A Study to Evaluate the Safety, Tolerability of INCB160058 in Participants With Myeloproliferative Neoplasms
Study Phase: Phase 1
Recruitment Status: Recruiting
Start Date: July 22, 2024
End Date: September 04, 2027
Inclusion Criteria:
- Age ≥ 18 years
- Participants with intermediate-1 or higher risk PMF, post-PV, of post-ET MF, histologically confirmed
- Evidence of minimum burden of disease based on symptoms and/or splenomegaly
- 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
- Previously treated with at least 1 JAK inhibitor for ≥ 12 weeks and resistant, refractory, intolerant to, or have lost response to JAK inhibitor treatment
Exclusion Criteria:
- Presence of a hematological malignancy requiring treatment, other than PMF, post-PV MF, or post-ET MF
- 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
- Active HBV/HCV or known HIV
- Any prior MF-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.
-
Conditions:
- Neoplasms
- Myeloproliferative Disorders