MAESTRA 1

  • Research type

    Research Study

  • Full title

    A Phase 2, Single-Arm Study of INCB123667 in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 Overexpression (MAESTRA 1)

  • IRAS ID

    1012940

  • Contact name

    Helen Watson

  • Contact email

    iconregulatoryaffairs@iconplc.com

  • Sponsor organisation

    Incyte Corporation

  • Clinicaltrials.gov Identifier

    NCT07023627

  • Research summary

    This study is testing a new treatment, INCB123667 in participants with platinum-resistant ovarian cancer whose cancer shows high levels of a protein called cyclin E1. In some cancers, including ovarian cancer, cyclin E1 is often present at higher-than-normal levels (known as cyclin E1 overexpression). This overexpression overstimulates CDK2, which may cause cancer cells to grow and spread more quickly than normal. This study aims to determine whether blocking CDK2 may help slow down or stop the growth of cancer cells. INCB123667 is designed to block CDK2. By doing so, it may help stop the growth of cancer cells that rely on high levels of cyclin E1.
    Ovarian cancer is the third most common gynaecological malignancy, causing significant morbidity and mortality, with an estimated 325,000 new cases and 207,000 deaths worldwide in 2022 (GCO, 2022)
    The risks of taking INCB123667 are not yet fully known and may vary depending on the disease the participant is being treated for and other medical conditions they may have.
    The Sponsor, Incyte Corporation, will provide the treatment and pay for all study test and procedures, performed for the purpose of this study.

  • REC name

    East Midlands - Leicester Central Research Ethics Committee

  • REC reference

    25/EM/0260

  • Date of REC Opinion

    16 Dec 2025

  • REC opinion

    Further Information Favourable Opinion