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A Study of ZN-c3 in Women With Recurrent or Persistent Uterine Serous Carcinoma

PHASE2RECRUITING

This is a Phase 2 study to evaluate the clinical activity and safety of ZN-c3 (azenosertib) in adult women with recurrent or persistent uterine serous carcinoma (USC).

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Study details:

This is a Phase 2 open-label, multicenter study to evaluate the clinical activity and safety of ZN-c3 (also known as azenosertib; KP-2638) in adult women with recurrent or persistent uterine serous carcinoma (USC).

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

  • Females ≥18 years of age at the time of informed consent.
  • Histologically confirmed recurrent or persistent USC for which no other proven effective treatment options are available or any available standard of care therapy was not tolerated or was refused by the subject.
  • Subjects with endometrial carcinoma of mixed histology where the serous component comprises at least 5% of the tumor will be considered eligible.
  • Subjects with carcinosarcomas (even if there is a serous component) are not eligible.
  • Measurable disease per RECIST Guideline Version 1.1
  • Required prior therapy for endometrial cancer:
  • Treatment with a platinum-based chemotherapy regimen.
  • Treatment with a PD-(L)1 inhibitor
  • Known HER2-positive tumors: Treatment with at least 1 HER2-targeted therapy, except for subjects who are not clinically eligible.
  • Adequate hematologic and organ function
  • Exclusion criteria

  • Any of the following treatment interventions within the specified time frame prior to C1D1:
  • Major surgery within 28 days
  • Any chemotherapy or targeted tumor therapy within 14 days or 5 half-lives (whichever is shorter).
  • Radiation therapy within 21 days;
  • Autologous or allogeneic stem cell transplant within 3 months.
  • Current use of any other investigational drug therapy <28 days or 5 half-lives (whichever is shorter).
  • Prior therapy with ZN-c3 or any other WEE1 inhibitor, ATR inhibitor, or CHK1/2 inhibitor for USC.
  • A serious illness or medical condition(s) including, but not limited to: Any evidence of bowel obstruction as determined by air/fluid levels on computed tomography (CT) scan, recent hospitalization for bowel obstruction within 3 months prior to C1D1, or recurrent paracentesis or thoracentesis within 6 weeks prior to C1D1.
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    Eligibility

    Age eligible for study : 18 and older

    Healthy volunteers accepted : No

    Gender eligible for study: Female

    Things to know

    Study dates

    Study start: 2021-07-28

    Primary completion: 2024-11-30

    Study completion finish: 2025-05-31

    study type

    Study type

    TREATMENT

    phase

    Phase

      PHASE2

    trial

    Trial ID

    NCT04814108

    Intervention or treatment

    DRUG: ZN-c3

    Conditions

    • Uterine Serous Carcinoma
    Image related to Uterine Serous Carcinoma
    • Condition: Uterine Serous Carcinoma

    • DRUG: ZN-c3

    • Concord, New South Wales, Australia and more

    • Sponsor: K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc

    Find a site

    Closest Location:

    Concord Repatriation General Hospital

    Research sites nearby

    Select from list below to view details:

    • Concord Repatriation General Hospital

      Concord, New South Wales, Australia

    • Cabrini Hospital Malvern

      Malvern, Victoria, Australia

    • Peter MacCallum Cancer Centre

      Melbourne, Victoria, Australia

    • Sir Charles Gairdner Hospital

      Nedlands, Western Australia, Australia

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    Study Plan

    This section provides details of the study plan, including how the study is designed and what the study is measuring.

    How is the study designed?

    Participant Group/ArmIntervention/Treatment
    EXPERIMENTAL: ZN-c3 Single Agent
    • ZN-c3 (azenosertib) taken orally with food
    DRUG: ZN-c3
    • ZN-c3 is an investigational drug.

    What is the study measuring?

    Primary outcome

    Primary Outcome MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    Frequency and severity of TEAEs and incidence of dose modificationsTo determine the safety and tolerability of ZN-c3 in subjects with recurrent or persistent USC.2 years
    Objective Response Rate as defined by the revised RECIST v1.1 as assessed by ICRTo investigate the antitumor activity of ZN-c3 in subjects with recurrent or persistent USC2 years

    Secondary outcome

    Secondary Outcome MeasureSecondary Outcome DescriptionSecondary Outcome Time Frame
    Objective Response Rate as defined by the revised RECIST v1.1. and assessed by ICR and the Investigator.To investigate the antitumor activity of ZN-c3 in subjects with recurrent or persistent USC at different doses/schedules2 years
    Duration of Response as defined by the revised RECIST v1.1. and assessed by ICR and the Investigator.To investigate the antitumor activity of ZN-c3 in subjects with recurrent or persistent USC at different doses/schedules2 years
    Progression Free Survival as defined by the revised RECIST v1.1. and assessed by ICR and the Investigator.To investigate the antitumor activity of ZN-c3 in subjects with recurrent or persistent USC at different doses/schedules2 years
    Clinical Benefit Rate as defined by the revised RECIST v1.1. and assessed by ICR and the Investigator.To investigate the antitumor activity of ZN-c3 in subjects with recurrent or persistent USC at different doses/schedules2 years
    Time To Response as defined by the revised RECIST v1.1. and assessed by ICR and the Investigator.To investigate the antitumor activity of ZN-c3 in subjects with recurrent or persistent USC at different doses/schedules2 years

    Frequently Asked Questions

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    References

    Clinical Trials Gov: A Study of ZN-c3 in Women With Recurrent or Persistent Uterine Serous Carcinoma

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