A Study to Evaluate the Safety, Tolerability of INCB160058 in Participants With Myeloproliferative Neoplasms
A Study to Evaluate the Safety, Tolerability of INCB160058 in Participants With Myeloproliferative Neoplasms
This study is being conducted to assess the Safety, Tolerability, and Pharmacokinetics of INCB160058 in Participants With Myeloproliferative Neoplasms.
Not Available
Phase I
Adults
Mol. targeted/Immunotherapy/Biologics
INCB160058
Kishtagari, Ashwin
National
Vanderbilt University
03-26-2025
Eligibility
18 Years and older
ALL
false
Inclusion Criteria:
Age 18 years
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 previously treated with at least 1 JAK inhibitor for 12 weeks and resistant, refractory, intolerant to, or have lost response to JAK inhibitor treatment.
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 previously treated with at least 1 JAK inhibitor for 12 weeks and resistant, refractory, intolerant to, or have lost response to JAK inhibitor treatment.
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.
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.
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.
Life expectancy > 6 months.
Willingness to undergo a pretreatment and regular on-study bone marrow biopsies and aspirations (as appropriate to disease).
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.
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.
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.
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.
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
Has undergone prior allogenic or autologous stem-cell transplantation or allogenic stem-cell transplantation is planned
Active invasive malignancy.
Active invasive malignancy.
Significant concurrent, uncontrolled medical condition.
Significant concurrent, uncontrolled medical condition.
Acute or chronic HBV, active HCV or known HIV.
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.
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.
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.
Other protocol-defined Inclusion/Exclusion Criteria may apply.
Age 18 years
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 previously treated with at least 1 JAK inhibitor for 12 weeks and resistant, refractory, intolerant to, or have lost response to JAK inhibitor treatment.
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 previously treated with at least 1 JAK inhibitor for 12 weeks and resistant, refractory, intolerant to, or have lost response to JAK inhibitor treatment.
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.
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.
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.
Life expectancy > 6 months.
Willingness to undergo a pretreatment and regular on-study bone marrow biopsies and aspirations (as appropriate to disease).
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.
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.
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.
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.
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
Has undergone prior allogenic or autologous stem-cell transplantation or allogenic stem-cell transplantation is planned
Active invasive malignancy.
Active invasive malignancy.
Significant concurrent, uncontrolled medical condition.
Significant concurrent, uncontrolled medical condition.
Acute or chronic HBV, active HCV or known HIV.
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.
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.
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.
Other protocol-defined Inclusion/Exclusion Criteria may apply.
