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

Primary Investigator
Pettit, Kristen
Status
OPEN TO ACCRUAL
Phase
I
NCT Number
NCT06313593
UM Number
2026.005
Age Group
Adults
Management Group
CTSU - Oncology
Oncology Group
Hematological Malignancies
ID (Protocol)
60068
Secondary Protocol No
HUM00287957
Scope
Unspecified
Sponsor Type
Industry
Disease Site
Other Hematopoietic
Summary
This study is being conducted to assess the Safety, Tolerability, and Pharmacokinetics of INCB160058 in Participants With Myeloproliferative Neoplasms.

Eligibility: 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.