RecruitingPHASE1INTERVENTIONAL

Study of INCA036978 in Participants With Myeloproliferative Neoplasms

This research study is looking into a new medicine called INCA036978 for people who have specific blood disorders known as myeloproliferative neoplasms (MPNs). These conditions include Myelofibrosis (MF), Polycythemia Vera (PV), and Essential Thrombocythemia (ET). The main goals of the study are to understand if INCA036978 is safe for patients, how well it is tolerated, and to find the best dose to use. We will test INCA036978 on its own and also in combination with existing standard treatments for these conditions. This is an early-stage study, meaning we are carefully checking how the new drug affects the body.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

Incyte Corporation

Enrolment target

218

Start

11 May 2026

Estimated completion

24 May 2030

Myeloproliferative Neoplasms

What is this study about?

This study is focused on a new medicine, INCA036978, for people living with a group of blood conditions called myeloproliferative neoplasms, or MPNs. These conditions include Myelofibrosis (MF), Polycythemia Vera (PV), and Essential Thrombocythemia (ET). If you have one of these conditions, you might know that they involve your body making too many blood cells.

The main purpose of this research is to see if INCA036978 is safe and well-tolerated by patients. We also want to find the best dose of the medicine to use. Researchers will be looking at how the drug works when given by itself and also when given alongside other treatments that doctors commonly use for MPNs. This is an important step in developing new treatments that could help people with these conditions.

By taking part, you would be helping doctors and scientists learn more about INCA036978. This information could eventually lead to new or improved treatment options for people with MPNs in the future. Every medicine we use today started with studies like this one.

Key takeaways

This study is testing a new medicine, INCA036978, for MPN conditions.
The main goals are to check safety, find the best dose, and see how it works alone or with other treatments.
It's an early-stage (Phase 1) study for adults 18 and over.
Participation involves regular clinic visits, tests, and possibly bone marrow biopsies.
There are potential benefits (new treatment, close monitoring) and risks (side effects, test discomfort).
You can discuss this study with your doctor and leave at any time.

Who may be eligible?

To join this study, you need to be at least 18 years old and have a myeloproliferative neoplasm (MPN) like Myelofibrosis (MF), Polycythemia Vera (PV), or Essential Thrombocythemia (ET). You should generally be in good health, apart from your MPN, and expected to live for more than six months. You also need to be willing to have some bone marrow tests (biopsies and aspirates) done before and during the study to help us understand how the treatment works.

There are certain reasons why someone might not be able to join. For example, if you have other blood cancers, or a different cancer that has appeared in the last three years, you wouldn't be eligible. People with serious heart problems, or active infections like HIV, Hepatitis B, Hepatitis C, or tuberculosis also cannot take part. If you've had a stem cell transplant before, or plan to have one soon, you also wouldn't be able to join.

We also can't include people who have recently had major bleeding or blood clots, or those who have been treated with certain MPN medicines or radiation therapy within a specific time before the study starts. Your doctors will check all your medical information and blood test results carefully against a detailed list to see if this study 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?
Have you been diagnosed with Myelofibrosis (MF), Polycythemia Vera (PV), or Essential Thrombocythemia (ET)?
Are you able to have regular blood tests and bone marrow samples taken?
Do you currently have a life expectancy of more than 6 months?
Have you had no other cancers in the last 3 years (except MPN)?
Have you NOT had a stem cell transplant recently or planning one soon?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be given the new medicine, INCA036978. It might be given on its own or together with another standard treatment for your MPN. The study involves regular visits to the hospital or clinic where you'll have various tests and check-ups. These typically include blood tests, physical examinations, and possibly some scans.

A key part of the study involves bone marrow biopsies and aspirates, which are tests where a small sample of your bone marrow is taken. You'll have these at the beginning of the study and at specific times while you're receiving treatment, to see how the medicine is affecting your condition. You will also have regular follow-up appointments after you finish taking the study medicine to monitor your health.

The total length of time you'll be involved in the study will depend on how you respond to the treatment and the specific part of the study you are in. Your study doctor and nurse will explain the schedule of visits, tests, and medication in detail before you make any decisions.

Potential risks and benefits

Taking part in this study could offer some potential benefits. You would receive a new investigational drug, INCA036978, and you would be closely monitored by a team of medical professionals. It's possible that this new treatment might help improve your condition, though this is not guaranteed, and we won't know for sure until the study is complete. You would also be contributing to important medical research that could help others with MPNs in the future. However, there are also potential risks involved. Like all medicines, INCA036978 may cause side effects, which could range from mild to serious, and some might not be known yet. The bone marrow tests can be uncomfortable and carry a small risk of bruising or infection. Your doctors and nurses will explain all known risks and closely monitor you for any problems. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (49)

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

University of Alabama At Birmingham
Verified postcode
Birmingham, United States· Not yet recruiting
City of Hope-Lennar Foundation Cancer Center
Verified postcode
Irvine, United States· Not yet recruiting
Usc Norris Comprehensive Cancer Center
Verified postcode
Los Angeles, United States· Not yet recruiting
UCLA Medical Hematology & Oncology
Verified postcode
Los Angeles, United States· Not yet recruiting
Yale Cancer Center
Verified postcode
New Haven, United States· Not yet recruiting
University of Miami
Verified postcode
Miami, United States· Not yet recruiting
Moffitt Cancer Center
Verified postcode
Tampa, United States· Not yet recruiting
Winship Cancer Institute of Emory University
Verified postcode
Atlanta, United States· Not yet recruiting
John Hopkins Hospital
Verified postcode
Baltimore, United States· Not yet recruiting
Massachusetts General Hospital
Verified postcode
Boston, United States· Not yet recruiting
Washington University School of Medicine
Verified postcode
St Louis, United States· Not yet recruiting
Mount Sinai School of Medicine
Verified postcode
New York, United States· Not yet recruiting

Common questions

What are Myeloproliferative Neoplasms (MPNs)?

MPNs are a group of uncommon blood conditions where your bone marrow makes too many blood cells. Examples include Myelofibrosis (MF), Polycythemia Vera (PV), and Essential Thrombocythemia (ET).

Is INCA036978 a new medicine?

Yes, INCA036978 is a new medicine that is still being tested. This study is one of the early steps to see if it is safe and how well it works.

What does 'Phase 1' study mean?

A Phase 1 study is usually the first time a new medicine is given to people. The main aim is to check its safety, how the body handles it, and to find the right dose, rather than how effective it is.

Will I get the new drug, or a dummy drug?

In this specific study, everyone who participates will receive the active study medicine, INCA036978. There isn't a dummy drug (placebo) involved in this trial design.

Can I stop participating in the study at any time?

Yes, if you decide to join, you are free to leave the study at any time and for any reason. Your decision will not affect your standard medical care.

How to find out more

Incyte Corporation Call Center (US)

medinfo@incyte.com 1.855.463.3463 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.