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Study of INCA033989 for Myeloproliferative Neoplasms

This study is looking into a new treatment, INCA033989, for people with myeloproliferative neoplasms (a group of blood cancers). Researchers want to see how safe INCA033989 is, how well your body tolerates it, and find the best dose when given alone or with ruxolitinib, another medication. To join, you must be at least 18 years old, have a life expectancy of more than 6 months, and be willing to have bone marrow biopsies. You also need to have a specific genetic change called a CALR exon-9 mutation and have been diagnosed with Myelofibrosis (MF) or Essential Thrombocythemia (ET). The study will consider itself successful if it can identify the safe dose and understand any side effects. The current recruitment status is unclear.

Study design
This is an interventional study planning to enroll 290 participants. It is testing INCA033989 as a single treatment or in combination with ruxolitinib.
What's involved
You would need to undergo pretreatment and regular bone marrow biopsies and aspirates. The study will track side effects for up to 3 years and 60 days.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for treatment-emergent adverse events (side effects) for up to 3 years and 60 days.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06034002

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Incyte Corporation
~290 participants
Updated 2026-04-17 on ClinicalTrials.gov
What's tested:INCA033989Ruxolitinib

At a glance

Recruiting sites
13 of 13 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with Dose Limiting Toxicities (DLTs)
Measured over Up to 28 days
+1 more outcome measured

Conditions

Myeloproliferative Neoplasms

Explore related trials

Essential ThrombocythemiaMyelofibrosisCALR Gene

Where it's being run

13 sites across 11 states
California2
New York2
Florida1
Kansas1
Maryland1
Massachusetts1
Missouri1
North Carolina1

Study leadership

  • Incyte Medical Monitor · STUDY_DIRECTOR · Incyte Corporation

Who to contact

Incyte Corporation Call Center (US)
[email protected]
1.855.463.3463
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.

Exclusion

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.
Active invasive malignancy over the previous 2 years.
History of clinically significant or uncontrolled cardiac disease.
Active or chronic HBV or active HCV or known history of HIV.
Any prior chemotherapy, immunomodulatory drug therapy, immunosuppressive therapy, biological therapy, endocrine therapy, targeted therapy, antibody, or hypomethylating agent used to treat the participant's disease, with the exception of ruxolitinib for TGBs only, within 5 half-lives or 28 days (whichever is shorter) before the first dose of study treatment.
Participants undergoing treatment with G-CSF, GM-CSF, or TPO-R agonists at any time within 4 weeks before the first dose of study treatment.

What this trial measures

  • Number of participants with Dose Limiting Toxicities (DLTs)Up to 28 days

    Dose-limiting toxicity will be defined as the occurrence of any of the toxicities as per protocol.

  • Number of participants with Treatment-emergent Adverse Events (TEAEs)Up to 3 years and 60 days

    Defined as adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug, including those leading to dose modification or discontinuation.