Study of INCA036978 for Myeloproliferative Neoplasms

This study is testing a new drug called INCA036978, both on its own and combined with standard treatments, for people with Myeloproliferative Neoplasms (MPN). MPN are a group of blood cancers that start in the bone marrow. The main goals are to find out how safe INCA036978 is, what side effects it might cause, and to determine the best dose. We are looking for 218 participants aged 18 and older who have Myelofibrosis (MF), Polycythemia Vera (PV), or Essential Thrombocythemia (ET). The study will track side effects for up to approximately 2 years. The current status of this study is unclear.

Study design
This is an interventional study with a planned enrollment of 218 participants. The phase of the study is not specified.
What's involved
You would need to be willing to have bone marrow biopsies before and during the study. The study will track side effects for up to approximately 2 years.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for treatment-emergent adverse events for up to approximately 2 years.

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NCT07441694

Study of INCA036978 in Participants With Myeloproliferative Neoplasms

Recruiting
PHASE1Ages 18+InterventionalTreatment
Incyte Corporation
~218 participants
Updated 2026-07-22 on ClinicalTrials.gov
What's tested:INCA036978Standard disease-directed therapy

At a glance

Recruiting sites
8 of 54 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with Dose Limiting Toxicities (DLT)s in Part 1
Measured over Up to 28 days
+2 more outcomes measured
Myeloproliferative Neoplasms
54 sites across 29 states
Germany5
Italy4
California3
New York3
North Carolina3
France3
Spain3
United Kingdom3
  • Incyte Medical Monitor · STUDY_DIRECTOR · Incyte Corporation
Incyte Corporation Call Center (US)
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Eligibility criteria

Inclusion

Life expectancy \> 6 months.
Willingness to undergo a pretreatment and limited on-study BM biopsies and aspirates (as appropriate to disease).
Participants with MF, PV and ET as defined in the protocol.

Exclusion

Presence of any hematological malignancy other than MF, PV, or ET.
Malignancy within the last 3 years prior to enrollment.
Acute or chronic HBV, Active HCV or known HIV or tuberculosis infection.
Clinically significant or uncontrolled cardiac disease.
Has undergone any prior allogeneic stem-cell transplantation or such transplantation is planned in the next 6 months.
Laboratory values outside the Protocol-defined ranges.
Prior history of major bleeding or thrombosis within the last 3 months prior to study enrollment.
Presence of chronic or current active infectious disease requiring systemic treatment.
Treatment with an MPN-directed therapy (approved or investigational) within the per protocol threshold before the administration of study drug.
Prior radiation therapy within 28 days before the first dose of study treatment.
  • Number of participants with Dose Limiting Toxicities (DLT)s in Part 1Up to 28 days

    Dose-limiting toxicity will be defined as the occurrence of any of the toxicities as per protocol.

  • Number of participants with Treatment-emergent Adverse Events (TEAEs)Up to approximately 2 years

    Defined as adverse events AE (either reported for the first time or the worsening of a pre-existing event) occurring after the first dose of study drug and up to 60 days after last dose of study drug or until the start of a new disease-directed therapy, whichever occurs first.

  • Number of participants with TEAEs leading to dose modification or discontinuationUp to approximately 2 years

    Number of participants with TEAEs leading to study drug modifications (interruptions, dose reduction) or discontinuation.