Clinical Trial 23781

• Overview

  Study Title:

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

  Summary:

  This is a First in Human Study being done to learn the safest dose (based on the frequency and severity of any side effects) of the INCB160058 for people with previously treated Myeloproliferative Neoplasms (MPNs) who have the JAK2V617F mutation. The Study will also evaluate the tolerability (how patient's bodies reacts to the study drug) and the efficacy (how well it works) of INCB160058 in treating MPNs.

  Objective:

  Primary: *To evaluate the safety, tolerability, and DLTs and determine the MTD and/or RDE(s) of INCB160058 administered as monotherapy or in combination with ruxolitinib Secondary: *To further characterize the safety profile of INCB160058 administered as monotherapy or in combination with ruxolitinib *To evaluate the PK of INCB160058 administered as monotherapy or in combination with ruxolitinib *To determine the preliminary efficacy of INCB160058

• Treatments

  Therapies:

  JAK1 and JAK2 Protein Kinases Inhibitor; JAK2V617F inhibitor

  Medications:

  INCB160058 (); Jakafi (Ruxolitinib); Ruxolitinib ()

• Inclusion Criteria

  Inclusion Criteria:
  • Age 18 years or older
  • Patients with myelofibrosis (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 or more and resistant, refractory, intolerant to, or have lost response to JAK inhibitor treatment.
  • Participants with MF: Histopathologically confirmed diagnosis of PMF, post-P-MF, or post-ET-MF.
  • Evidence of evaluable burden of disease: Radiologic confirmation of splenomegaly or Palpable spleen >/=5 cm below the left subcostal margin on physical examination at the screening visit.
  • ECOG performance status score of the following: 0 or 1 for the dose-escalation part, 0,1 or 2 for the dose expansion part.
  • 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 prior to cycle 1 day 1.
  • Willingness to avoid pregnancy or fathering children.
  • Participants with MF: Myeloblast count > Participants with PV: Confirmed diagnosis of PV according to 2022 IC criteria
  • Participants with ET: Confirmed diagnosis of ET according to 2022 IC criteria
  • Participants with ET: Participants who have been previously treated with at least 1 prior standard cytoreductive therapy and are resistant, refractory, intolerant to, or have lost response to treatment.
  • Other criteria apply

• Exclusion Criteria

  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 exclusions apply

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