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Study of INCB160058 for Myeloproliferative Neoplasms

This study is testing a new oral medication called INCB160058 in people with Myeloproliferative Neoplasms (blood cancers where the bone marrow makes too many blood cells). The main goals are to see how safe INCB160058 is, how well your body tolerates it, and how your body processes the drug. You may be eligible if you are at least 18 years old and have certain types of Myelofibrosis (MF), especially if you've already tried another treatment called a JAK inhibitor. The study will look at side effects and other safety measures for up to two years and 30 days. The current status of this study is unclear, but it plans to enroll about 186 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll about 186 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for side effects and other safety measures for up to 2 years and 30 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.

NCT06313593

A Study to Evaluate the Safety, Tolerability of INCB160058 in Participants With Myeloproliferative Neoplasms

Active, Not Recruiting
PHASE1Ages 18+InterventionalTreatment
Incyte Corporation
~37 participants
Updated 2026-08-12 on ClinicalTrials.gov
What's tested:INCB160058Standard disease-directed therapy

At a glance

Recruiting sites
0 of 30 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
+2 more outcomes measured

Conditions

Myeloproliferative Neoplasms

Explore related trials

Essential ThrombocythemiaMyelofibrosisMyeloproliferative disorderPolycythemia VeraJAK2 Gene

Where it's being run

30 sites across 19 states
New York3
Germany3
Italy3
Quebec2
France2
Norway2
Switzerland2
United Kingdom2

Study leadership

  • Incyte Medical · STUDY_DIRECTOR · Incyte Corporation

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Age ≥ 18 years
MF:
Intermediate-1 or higher risk PMF, post-PV MF, or post-ET MF with evidence of minimum burden of disease based on splenomegaly, and for the monotherapy cohort, participants must have been previously treated with at least 1 JAK inhibitor for ≥ 12 weeks and resistant, refractory, intolerant to, or have lost response to JAK inhibitor treatment.
For the MF SubOpt R cohort: Therapeutic regimen prior to enrollment as defined in the protocol and unlikely to benefit from further monotherapy in the opinion of the investigator.
PV: Confirmed diagnosis of PV and previously treated with at least 1 prior standard cytoreductive therapy and are resistant, refractory, intolerant to, or have lost response to treatment.
ET: Confirmed diagnosis of high-risk ET as defined in the protocol and previously treated with at least 1 prior standard cytoreductive therapy and are resistant, refractory, intolerant to, or have lost response to treatment.
Life expectancy \> 6 months.
Willingness to undergo a pretreatment and regular on-study bone marrow biopsies and aspirations (as appropriate to disease).
Existing documentation of JAK2V617F mutation from a qualified local laboratory.

Exclusion

Presence of a hematological malignancy requiring treatment, other than PMF, post-PV MF, post-ET MF, PV, or ET.
Prior history of major bleeding or thrombosis within the 3 months prior to study enrollment.
Participants with abnormal hematologic, hepatic, or renal function based on laboratory evaluation.
Has undergone prior allogenic or autologous stem-cell transplantation or allogenic stem-cell transplantation is planned
Active invasive malignancy.
Significant concurrent, uncontrolled medical condition.
Acute or chronic HBV, active HCV or known HIV.
Any prior MPN-directed therapy within 5 half-lives or 28 days (whichever is shorter) before the first dose of study treatment.
Participants undergoing treatment with G-CSF or GM-CSF, romiplostim, or eltrombopag 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 2 years and 30 days

    Defined as adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug.

  • Number of participants with TEAEs leading to dose modification or discontinuationUp to 2 years and 30 days

    Number of participants with TEAEs leading to dose modification or discontinuation.