A Study to Evaluate INCA033989 Administered in Participants With Myeloproliferative Neoplasms

Last updated: February 13, 2025
Sponsor: Incyte Corporation
Overall Status: Active - Recruiting

Phase

1

Condition

White Cell Disorders

Neoplasms

Red Blood Cell Disorders

Treatment

INCA033989

Clinical Study ID

NCT06034002
INCA33989-102
  • Ages > 18
  • All Genders

Study 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

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

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 tostudy enrollment.

  • Participants with laboratory values exceeding the protocol defined thresholds.

  • Has undergone any prior allogenic or autologous stem-cell transplantation or suchtransplantation 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, orhypomethylating 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 timewithin 4 weeks before the first dose of study treatment.

Other protocol-defined Inclusion/Exclusion Criteria may apply.

Study Design

Total Participants: 140
Treatment Group(s): 1
Primary Treatment: INCA033989
Phase: 1
Study Start date:
December 04, 2023
Estimated Completion Date:
October 29, 2028

Connect with a study center

  • City of Hope Medical Center

    Duarte, California 91010
    United States

    Active - Recruiting

  • Stanford Cancer Institute

    Palo Alto, California 94304
    United States

    Active - Recruiting

  • University of Miami Health System

    Miami, Florida 33136
    United States

    Active - Recruiting

  • Moffitt Cancer Center

    Tampa, Florida 33612
    United States

    Site Not Available

  • The University of Kansas Cancer Center

    Westwood, Kansas 66205
    United States

    Active - Recruiting

  • Johns Hopkins Hospital

    Baltimore, Maryland 21287
    United States

    Active - Recruiting

  • Dana Farber Cancer Institute

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

  • Washington University School of Medicine

    Saint Louis, Missouri 63108
    United States

    Active - Recruiting

  • Icahn School of Medicine At Mount Sinai

    New York, New York 10029
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10065
    United States

    Active - Recruiting

  • Wake Forest Baptist Medical Center

    Winston-Salem, North Carolina 27157
    United States

    Active - Recruiting

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37232
    United States

    Active - Recruiting

  • Md Anderson Cancer Center

    Houston, Texas 77030
    United States

    Active - Recruiting

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