A First-in-Human Study of INCA035784 in Participants With Myeloproliferative Neoplasms
Myeloproliferative neoplasms (MPNs) are a group of rare conditions where the bone marrow produces too many blood cells. This clinical trial is testing an experimental medicine called INCA035784 for the very first time in humans. Because this is a Phase 1 study, the main goal is not yet to prove how well the medicine works, but to find out if it is safe. Doctors want to see what side effects it might cause, find the safest dose, and track how the body breaks it down. The trial is open to adults aged 18 and older diagnosed with an MPN. People who take part will have close medical supervision and regular tests. While early trials carry unknown risks, they are a vital first step in discovering new treatments for people living with rare blood conditions.
At a glance
What is this study about?
Myeloproliferative neoplasms, often shortened to MPNs, are a group of uncommon blood cancers. In a healthy body, the bone marrow makes the right balance of red blood cells, white blood cells, and platelets. In people with MPNs, the bone marrow makes too many of one or more of these cells. Over time, this can lead to symptoms like severe tiredness, bleeding, easy bruising, or an enlarged spleen, and it can increase the risk of blood clots.
This study is testing an experimental drug called INCA035784. It is known as a 'first-in-human' Phase 1 trial. This means the medicine has been carefully tested in laboratories, but this is the first time doctors are giving it to people. The primary purpose is to see how the human body reacts to the drug, measure any side effects, and work out the safest dose to use in future research.
Finding new treatments for MPNs is important because existing medicines do not work for everyone, and some treatments can stop working over time or cause difficult side effects. By testing new options like INCA035784, researchers hope to lay the groundwork for better, more targeted therapies in the future.
Key takeaways
- This is an early Phase 1 trial testing the new drug INCA035784 in humans for the first time.
- The study is for adults aged 18 and over with myeloproliferative neoplasms (MPNs).
- The main aim is to test safety, discover side effects, and find the best dose.
- Participants will be closely watched by medical experts through frequent hospital visits and tests.
- Joining is completely voluntary, and you can leave the study at any time.
Who may be eligible?
This trial is designed for adults aged 18 and over who have been diagnosed with a myeloproliferative neoplasm. Both men and women can take part.
Because this is an early-stage safety study, participants usually need to meet certain general health standards. This often includes having reasonably healthy kidney and liver function and being well enough to attend regular hospital appointments.
People with certain other serious health issues, active uncontrolled infections, or those who are pregnant or breastfeeding are usually unable to join. A hospital doctor or haematologist (blood specialist) will review your full medical history to see if the trial is suitable 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.
- I am 18 years of age or older.
- I have been diagnosed with a myeloproliferative neoplasm (MPN).
- I am well enough to attend regular hospital check-ups and blood tests.
- I am not currently pregnant or planning a pregnancy during the study.
- I am open to trying a new medicine that is being tested in humans for the first time.
What does participation involve?
Taking part usually involves visiting a specialist hospital clinic regularly. At the start, you will have a thorough screening visit, which may include physical examinations, blood tests, heart traces (ECGs), and checks on your general wellbeing.
Once accepted onto the study, you will be given the study drug INCA035784. You will need to attend frequent clinic visits, especially during the first few weeks, so doctors can monitor your blood counts and check how your body handles the medicine. You may also need to fill out symptom diaries.
The total time you spend on the trial can vary from several months to over a year, depending on how your body tolerates the treatment and whether your doctor feels it remains in your best interests.
Potential risks and benefits
Locations (3)
- —UnverifiedItaly
- —UnverifiedBelgium
- —UnverifiedGermany
Common questions
What does a 'first-in-human' study mean?
It means this is the very first time the experimental drug is being given to people, following laboratory safety tests, to check how safe it is.
Will this drug cure my blood condition?
Phase 1 trials are designed to test safety and dosage rather than provide a cure, so researchers cannot promise that your condition will improve.
Do I have to pay to take part?
No, clinical trial medicines and study-related tests are provided free of charge, and some trials help cover travel expenses to the clinic.
What happens if I experience unpleasant side effects?
The study team monitors you very closely. If you develop side effects, the doctors can treat them, lower your dose, or pause the trial drug if necessary.
Can I leave the trial if I change my mind?
Yes. You have the right to withdraw from the trial at any time, for any reason, and your regular medical team will continue supporting you.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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