Ongoing, recruitingHuman Pharmacology (Phase I)- First administration to humansInterventional

A Phase 1a/1b Study Exploring the Safety and Tolerability of INCB081776 in Participants With Advanced Malignancies

This research is looking at a new experimental medicine, INCB081776, for people who have advanced cancers. It's still very early days for this medicine, as this is the first time it will be given to humans. The main goal is to carefully check if the medicine is safe to use and what side effects it might cause. Doctors will also want to see how the body handles the medicine. Because it's a new medicine, there's a lot to learn, and this first study helps us understand if it can be explored further as a potential treatment in the future. The study is open to both men and women aged 18 and over.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Incyte Corp.

Enrolment target

Start

30 Aug 2024

Advanced malignancies.

What is this study about?

This study is an early-stage research project, often called a Phase 1 study, for a brand-new medicine named INCB081776. The main purpose of this kind of study is not to cure cancer, but to learn important information about the medicine itself. We need to find out if it's safe for people to take and what kinds of effects it has on the body, including any side effects.

Think of it like testing a new car for the first time. Before it can be driven on public roads, engineers need to make sure the brakes work, the steering is safe, and there are no unexpected problems. Similarly, this study is about checking the 'safety features' of INCB081776 in a controlled way, in a small group of people.

The information gathered from this study, such as safe doses and any side effects, will help doctors decide if and how to continue researching INCB081776. If it proves to be reasonably safe, it could then be tested in future studies to see if it helps treat advanced cancers more effectively than existing options.

Key takeaways

This study is testing a completely new cancer medicine (INCB081776) for the first time in people.
The main goal is to check for safety and side effects.
It's for adults (18 years and older) with advanced cancers.
Participation involves regular hospital visits for tests and monitoring.
You can stop taking part at any time.
It's a very early-stage study, so direct benefit to you is not guaranteed.

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. You would be considered if you have advanced cancer.

There will be other specific health checks and requirements that the study doctors will need to go through with you. These are in place to make sure the study is safe for you and that the results are clear. For example, they will check your general health, your specific type of cancer, and if you have had certain treatments before.

It's important to discuss your full medical history with the study team. They will explain exactly what conditions or previous treatments might mean you can or cannot take part.

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 advanced cancer?
Are you able to attend regular hospital appointments?
Have you discussed this study with your doctor?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will be given the new medicine, INCB081776. You will have regular visits to the hospital or clinic. These visits will involve various tests, such as blood tests, physical examinations, and possibly scans, to monitor your health and how your body is reacting to the medicine. The study doctors and nurses will explain how often these visits will be and for how long. You'll also be asked to report any side effects you experience.

The total duration of your involvement in the study will depend on how you respond to the medicine and what the study doctors determine is best for you. This will include the time you are taking the medicine and follow-up appointments after you stop.

Potential risks and benefits

Taking part in this study means you'll receive a new medicine that could potentially help with your condition, but it's important to remember this is an early-stage study, so it's not known if it will benefit you directly. There's also a chance you might experience side effects from the medicine, some of which could be serious, as its full range of effects is not yet known. The study team will monitor you closely for any issues, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual 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
Netherlands

Common questions

What kind of cancer is this study for?

This study is for people with advanced cancers. The study doctors will discuss if your specific cancer type fits the requirements.

How old do I need to be to join?

You need to be at least 18 years old to take part in this research study.

What is a 'Phase 1' study?

A Phase 1 study is the very first step in testing a new medicine in people. It's mainly to check if the medicine is safe and what side effects it might cause, rather than specifically how well it treats the disease.

Will I definitely get the new medicine?

Yes, if you join this study, you will receive the new experimental medicine, INCB081776.

Can I stop taking part if I change my mind?

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