RecruitingPhase IInterventional

A study to test the safety of INCB160058 in participants with blood cancers

This study is looking at a new medicine called INCB160058 for people with certain blood cancers known as myeloproliferative neoplasms (MPNs). These conditions, like myelofibrosis, polycythemia vera, or essential thrombocythemia, cause the body to make too many blood cells. This new medicine aims to block a specific gene change (JAK2V617F) linked to these cancers, which can help control the overproduction of faulty blood cells. The main goals are to understand how INCB160058 works, find the safest and most effective dose, identify any side effects, and see if it helps treat these conditions. It will first be tested on its own and then in combination with an existing medicine, ruxolitinib, for a specific MPN. The study involves two parts: first, testing different doses, and then further checking its safety and effectiveness over approximately 12 months.

At a glance

Status

Recruiting

Phase

Phase I

Sponsor

Incyte (United States)

Enrolment target

193

Start

13 Feb 2026

Estimated completion

20 Jul 2027

Myeloproliferative neoplasms

What is this study about?

This study is looking into a new medication called INCB160058 for a group of blood cancers known as myeloproliferative neoplasms (MPNs). These cancers, which include conditions like myelofibrosis (MF), polycythemia vera (PV), and essential thrombocythemia (ET), mean your body's bone marrow makes too many blood cells – these could be red blood cells (which carry oxygen), white blood cells (which fight infection), or platelets (which help your blood clot). In many cases, these conditions are caused by a specific change in a gene called JAK2V617F, leading to the production of blood cells that don't work as they should. This can cause various health problems, such as tiredness due to anaemia, easy bleeding, or an increased risk of blood clots.

INCB160058 is a tablet designed to block this gene change, which researchers hope will help control the overproduction of abnormal blood cells. The study aims to answer several important questions: how the medicine works in your body, what the right dose is, if there are any unwanted side effects, and if it can effectively treat MPNs. The study will also look at how INCB160058 works when given together with ruxolitinib, another medicine already used to treat myelofibrosis that has the JAK2V617F gene change.

This is a 'Phase I' study, which means it's one of the first times this medicine is being tested in humans. Studies like this are crucial for understanding new treatments. They focus on finding a safe dose and looking for early signs of how well the medicine works, before it can be tested in larger groups of people. The study is split into two main parts: first, different doses of INCB160058 will be carefully tested to find a safe and effective amount, and then, in a second part, more patients will be given the chosen dose to gather more information on its safety and how well it works.

Key takeaways

The study tests a new medicine (INCB160058) for blood cancers like myelofibrosis, polycythemia vera, and essential thrombocythemia.
It aims to find a safe dose, check for side effects, and see if the medicine helps, sometimes with ruxolitinib.
You must have a specific gene change (JAK2V617F) to be eligible.
Participation involves regular visits, blood tests, possible scans, and bone marrow tests for about 12 months.
There are potential risks like side effects or discomfort from tests, but close monitoring will be provided.
You have the right to withdraw from the study at any time without affecting your usual care.

Who may be eligible?

To join this study, you need to be at least 18 years old and have one of the following blood cancers: myelofibrosis (MF), polycythemia vera (PV), or essential thrombocythemia (ET). These are all types of myeloproliferative neoplasms (MPNs).

It's also important that you have tested positive for a specific gene change called JAK2V617F, which is often linked to these conditions. If you have myelofibrosis and are joining the part of the study where you take INCB160058 on its own, you must have already tried at least one other JAK inhibitor medicine for at least 12 weeks, and it either didn't work well enough, your body didn't tolerate it, or it stopped working.

The study also has some health requirements that the study doctors will check, including your general health status and how long doctors expect you to live. There are also specific requirements about the size of your spleen for those with myelofibrosis. Before joining, you will need to agree to have bone marrow tests and follow certain rules to prevent pregnancy, if you or your partner could become pregnant.

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 myelofibrosis (MF), polycythemia vera (PV), or essential thrombocythemia (ET)?
Have you been tested and shown to have the JAK2V617F gene change?
If you have myelofibrosis and will take the study drug alone, have you already tried a JAK inhibitor medicine for at least 12 weeks and it didn't work well enough or caused problems?
Are you willing to have bone marrow tests and use birth control if needed?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you'll be involved for about 12 months. The study has two main parts. In the first part, called 'dose escalation,' different small groups of patients will receive increasing doses of the new medicine, INCB160058, to find the best dose that is both safe and has the best chance of working. In the second part, called 'dose expansion,' more patients will receive this chosen dose to get more information on how safe and effective it is.

You'll take the study medicine as a tablet by mouth. Throughout the study, you'll have regular hospital visits, including comprehensive physical exams at the start and end of the study, with shorter targeted exams in between if needed. You'll also have regular blood tests, including checks of your blood cell counts, and your vital signs (like blood pressure and pulse) will be monitored. You may also need scans, such as MRI or CT scans, to check your internal organs like your spleen and liver. You'll also need bone marrow tests both before the study and during it. For women who could become pregnant, regular pregnancy tests will be carried out.

To ensure your safety, you'll be monitored very closely for any side effects. If you're a man or woman who could have children, you'll need to use reliable contraception during and for a period after the study. The medical team will explain all the details of what is required at each visit.

Potential risks and benefits

There are no guaranteed benefits to taking part in this study, but we hope the new medicine, INCB160058, may help in treating your blood cancer. The main aim is to gather information that could help others in the future. As with any new medicine, there are potential risks and possible side effects. These could include things like low blood cell counts (leading to tiredness or easier bruising), nausea, or diarrhoea. There's also a chance of infections. The study team will closely monitor you for any changes and provide care if needed. Some procedures, like bone marrow exams or scans, also have small risks, such as discomfort, infection, or a minor allergic reaction to scan dyes. Your personal information will be kept private, but there's a small risk of data being accessed without permission. Taking part will also involve several visits, which can take up your time and require travel. You are free to withdraw from the study at any time without giving a reason, and your regular medical care will not be affected.

Locations (2)

Guys and St Thomas Hospital
City only
London, England
GenesisCare
Approximate
-, England

Common questions

What type of medicine is INCB160058?

It's a new medicine taken by mouth that aims to block a specific gene change (JAK2V617F) linked to certain blood cancers.

What are 'myeloproliferative neoplasms'?

These are blood cancers where your body makes too many blood cells. Examples include myelofibrosis, polycythemia vera, and essential thrombocythemia.

How long will I be in the study if I join?

You will be involved for approximately 12 months.

Will I have to do anything to prevent pregnancy?

Yes, if you or your partner could become pregnant, you will need to use reliable contraception during and after the study.

Can I leave the study at any time?

Yes, you can leave the study at any point without needing to give a reason, and it won't affect your ongoing medical care.

How to find out more

Claire Harrison

Claire.Harrison18@nhs.net +44 (0)2071882739 Official trial record

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