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INCA036978 for people with myeloproliferative neoplasms

A Phase 1, Open-Label, Multicenter Study of INCA036978 in Participants With Myeloproliferative Neoplasms

PHASE1 · Incyte Corporation · NCT07441694

This Phase 1 study will test whether INCA036978, given alone or with standard therapy, is safe and tolerable for adults with myeloproliferative neoplasms such as myelofibrosis, polycythemia vera, and essential thrombocythemia.

Quick facts

PhasePHASE1
Study typeInterventional
Enrollment218 (estimated)
Ages18 Years and up
SexAll
SponsorIncyte Corporation (industry)
Drugs / interventionsradiation
Locations47 sites (Birmingham, Alabama and 46 other locations)
Trial IDNCT07441694 on ClinicalTrials.gov

What this trial studies

This is a Phase 1, dose-escalation trial designed to define safety, dose-limiting toxicities, and the maximum tolerated dose or recommended dose for expansion of INCA036978 when used alone or combined with standard disease-directed therapy. Participants will receive ascending doses of INCA036978 and will be monitored closely for adverse events, laboratory changes, and disease-specific markers. Pretreatment and limited on-study bone marrow biopsies and aspirates are required as appropriate for the specific MPN subtype. The study excludes patients with other recent malignancies, uncontrolled infections, significant cardiac disease, recent major bleeding or thrombosis, or recent allogeneic stem cell transplant.

Who should consider this trial

Good fit: Adults with a confirmed diagnosis of myelofibrosis, polycythemia vera, or essential thrombocythemia, a life expectancy over six months, acceptable laboratory values, and willingness to undergo baseline and on-study bone marrow procedures are the ideal candidates.

Not a fit: Patients with other recent cancers, active viral infections (HBV, HCV, HIV), tuberculosis, uncontrolled cardiac disease, recent major bleeding or thrombosis, prior or planned allogeneic stem-cell transplant, or who cannot meet washout/lab criteria are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, INCA036978 could become a new treatment option that improves symptoms or disease control for some patients with MPNs who need alternatives to current therapies.

How similar studies have performed: Some targeted and combination therapies have shown benefit in MPNs, but this compound is novel and its safety and effectiveness remain unproven in humans.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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 Criteria:

* 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.

Other protocol-defined Inclusion/Exclusion Criteria may apply.

Where this trial is running

Birmingham, Alabama and 46 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Myeloproliferative Neoplasms, Myelofibrosis, Essential thrombocythemia, Polycythemia Vera

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.