would be explained. You would need to attend the clinic regularly for check-ups, which include physical exams, blood tests, and scans to see how you are responding and to check for any side effects.

The study visits might be quite frequent at first, and then become less often over time. This helps the doctors monitor your health closely. The total length of your participation would depend on how you respond to the treatment and what the study doctors think is best for you. There would also be a follow-up period after you stop taking the medicine to continue monitoring your health.

Potential risks and benefits

While we hope new treatments can help, there's no guarantee that GEN1056 will directly benefit you. However, the information gained might help future patients. Like all medicines, GEN1056 may have side effects, some of which could be serious. Because this is a new medicine, not all side effects are known yet. The study team will explain all known potential risks to you. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Spain

Common questions

What is a 'solid tumour'?

A solid tumour is a lump or mass of abnormal cells that forms in your body, different from blood cancers like leukaemia.

What does 'advanced' cancer mean?

Advanced means the cancer has spread from where it started to other parts of your body, or it has grown locally and not responded to other treatments.

What is a 'Phase I' study?

A Phase I study is the first time a new medicine is given to humans. The main goal is to check its safety, side effects, and to find the right dose.

Will this medicine cure my cancer?

It's too early to say if GEN1056 will cure cancer. This study is primarily focused on safety and finding the best dose, although doctors will also look for signs that it's helping fight the cancer.

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 future medical care.