Myeloproliferative Neoplasms Clinical Trial
A Study to Evaluate INCA033989 Administered in Participants With Myeloproliferative Neoplasms
Summary
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.
Eligibility Criteria
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, 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.
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 14 Locations for this study
Duarte California, 91010, United States
Palo Alto California, 94304, United States
Miami Florida, 33136, United States
Tampa Florida, 33612, United States
Westwood Kansas, 66205, United States
Baltimore Maryland, 21287, United States
Boston Massachusetts, 02215, United States
Saint Louis Missouri, 63110, United States
New York New York, 10029, United States
New York New York, 10065, United States
Winston-Salem North Carolina, 27157, United States
Cleveland Ohio, 44195, United States
Nashville Tennessee, 37232, United States
Houston Texas, 77030, United States
How clear is this clinincal trial information?
Please confirm you are a US based health care provider:
Yes, I am a health care Provider No, I am not a health care providerSign Up Now.
Take Control of Your Disease Journey.
Sign up now for expert patient guides, personalized treatment options, and cutting-edge insights that can help you push for the best care plan.