AuthorisedHuman Pharmacology (Phase I)- First administration to humansInterventional

A Study of GEN1106 in Participants with Solid Tumors

This research study is testing a new drug called GEN1106 in people who have solid tumours that are advanced or have spread around the body. This is a very early-stage trial, meaning it's the first time this medicine is being used in humans. Doctors want to carefully observe how the drug works in the body and check for any side effects. The main goal is to find out if GEN1106 is safe for people and what dose might be best for future studies. All adults aged 18 and over, regardless of gender, who have advanced or metastatic solid tumours may be able to take part. It's an important step in developing new cancer treatments.

At a glance

Status

Authorised

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Genmab A/S

Enrolment target

Start

27 Apr 2026

Metastatic or advanced malignant solid tumors

What is this study about?

This study is about a new investigational medicine, which means it's not yet approved for general use, called GEN1106. The doctors want to learn more about this medicine and how it affects people who have specific types of cancer. Specifically, they're looking at solid tumours that are either very advanced or have spread to other parts of the body (this is called metastatic cancer).

This is a 'Phase I' study, which is the very first step in testing a new drug in humans. The main aim at this stage isn't to cure cancer, but to safely find out if the new medicine, GEN1106, can be given to people, what dose is safe, and if it causes any side effects. Think of it like taking the very first cautious steps with a new medicine – observing carefully and gathering information.

The information gathered from this study will help researchers decide if GEN1106 is promising enough to continue testing in larger studies. If it proves to be safe and shows some encouraging signs, it could potentially become a new treatment option for cancer in the future. Every new medicine goes through this careful testing process to ensure it's both safe and potentially effective.

Key takeaways

Tests a new medicine, GEN1106, for advanced solid cancers.
First time GEN1106 is being given to people (Phase I study).
Main goal is to check safety and find the best dose.
Open to adults aged 18 and over, both men and women.
Participation involves regular visits and close health monitoring.
You can stop participating at any time.

Who may be eligible?

To join this study, you need to be an adult, aged 18 or older. There's no upper age limit, so people of all adult ages can be considered. Both men and women are welcome to take part in this research.

The study is specifically looking for people who have solid tumours. This means cancers that form a lump or growth, like breast cancer or lung cancer, rather than blood cancers. Your cancer needs to be advanced or have spread to other parts of your body. This is sometimes called 'metastatic cancer'.

There will be other specific health requirements and tests you'll need to meet to ensure your safety and suitability for the study. These will be discussed in detail by the study team, but generally, they'll check your overall health and how your body is coping with your cancer.

Quick self-check

Are you 18 years old or older?
Do you have a solid tumour (a cancer that forms a lump or growth)?
Is your cancer advanced or has it spread to other parts of your body?
Are you able to attend regular appointments for the study?

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 first have screening appointments to check if you are suitable. If you are, you would then receive the study medication, GEN1106, which will be carefully administered by the study team. You would need to attend regular clinic visits for checks, blood tests, and to discuss any side effects you might be experiencing. The frequency of these visits and tests might change over time, being more frequent at the beginning of the study.

The study team would monitor your health very closely throughout your participation. They would assess how your body is reacting to the medicine and if your cancer is responding. The total length of time you would be involved in the study could vary, but it would involve regular follow-up for a period after you stop taking the study drug. All these details, including the total duration and specific schedule of visits and tests, would be explained to you thoroughly before you make any decisions.

Potential risks and benefits

There's always a chance that taking part in a clinical trial could lead to new side effects from the investigational medication. The study team will closely monitor you for any problems and explain all known or potential risks. While there's no guarantee of a direct benefit, you might receive careful medical attention and access to a new treatment before it's widely available. Your participation could also help others by providing important information about future cancer treatments. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

—
Spain

Common questions

What is GEN1106?

GEN1106 is a new, experimental medication being studied for people with advanced cancers. It's not yet approved for general use.

What kind of cancer is this study for?

This study is for adults with solid tumours that are advanced or have spread to other parts of the body.

Is this a new treatment that will cure my cancer?

This is a very early-stage trial (Phase I). The main goal is to check for safety and find the right dose, not to cure cancer at this stage.

How long would I be in the study?

The total length of time you would be in the study varies, but it involves regular visits and follow-up after stopping the study drug. The study team will explain the specific duration if you qualify.

Can I leave the study if I change my mind?

Yes, you are free to leave the study at any time, for any reason, without it affecting your medical care.