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NCT06034002PHASE1Recruiting

A Study to Evaluate INCA033989 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Myeloproliferative Neoplasms

Incyte Corporation

Start Date

12/4/2023

Completion Date

10/29/2028

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 as a Monotherapy or in Combination With Ruxolitinib in participants with myeloproliferative neoplasms.

Eligibility Criteria

Age Range: 18 years to No maximum

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 or chronic HBV or active 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.

Interventions

DRUG

INCA033989

DRUG

Ruxolitinib

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Conditions

Myeloproliferative Neoplasms

Locations

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

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

St Louis, Missouri 63108

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