UPCC 36425 A Phase 1, Open-Label, Multicenter Study of INCB160058 in Participants With Myeloproliferative Neoplasms

Study of Investigational Medication in Myeloproliferative Neoplasms

Enrolling By Invitation
18 years or above
All
Phase 1
186 participants needed
1 Location

Brief description of study

This study is being conducted to assess the Safety, Tolerability, and Pharmacokinetics of INCB160058 in Participants With Myeloproliferative Neoplasms.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Myeloproliferative Neoplasms
  • Age: 18 years or above
  • Gender: All

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.

This study investigates the safety, tolerability, and pharmacokinetics of an investigational medication in participants with myeloproliferative neoplasms. This study is for those who have been previously treated with a JAK inhibitor and have specific types of myeloproliferative neoplasms, such as primary myelofibrosis, post-polycythemia vera myelofibrosis, or post-essential thrombocythemia myelofibrosis.

Participants in the study will undergo procedures including pretreatment and regular on-study bone marrow biopsies and aspirations as appropriate to their disease. These procedures help in understanding how the investigational medication affects the bone marrow and overall disease progression.

  • Who can participate: Adults aged 18 years and older with certain myeloproliferative neoplasms, previously treated with a JAK inhibitor, may be eligible if they meet specific disease criteria and have a life expectancy of over 6 months.
  • Study details: Participants will receive the investigational medication and undergo bone marrow biopsies to assess the treatment's effects, requiring documentation of the JAK2V617F mutation from a qualified laboratory.
Updated on 04 May 2026. Study ID: 25-1262
If you need assistance finding a non-cancer clinical research study or if you have any questions, please email psom-ocr@pobox.upenn.edu For Cancer trials contact Penn Medicine's Cancer Trial Navigator at: PMCancerResearch@pennmedicine.upenn.edu or 215-349-8245

Study is selecting its participants from a population, or group of people, decided on by the researchers in advance.

Contact Abramson Cancer Center Navigator