Ongoing, recruitingPhase I and Phase II (Integrated)- First administration to humansInterventional

First-in-human, open-label, dose-escalation trial with expansion cohorts to evaluate safety of GEN1047 in subjects with malignant solid tumors

This study is a first-time test of a new medicine called GEN1047 in women who have different types of cancer. The main goals are to check if the medicine is safe and to find the best dose. We'll be carefully watching for any side effects and how the body handles the medicine. We also want to see if GEN1047 can make tumours smaller or stop them from growing. This is an early-stage study, meaning it's one of the first times this medicine is being given to people. It's a key step to understand if GEN1047 could become a useful treatment in the future.

At a glance

Status

Ongoing, recruiting

Phase

Phase I and Phase II (Integrated)- First administration to humans

Sponsor

Genmab A/S

Enrolment target

268

Start

22 May 2024

Malignant Solid Tumors

What is this study about?

This study is looking at a new medicine called GEN1047. It's designed for women who have different types of cancer that have spread in their bodies (malignant solid tumours). This is one of the very first times this medicine is being given to people, so it's a very early-stage trial. The main purpose is to carefully check if the medicine is safe and to find out the best dose to give.

The study is divided into two main parts. In the first part, called 'Dose Escalation', a small number of participants will receive increasing doses of GEN1047. Doctors will watch very closely for any side effects to figure out a safe and effective dose. In the second part, called 'Dose Expansion', more participants will receive the chosen dose, and doctors will continue to monitor safety and also see how well the medicine works against the cancer.

We'll be looking to see if the medicine can make tumours shrink, how long this effect might last, and if it helps people live longer or stops their cancer from getting worse. We will also be tracking how the body absorbs and processes the medicine, and if the body develops any reactions to it. This research is incredibly important because it helps us understand if GEN1047 could potentially become a new treatment option for cancer in the future.

Key takeaways

This is a first-time-in-humans study of a new cancer medicine, GEN1047.
It's for women aged 18 and over with specific types of solid tumours.
The main goals are to check safety, find the best dose, and see if it fights cancer.
You'll have regular medical checks and scans if you join.
You can stop participating at any point you wish.

Who may be eligible?

This study is specifically for women who are 18 years old or older. There is no upper age limit, meaning older women can also take part.

Participants must have a type of cancer that has formed a solid mass (a "solid tumour") and is considered "malignant," which means it has the potential to spread. Detailed medical checks will be done to make sure you fit all the necessary health requirements.

Important note: While this summary gives you a general idea, your doctor will need to review your full medical history and current health to determine if this study is right for you. There will be other specific rules about your type of cancer, previous treatments, and overall health that aren't listed here.

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?
Are you a woman?
Have you been diagnosed with a solid cancer that has grown or spread?
Are you able to travel to the study clinic for regular appointments?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll receive the study medicine, GEN1047, according to a set schedule. This is an "open-label" study, which means both you and your study doctor will know you are receiving GEN1047. This is not a placebo-controlled trial, so you will be receiving the active drug.

You will have regular hospital visits for blood tests, physical examinations, and scans to check your tumour size and overall health. These visits are very important for the study team to keep a close eye on how you are responding to the medicine and if you have any side effects. The total duration of your participation will depend on how you respond to the treatment and what the study doctors decide is best for your care, but it will involve ongoing assessments and follow-up.

Potential risks and benefits

Taking part in a study like this might offer potential benefits, such as access to a new medicine that isn't widely available yet, which could help with your cancer when other treatments haven't worked. However, there are also risks, as any new medicine can have side effects, some of which might be serious or unexpected. The study team will monitor you very closely for any bad reactions. It's important to remember that you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (7)

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

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Unverified
Denmark
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Unverified
Belgium
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Unverified
Netherlands
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Unverified
Spain
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Unverified
France
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Unverified
Poland
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Unverified
Italy

Common questions

What is GEN1047?

GEN1047 is a new experimental medicine being tested for the first time in people as a potential cancer treatment.

Who can join this study?

This study is for women aged 18 or older who have certain types of solid tumours.

Will I know if I'm getting the real medicine?

Yes, this is an 'open-label' study, so you and your doctor will know you are receiving GEN1047.

What are doctors looking for in this study?

Doctors are mainly looking to see if GEN1047 is safe, to find the right dose, and if it can shrink tumours.

What happens if I want to stop participating?

You can leave the study at any time, and your decision won't affect your medical care.