A Study to Evaluate INCA033989 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Myeloproliferative Neoplasms

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorIncyte Corporation

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

225 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Sponsors and collaborators