A Study to Evaluate INCA033989 Administered in Participants With Myeloproliferative Neoplasms
A Study to Evaluate INCA033989 Administered in Participants With Myeloproliferative Neoplasms
This study is being conducted to evaluate the safety, tolerability, dose-limiting toxicity
(DLT) and determine the maximum tolerated dose (MTD) and/or recommended dose(s) for expansion
(RDE) of INCA033989 administered in participants with myeloproliferative neoplasms.
(DLT) and determine the maximum tolerated dose (MTD) and/or recommended dose(s) for expansion
(RDE) of INCA033989 administered in participants with myeloproliferative neoplasms.
Leukemia
Phase I
Adults
Mol. targeted/Immunotherapy/Biologics
INCA033989
Savona, Michael
National
Vanderbilt University
03-18-2024
Eligibility
18 Years
BOTH
NO
Inclusion Criteria:
Life expectancy > 6 months.
Willingness to undergo a pretreatment and regular on-study BM biopsies and aspirates (as appropriate to disease).
Existing documentation from a qualified local laboratory of CALR exon-9 mutation.
Participants with MF or ET as defined in the protocol.
Exclusion Criteria:
Presence of any hematological malignancy other than ET, PMF, or post-ET MF.
Prior history of major bleeding, or thrombosis within the last 3 months prior to study enrollment.
Participants with laboratory values exceeding the protocol defined thresholds.
Has undergone any prior allogenic or autologous stem-cell transplantation or such transplantation is planned.
Active invasive malignancy over the previous 2 years.
History of clinically significant or uncontrolled cardiac disease.
Active HBV/HCV or known history of HIV.
Any prior chemotherapy, immunomodulatory drug therapy, immunosuppressive therapy, biological therapy, endocrine therapy, targeted therapy, antibody, or hypomethylating agent used to treat the participant's disease 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.
Life expectancy > 6 months.
Willingness to undergo a pretreatment and regular on-study BM biopsies and aspirates (as appropriate to disease).
Existing documentation from a qualified local laboratory of CALR exon-9 mutation.
Participants with MF or ET as defined in the protocol.
Exclusion Criteria:
Presence of any hematological malignancy other than ET, PMF, or post-ET MF.
Prior history of major bleeding, or thrombosis within the last 3 months prior to study enrollment.
Participants with laboratory values exceeding the protocol defined thresholds.
Has undergone any prior allogenic or autologous stem-cell transplantation or such transplantation is planned.
Active invasive malignancy over the previous 2 years.
History of clinically significant or uncontrolled cardiac disease.
Active HBV/HCV or known history of HIV.
Any prior chemotherapy, immunomodulatory drug therapy, immunosuppressive therapy, biological therapy, endocrine therapy, targeted therapy, antibody, or hypomethylating agent used to treat the participant's disease 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.
