Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A Phase I Study of INCB099280 in Combination With Ipilimumab in Participants With Selected Solid Tumors

This is an early research study, called a Phase I trial, looking into a new drug, INCB099280, when given alongside an established cancer medicine called YERVOY. The combination is being tested in people with various solid tumours. The main goal is to carefully check for any serious side effects or safety concerns caused by the new drug combination. Researchers will also observe how much of the new drug stays in the body and if it shows any early signs of helping to control the cancer. This kind of study helps doctors understand if a new treatment is safe enough to be tested in larger groups of people later on.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Incyte Corp.

Enrolment target

Start

19 Feb 2024

Solid tumor

What is this study about?

This study is an early-stage clinical trial, often called a Phase I study. In this type of research, doctors are mainly focused on understanding the safety of a new treatment. They want to find out if a new drug called INCB099280, when given with a current cancer medication called YERVOY (also known as ipilimumab), causes any serious side effects in people with solid tumours. Solid tumours are growths of abnormal cells in the body, such as those found in breast cancer, lung cancer, or colon cancer.

The main purpose of this study is not to cure cancer at this stage, but to carefully watch for any unwanted reactions or problems that might happen. The research team will be looking closely at any side effects, including those that might lead to a pause, a smaller dose, or stopping the treatment altogether.

They will also be checking how the new drug moves through the body and how long it stays there. While safety is the top priority, they will also be looking for any early signs that the treatment might be helping to control the cancer, such as by shrinking tumours or stopping them from growing. This information is crucial for deciding if the new drug combination should be tested further in larger studies.

Key takeaways

This is an early-stage (Phase I) study focusing on the safety of a new drug combination.
It's for people with various solid tumours.
They are testing a new drug (INCB099280) with an existing cancer medicine (YERVOY).
Close monitoring for side effects is the main priority.
Participation involves regular clinic visits for physical exams and tests.
It's important to understand the potential risks and benefits before deciding to join.

Who may be eligible?

To be able to take part in this study, you must be at least 18 years old. Both men and women can join.

Because this is an early-stage study for people with solid tumours, there will be other specific health requirements that your doctor will need to check. These will ensure the study is safe for you and that the results are clear.

Your general health, any other medical conditions you have, and any other medications you are taking will all be carefully reviewed by the study doctors to see if this trial 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 tumour?
Are you generally well enough to participate in a clinical study?
Are you able to attend regular clinic appointments and undergo medical tests?
Are you willing to potentially receive a new, experimental drug?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the new experimental drug INCB099280 along with YERVOY. You would have regular visits to the clinic, which would involve physical examinations, having your vital signs checked (like your pulse and blood pressure), and receiving electrocardiograms (ECGs) to check your heart. Blood samples would also be taken regularly to monitor your health and to check levels of the study drugs.

Throughout the study, the medical team will carefully monitor you for any side effects. If you experience any problems, the dose of the medication might be adjusted, or the treatment might be paused or stopped based on what the doctors think is best for your safety. The total duration of your participation would depend on how your body responds to the treatment and the study plan, but you would be kept fully informed.

Potential risks and benefits

As with any new treatment, there are potential risks involved. The main purpose of this early study is to identify these side effects, which could range from mild to serious. While there is no guarantee, you might experience some benefit if the treatment helps control your cancer, which would be a positive but secondary aim at this stage. You have the right 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
Sweden
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Unverified
Norway
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Unverified
Slovakia

Common questions

What is a 'Phase I' study?

It's the first stage of testing a new drug in people. The main goal is to check for safety and find the right dose, rather than expecting a cure.

What are 'solid tumours'?

Solid tumours are physical lumps or growths of cancer cells, found in organs like the breast, lung, or colon, unlike blood cancers.

What are the drugs being tested?

This study is testing a new drug called INCB099280 alongside an existing cancer medicine called YERVOY.

Will this study cure my cancer?

At this early stage, the study's main focus is on safety, not on curing cancer. Any benefits in controlling cancer would be a welcome secondary finding.

What kind of tests will I have?

You'll have physical checks, blood tests, heart readings (ECGs), and vital signs monitored regularly to check your health and for side effects.