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.

View Eligibility Criteria

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.

Study is for people with:

Myeloproliferative Neoplasms

Phase:

Phase 1

Estimated Enrollment:

140

Study ID:

NCT06034002

Recruitment Status:

Recruiting

Sponsor:

Incyte Corporation

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There are 14 Locations for this study

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City of Hope Medical Center
Duarte California, 91010, United States
Stanford Cancer Institute
Palo Alto California, 94304, United States
University of Miami Health System
Miami Florida, 33136, United States
Moffitt Cancer Center
Tampa Florida, 33612, United States
The University of Kansas Cancer Center
Westwood Kansas, 66205, United States
Johns Hopkins Hospital
Baltimore Maryland, 21287, United States
Dana Farber Cancer Institute
Boston Massachusetts, 02215, United States
Washington University School of Medicine
Saint Louis Missouri, 63110, United States
Icahn School of Medicine At Mount Sinai
New York New York, 10029, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
Wake Forest Baptist Medical Center
Winston-Salem North Carolina, 27157, United States
Cleveland Clinic
Cleveland Ohio, 44195, United States
Vanderbilt University Medical Center
Nashville Tennessee, 37232, United States
Md Anderson Cancer Center
Houston Texas, 77030, United States

How clear is this clinincal trial information?

Study is for people with:

Myeloproliferative Neoplasms

Phase:

Phase 1

Estimated Enrollment:

140

Study ID:

NCT06034002

Recruitment Status:

Recruiting

Sponsor:


Incyte Corporation

How clear is this clinincal trial information?

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