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 and Preliminary Efficacy of GEN1078 in Subjects With Malignant Solid Tumors

This study is a very early investigation into a new drug, GEN1078, for people with various solid cancers. It's designed in two main parts. First, a small group of patients will slowly increase their dose of GEN1078 so doctors can find the safest and most effective amount to give. They'll be closely watching for any side effects. Once a good dose is found, more patients will receive it to see how well it works at shrinking tumors or keeping the cancer stable. The main goals are to check the drug's safety, understand how it moves through the body, and see its potential to help patients.

At a glance

Status

Ongoing, recruiting

Phase

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

Sponsor

Genmab A/S

Enrolment target

Start

20 Dec 2024

Malignant solid tumors

What is this study about?

This study is looking at a new treatment called GEN1078 for people who have solid cancers. Solid cancers are those that form a lump or growth, rather than cancers of the blood. Since this is an 'early stage' study, it means that GEN1078 hasn't been widely used in people before. The main purpose is to learn as much as possible about how the drug works in the human body. Think of it like taking a brand new car for its first test drives – the engineers want to check everything carefully before it goes on the road for everyone.

There are two main parts to this study: In the first part, a small number of participants will be given very small doses of GEN1078, which will then be slowly increased. This helps the doctors find the dose that is safe and tolerable, while also looking for any early signs that the drug might be helping. During this time, the medical team will pay close attention to any changes in your health, good or bad, to understand how your body reacts to the drug. They also want to understand how the drug is absorbed, used, and cleared from your body.

Once a safe and suitable dose is found, the study moves into its second part. Here, more participants will receive this chosen dose. The main goal of this part is to see how well GEN1078 works against different types of solid tumors. This includes checking if tumors get smaller, if their growth slows down, or if they stay stable. Importantly, throughout the entire study, the safety of the participants is the top priority, and researchers will constantly monitor for any side effects.

Key takeaways

This is an early-stage study for a new cancer drug, GEN1078.
It's for adults with various types of solid cancers.
The main goals are to check safety, find the best dose, and see if it helps against cancer.
Participation involves regular clinic visits, blood tests, and scans.
Risks and benefits will be fully explained, and you can withdraw at any time.

Who may be eligible?

To join this study, you must be at least 18 years old. The study is open to both men and women.

Participants in this study will have a type of cancer known as a solid tumor. This refers to cancers that form a mass or lump, rather than blood cancers such as leukaemia.

There will be other, more detailed requirements to join, based on your specific cancer type, your overall health, and any other treatments you may have had. A doctor involved in the study will review your medical history to see if this study is right 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?
Do you have a diagnosis of a solid tumor (a cancer that forms a lump)?
Are you able to attend regular clinic appointments for treatment and tests?
Are you willing to potentially try a new, unproven treatment?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive the new drug, GEN1078. The study will involve regular visits to the clinic for medical check-ups, blood tests, and scans to monitor your health and how the treatment is working. The frequency of these visits might be higher at the beginning of the study and then become less frequent over time.

During your visits, doctors and nurses will assess your general health, check for any side effects, and perform specific tests to see how the drug is affecting your cancer. These may include blood samples to understand how GEN1078 moves through your body and imaging scans (like CT scans) to measure specific tumors. You will also be asked about any symptoms you're experiencing.

While the total duration can vary for each participant, the study is designed to closely monitor you throughout the treatment period and for a follow-up period after stopping the drug to ensure your well-being. Your specific schedule will be explained in detail by the study team.

Potential risks and benefits

Participating in an early-stage study like this means you might be among the first people to receive a new treatment for your cancer. While this offers the potential for benefits if the drug proves effective, it's important to remember that the full effects and side effects of GEN1078 are not yet completely known. There's a chance the drug may not help your cancer, or it could cause side effects, some of which might be serious. Before joining, the study team will discuss all known and potential risks and benefits with you. You have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (2)

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
Spain

Common questions

What is a 'solid tumor'?

A solid tumor is a lump or growth of abnormal cells. It's different from blood cancers like leukaemia.

What does 'early-stage study' mean?

It means this is one of the first times this new drug, GEN1078, is being tested in humans. Researchers are focused on safety and finding the right dose.

Will I definitely get the new drug?

Yes, everyone in this study will receive the investigational drug, GEN1078. This study doesn't compare it to a dummy drug (placebo).

What kind of tests will I have?

You'll have regular health checks, blood tests, and scans (like CT scans) to measure your tumors and see how the drug is working.

Can I stop participating if I want to?

Yes, you can choose to leave the study at any time, for any reason. Your decision won't affect your ongoing medical care.