Overview
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 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.
