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Evaluating the safety and tolerability of INCB160058 for patients with myeloproliferative neoplasms

A Phase 1, Open-Label, Multicenter Study of INCB160058 in Participants With Myeloproliferative Neoplasms

Phase 1 Interventional Incyte Corporation · NCT06313593

This study is testing a new drug called INCB160058 to see if it is safe and works well for adults with myeloproliferative neoplasms who haven't responded to other treatments.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment186 (estimated)
Ages18 Years and up
SexAll
SponsorIncyte Corporation Industry-sponsored
Locations30 sites (Birmingham, Alabama and 29 other locations)
Trial IDNCT06313593 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety, tolerability, and pharmacokinetics of a new drug called INCB160058 in patients diagnosed with myeloproliferative neoplasms. Participants must be at least 18 years old and have previously been treated with JAK inhibitors but are resistant or intolerant to those treatments. The study involves regular monitoring through bone marrow biopsies to assess the drug's effects over time. The goal is to determine how well the drug works and its safety profile in this patient population.

Who should consider this trial

Good fit: Ideal candidates include adults with myeloproliferative neoplasms who have previously been treated with JAK inhibitors and have shown resistance or intolerance to those treatments.

Not a fit: Patients who have not been previously treated with JAK inhibitors or those with a life expectancy of less than six months may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with myeloproliferative neoplasms who have not responded to existing therapies.

How similar studies have performed: Other studies have explored treatments for myeloproliferative neoplasms, but the specific approach of using INCB160058 is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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 Criteria:

* 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.

Other protocol-defined Inclusion/Exclusion Criteria may apply.

Where this trial is running

Birmingham, Alabama and 29 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Myeloproliferative NeoplasmsINCB160058Myelofibrosis
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.