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A Study to Evaluate INCA033989 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Myeloproliferative Neoplasms
Trial Status: active
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 as a Monotherapy or in Combination With
Ruxolitinib in participants with myeloproliferative neoplasms.
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, with the exception of ruxolitinib for TGBs only, within 5 half-lives or 28 days (whichever is shorter) before the first dose of study treatment.
Participants undergoing treatment with G-CSF, GM-CSF, or TPO-R agonists at any time within 4 weeks before the first dose of study treatment. Other protocol-defined Inclusion/Exclusion Criteria may apply.
Additional locations may be listed on ClinicalTrials.gov for NCT06034002.
Locations matching your search criteria
United States
California
Duarte
City of Hope Comprehensive Cancer Center
Status: Active
Name Not Available
Palo Alto
Stanford Cancer Institute Palo Alto
Status: Active
Name Not Available
Florida
Miami
University of Miami Miller School of Medicine-Sylvester Cancer Center
Status: Active
Name Not Available
Kansas
Kansas City
University of Kansas Cancer Center
Status: Active
Name Not Available
Maryland
Baltimore
Johns Hopkins University/Sidney Kimmel Cancer Center