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

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

Phase

1

Condition

Neoplasms

White Cell Disorders

Red Blood Cell Disorders

Treatment

INCA033989

Ruxolitinib

Clinical Study ID

NCT05936359
INCA 33989-101
2022-502514-86-00
  • Ages > 18
  • All Genders

Study Summary

This study is being conducted to evaluate the safety, tolerability, and 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

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 and ET as defined in the protocol.

Exclusion

Exclusion Criteria:

  • Presence of any hematological malignancy other than ET, PMF, or post-ET MF.

  • Active invasive malignancy over the previous 2 years.

  • Active HBV/HCV, HIV.

  • History of clinically significant or uncontrolled cardiac disease.

  • Has undergone any prior allogenic or autologous stem-cell transplantation or suchtransplantation is planned.

  • Laboratory values outside the Protocol-defined ranges.

  • Participants undergoing treatment with G-CSF, GM-CSF, or TPO-R agonists at any timewithin 4 weeks before the first dose of study treatment.

  • Prior history of major bleeding, or thrombosis within the last 3 months prior tostudy enrollment.

  • 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.

  • For TGBs only: Undergoing treatment with a potent/strong inhibitor or inducer of CYP 3A4/5 within 14 days or 5 half-lives (whichever is longer) before the first dose ofstudy treatment, or expected to receive such treatment during the study.

Other protocol-defined Inclusion/Exclusion Criteria may apply.

Study Design

Total Participants: 225
Treatment Group(s): 2
Primary Treatment: INCA033989
Phase: 1
Study Start date:
September 25, 2023
Estimated Completion Date:
February 29, 2028

Connect with a study center

  • Royal Brisbane and Women'S Hospital

    Herston, Queensland 04029
    Australia

    Active - Recruiting

  • Royal Adelaide Hospital

    Adelaide, South Australia 05000
    Australia

    Active - Recruiting

  • Peter Maccallum Cancer Centre

    Melbourne, Victoria 03000
    Australia

    Active - Recruiting

  • The Alfred Hospital

    Melbourne, Victoria 03004
    Australia

    Active - Recruiting

  • Peter Maccallum Cancer Centre

    North Melbourne, Victoria 03051
    Australia

    Site Not Available

  • Princess Margaret Cancer Center

    Toronto, Ontario M5G 2M9
    Canada

    Active - Recruiting

  • Hopital Maisonneuve-Rosemont, Montreal, Qc

    Montreal, Quebec QC H1T 2M4
    Canada

    Active - Recruiting

  • Odense University Hospital

    Odense C, 05000
    Denmark

    Site Not Available

  • Sjaellands Universitetshospital

    Roskilde, 04000
    Denmark

    Active - Recruiting

  • Vejle Hospital

    Vejle, 07100
    Denmark

    Active - Recruiting

  • Institut Bergonie

    Bordeaux, 33076
    France

    Active - Recruiting

  • Chu Nimes

    Nimes, 30029
    France

    Active - Recruiting

  • Hospital Saint Louis

    Paris, 75010
    France

    Active - Recruiting

  • Institut Gustave Roussy

    Villejuif Cedex, 94805
    France

    Active - Recruiting

  • University Medical Center Rwth Aachen

    Aachen, 52074
    Germany

    Active - Recruiting

  • Universitatsklinikum Halle (Saale)

    Halle, 06120
    Germany

    Active - Recruiting

  • Universitatsklinikum Ulm

    ULM, 89081
    Germany

    Active - Recruiting

  • Universitätsklinikum Ulm

    ULM, 89081
    Germany

    Site Not Available

  • Aou Policlinico S. Orsola-Malpighi Bologna

    Bologna, 40138
    Italy

    Active - Recruiting

  • Aou Policlinico S. Orsola-Malpighi Bologna&Nbsp;

    Bologna, 40138
    Italy

    Active - Recruiting

  • Azienda Ospedaliero-Universitaria Di Bologna Policlinico S. Orsola - Malpighi

    Bologna, 40138
    Italy

    Active - Recruiting

  • L Azienda Ospedaliero-Universitaria Di Bologna Policlinico S. Orsola - Malpighi

    Bologna, 40138
    Italy

    Site Not Available

  • Azienda Ospedaliero-Universitaria Careggi (Aouc)

    Firenze, 50134
    Italy

    Active - Recruiting

  • Fondazione Irccs Ca Granda Ospedale Maggiore

    Milan, 20122
    Italy

    Active - Recruiting

  • National Cancer Center Hospital East

    Chiba, 277-8577
    Japan

    Active - Recruiting

  • Kagoshima University Hospital

    Kagoshima, 890-8520
    Japan

    Active - Recruiting

  • Osaka Metropolitan University Hospital

    Osaka, 545-8586
    Japan

    Active - Recruiting

  • Osaka City University Hospital

    Osaka-fu, 545-8586
    Japan

    Site Not Available

  • Mie University Hospital

    TSU, 514-0001
    Japan

    Active - Recruiting

  • Nippon Medical School Hospital

    Tokyo, 113-8603
    Japan

    Active - Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid, 28041
    Spain

    Active - Recruiting

  • Hospital Universitari I Politecnic La Fe

    Valencia, 46026
    Spain

    Active - Recruiting

  • Guys and St Thomas Nhs Foundation Trust

    London, SE1 9RT
    United Kingdom

    Active - Recruiting

  • The Christie Nhs Foundation Trust Uk

    Manchester, M20 4BV
    United Kingdom

    Active - Recruiting

  • University of Oxford

    Oxford, OX3 7LE
    United Kingdom

    Active - Recruiting

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