This study is being conducted to evaluate the safety, tolerability, dose-limiting toxicity (DLT) and determine the maximum tolerated dose (MTD) and/or recommended dose(s) for expansion (RDE) of INCA033989 administered as a Monotherapy or in Combination With Ruxolitinib in participants with myeloproliferative neoplasms.
Life expectancy > 6 months.
Willingness to undergo a pretreatment and regular on-study BM biopsies and aspirates (as appropriate to disease).
Existing documentation from a qualified local laboratory of CALR exon-9 mutation.
Participants with MF or ET as defined in the protocol.
Presence of any hematological malignancy other than ET, PMF, or post-ET MF.
Prior history of major bleeding, or thrombosis within the last 3 months prior to study enrollment.
Participants with laboratory values exceeding the protocol defined thresholds.
Has undergone any prior allogenic or autologous stem-cell transplantation or such transplantation is planned.
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Treatment groupsSee each treatment group below.
Incyte Corporation
Lead sponsor