About this trial
This study is being conducted to evaluate the safety, tolerability, and 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.
Eligibility criteria
Qualifiers
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 and ET as defined in the protocol.
Disqualifiers
Presence of any hematological malignancy other than ET, PMF, or post-ET MF.
Active invasive malignancy over the previous 2 years.
Active HBV/HCV, HIV.
History of clinically significant or uncontrolled cardiac disease.
Trial design
Treatments tested in this trial
- INCA033989
- Ruxolitinib
Treatment groups
7
Treatment groupsSee each treatment group below.