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

First-in-Human, Open-label, Dose-Escalation Trial with Expansion Cohorts to Evaluate the Safety of GEN1053 as Monotherapy and in Combination With an Immunomodulator in Subjects with Malignant Solid Tumors

This research study is for adults with different types of solid tumours that have grown or spread. It's an early-stage study, meaning it's the first time this new medicine, called HexaBody-CD27, is being tested in people. The main goals are to find out if the medicine is safe, what dose works best, and if it causes any unwanted side effects. Researchers will also look at how the body handles the medicine and if it shows signs of shrinking tumours, either on its own or when given with another type of medication. This is a crucial step in developing new treatments for cancer, as it helps us understand if a new medicine is promising enough to study further.

At a glance

Status

Ongoing, recruiting

Phase

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

Sponsor

Genmab B.V., Genmab B.V.

Enrolment target

Start

30 Jan 2023

Malignant Solid Tumors

What is this study about?

This clinical trial is designed to investigate a new treatment called HexaBody-CD27 for people who have solid tumours that have spread or are difficult to treat. Solid tumours are growths of abnormal cells found in various parts of the body, like the breast, lung, or bowel. This study is considered 'first-in-human', which means it's the very first time this particular medicine is being given to people. This is an important step in developing new medicines, as it allows doctors to carefully observe its effects.

The main purpose of the study is to understand how safe HexaBody-CD27 is and to find the right amount, or 'dose', that can be given without causing too many problems. Researchers will be monitoring participants very closely for any side effects, often called 'adverse events', and doing various tests to ensure their body is handling the medicine well. They will also look at how the body processes the medicine – for example, how quickly it leaves the body.

While safety is the top priority, the study will also look for early signs of whether the medicine is helping to fight the cancer. This includes checking if the tumours get smaller, stop growing, or if the and other measurements show the body responding positively to the treatment, both when given alone and in combination with another medicine. This information helps doctors decide if the new treatment has potential for further investigation in larger studies.

Key takeaways

This is an early study of a new cancer medicine called HexaBody-CD27.
It's for adults with solid tumours that have spread.
The main focus is to check safety and find the right dose.
Doctors will also look for early signs that the treatment might shrink tumours.
Participation involves regular hospital visits for treatment and monitoring.

Who may be eligible?

This study is open to adult patients aged 18 and over who have been diagnosed with a solid tumour. This means your cancer started in an organ or tissue, rather than in the blood or bone marrow.

To be considered for this study, your solid tumour must be 'malignant,' which means it is cancerous and has the potential to spread. Your doctor will be able to confirm if your specific type of cancer fits the criteria for this trial.

Both men and women are eligible to participate. There will be other specific medical requirements that your doctor will check to make sure the study is a safe and appropriate option for 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 a solid tumour?
Has your doctor told you your solid tumour is 'malignant' (cancerous)?
Are you able to attend regular hospital appointments for treatment and check-ups?

Answer every question to see your result.

What does participation involve?

If you decide to participate, you will receive the new medicine, HexaBody-CD27, either on its own or in combination with another medicine, through an intravenous (IV) drip. The study doctors will carefully increase the dose over time to find the safest and most effective amount. You will have regular visits to the hospital for examinations, blood tests, and other check-ups to monitor your health and how you are responding to the treatment. These visits will be more frequent at the start and then may become less often. The total length of your participation will depend on how you respond to the treatment and the study plan, but it's important to remember that this is an early-stage study, and the duration can vary for each person. There will also be a follow-up period after your treatment ends to continue monitoring your health.

Potential risks and benefits

Taking part in this study may offer some potential benefits, such as receiving a new and experimental treatment for your cancer that isn't available yet. However, there's no guarantee that the treatment will work for you, and it might not improve your condition. Research studies always carry potential risks. The new medicine could cause unexpected side effects that we don't fully know about yet. Study doctors will carefully monitor you for any problems. You have the right to withdraw from the study at any time, for any reason, without it affecting your 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 growth of abnormal cells that forms a mass, typically in an organ or tissue, as opposed to cancer that affects blood cells.

What does 'first-in-human' mean for this study?

It means this is the very first time this new medicine, HexaBody-CD27, is being tested in people. It's a crucial early step to see if it's safe and how it works.

Will I definitely get the new medicine?

Yes, if you join this study, you will receive the new medicine, HexaBody-CD27, either by itself or with another medicine. This is not a study where you might receive a placebo (dummy treatment).

How long will I be in the study?

The length of time you'll be in the study can vary. It depends on how you respond to the treatment and the study plan, but it will involve regular hospital visits and check-ups.

What if I want to stop taking part?

You are free to leave the study at any time, for any reason. Your decision will not affect your future medical care or relationship with your healthcare team.