Study of INCA036978 in Participants With Myeloproliferative Neoplasms
A Phase 1, Open-Label, Multicenter Study of INCA036978 in Participants With Myeloproliferative Neoplasms
Incyte Corporation
218 participants
Mar 29, 2026
INTERVENTIONAL
Conditions
Summary
This study will be conducted to determine the safety, tolerability, dose-limiting toxicity (DLT)s, and maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE)s of INCA036978 administered as monotherapy and in combination with a standard disease-directed therapy.
Eligibility
Inclusion Criteria3
- 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 Criteria10
- 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.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
INCA036978 will be administered at protocol defined dose.
A standard disease-directed therapy will be administered according to Prescribing Information/SmPC.
Locations(45)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07441694