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.

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.

Linear Clinical Research, Perth, Western Australia, 6009
Contact  +61 08 6382 5100
cancertrialshaem4@linear.org.au

Incyte Corporation

Phase 1

INCA036978-101

NCT07441694