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

INCA 32459-101: A Phase 1, Open-Label, Multicenter Study of INCA32459 in Participants With Select Advanced Malignancies

This study, called INCA 32459-101, is looking into a new treatment called INCA32459. It's for people who have certain advanced cancers, such as melanoma (a type of skin cancer), head and neck cancer, or large B-cell lymphoma (a type of blood cancer). This is a very early stage of research, often called Phase 1. This means it's one of the first times this medicine is being given to people. The main goal is to understand if the new medicine is safe and how the body handles it. Doctors will also start to look for any signs that it might be working against the cancer. This 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

140

Start

17 Feb 2023

Metastatic melanoma Neoplasm malignant Squamous cell carcinoma of head and neck Diffuse large B-cell lymphoma Primary mediastinal large B-cell lymphoma

What is this study about?

This research study, known as INCA 32459-101, is designed to test a new medication called INCA32459. The study is for people who have certain types of advanced cancer that have spread in the body. These include melanoma (a serious form of skin cancer), squamous cell carcinoma of the head and neck, and specific types of lymphoma, which are cancers affecting certain white blood cells.

This is a 'Phase 1' study. Think of it as the very first step in testing a new medicine in people. Until now, this medicine would have only been tested in laboratories. The main aims at this early stage are to find out if the medicine is safe, what side effects it might cause, and how much of it the body can handle. Researchers also want to see how the body processes the medicine and if there are any early hints that it could help fight the cancer.

The information gathered from this study is really important. It helps doctors understand if the medicine has potential and if it's safe enough to be tested further in larger studies. The ultimate goal of such research is to find more effective and safer treatments for cancer patients in the future.

Key takeaways

Tests a new medicine (INCA32459) for advanced cancers.
This is a Phase 1 study, focused on safety and how the body uses the medicine.
Open to adults aged 18 and above, both men and women.
Specific cancers include melanoma, head/neck cancer, and certain lymphomas.
Participation involves regular clinic visits for monitoring.
You can withdraw from the study at any time.

Who may be eligible?

To be considered for this study, you must be at least 18 years old. There is no upper age limit, meaning older adults are also welcome to participate.

This study is for both men and women. Your doctor will need to check if you have one of the specific types of advanced cancer mentioned, such as metastatic melanoma (melanoma that has spread), certain head and neck cancers, or particular forms of large B-cell lymphoma.

There might be other health requirements too, which your study doctor will discuss with you. These are put in place to ensure that the study is as safe as possible for you and that the results from the study are clear and reliable.

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 metastatic melanoma, or a specific advanced head and neck cancer?
Do you have diffuse large B-cell lymphoma or primary mediastinal large B-cell lymphoma?
Are you able to travel to the study clinic for regular appointments?
Are you willing to follow the study procedures, including regular tests and check-ups?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you would be given the new medicine, INCA32459. This is an 'open-label' study, which means both you and your study doctor will know that you are receiving the active study medicine. You will need to attend regular appointments at the study clinic. During these visits, the medical team will carry out health checks, blood tests, and scans to monitor your health, see how the medicine is affecting your body, and look for any changes in your cancer.

The total amount of time you would be in the study can vary. You would continue to receive the medicine as long as your health allows and the medical team believes it is beneficial and safe for you. Even after you stop taking the study medicine, you will have follow-up visits or calls to check on your long-term health and any lasting effects.

Potential risks and benefits

Participating in an early-stage study like this means you might be among the first people to receive a new medication. While there's no guarantee the medicine will help your specific condition, potential benefits could include improvements in your cancer or its symptoms. However, as this is a new medicine, there might be unknown side effects, and some known side effects could be unpleasant or serious. Your medical team will carefully monitor you for any problems. You can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (4)

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

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Unverified
Belgium
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Unverified
Spain
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Unverified
Italy
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Unverified
France

Common questions

What does 'Phase 1' mean?

Phase 1 means this is one of the first times this new medicine is being given to people. The main goals are to check if it's safe and how the body handles it.

What kind of cancers is this study for?

This study is for specific advanced cancers, including certain types of melanoma (skin cancer), head and neck cancer, and lymphomas (blood cancers like diffuse large B-cell lymphoma).

Will I know if I'm getting the new medicine?

Yes, in this 'open-label' study, you and your study doctor will both know that you are receiving the new study medicine, INCA32459.

What happens if I decide to stop the study?

You are free to leave the study at any time, for any reason. Your decision will not affect your future medical care.

Who is running this study?

This study is sponsored by a company developing the new medicine, indicated by 'INCA' in the study name, and is being carried out in multiple medical centres.