AuthorisedHuman Pharmacology (Phase I)- OtherInterventional

A clinical trial to learn how liver function affects the blood levels of DAK539 in people with advanced cancer

This study is for people with advanced cancer who also have problems with their liver. We are investigating a new drug called DAK539. The main goal is to understand how well the liver processes DAK539, which changes how much of the drug is in the blood. Because the liver plays a big part in how the body handles medications, we need to see if liver issues affect drug levels. This information is really important for doctors to know so they can give the correct and safest amount of DAK539 to patients in the future. By joining, you'd be helping researchers learn more about how to use this drug effectively for people like you.

At a glance

Status

Authorised

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Novartis Pharma AG

Enrolment target

Start

09 Apr 2026

Advanced Malignancies and Hepatic Impairment

What is this study about?

This research study is about a new medicine called DAK539, which is being investigated for people with advanced cancer. When we talk about "advanced cancer," it generally means cancer that has grown or spread. This study focuses specifically on individuals who also have some form of liver problems.

The main aim of this study is to understand how the body handles DAK539, especially when someone has liver difficulties. The liver is a very important organ that helps to break down and remove medicines from the body. If the liver isn't working as well as it should, it might affect how much of the drug stays in your system. By studying this, researchers can learn how to give the right dose of DAK539 – one that is both effective against the cancer and safe for patients, particularly those with liver issues.

This type of study is called a 'Human Pharmacology (Phase I)' study. In simple terms, this means it's an early-stage study focusing on how the drug works in the body and its safety, rather than how well it treats the cancer itself. The information gathered will be crucial for developing DAK539 further and ensuring it can be used safely and effectively by future patients with advanced cancer and liver problems.

Key takeaways

This study is for adults with advanced cancer and liver problems.
It aims to understand how a new drug, DAK539, acts in the body.
The information helps doctors find the safest and best dose for patients.
Participation involves regular clinic visits, blood tests, and taking the study drug.
You can stop participating at any time.
This is an early-stage study, focused on drug safety and how it works in the body.

Who may be eligible?

To join this study, you need to be an adult, 18 years old or older. There is no upper age limit, so people of all adult ages can take part. This study is open to both men and women.

Key to eligibility is having advanced cancer. This means your cancer has either spread or is at a stage where standard treatments may not be fully effective. You also need to have some level of liver impairment, meaning your liver isn't working perfectly.

The research team will carry out several checks and tests to make sure that joining this study is suitable and safe for you. They will review your full medical history and current health status.

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 advanced cancer?
Do you have some form of liver problem or liver impairment?
Are you able to attend regular hospital or clinic appointments for tests?
Are you willing to take a new investigational drug?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be receiving the study drug, DAK539. The specific way you take the drug (e.g., as a pill or injection) and how often will be explained in detail by the study team. You will have regular visits to the clinic for various assessments. These appointments will involve blood tests to measure the levels of DAK539 in your body and to check your general health, especially your liver function. There will also be physical examinations and scans to monitor your health and the cancer. The total duration of your participation in the study, including how long you take the drug and any follow-up appointments, will be clearly explained by the research team before you make any decisions.

Potential risks and benefits

Participating in this study might offer a chance to receive a new drug that isn't yet widely available for advanced cancer; however, it's important to remember that the main goal of this particular study is to understand the drug's behaviour, not primarily to treat your cancer. Like all medicines, DAK539 may have side effects, and the research team will explain these to you. There's also the chance that the drug might not help your cancer. You are completely free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

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

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Unverified
Spain
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Unverified
France
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Unverified
Italy

Common questions

What does 'advanced cancer' mean?

It generally means cancer that has grown, spread to other parts of the body, or is at a later stage.

What does 'liver impairment' mean?

It means your liver is not working perfectly, which can affect how your body handles medicines.

Will this drug cure my cancer?

This early-stage study focuses on how safe DAK539 is and how your body processes it, not primarily on curing cancer. We don't know yet if it will cure cancer.

How long will I be in the study?

The study team will tell you the exact duration based on your individual treatment plan.

Can I stop participating if I want to?

Yes, you can leave the study at any time, for any reason, without affecting your medical care.