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CompletedNCT04814108Updated Mar 18, 2026

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

A Phase 2 interventional study of Azenosertib in Uterine Serous Carcinoma, sponsored by K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc. Completed at 56 sites in 4 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-18.

Sponsored by K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
92
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study summary

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).

Read the detailed description

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).

02

Conditions studied

  • Uterine Serous Carcinoma

Keywords

  • uterus
  • uterine
  • endometrial
  • endometrium
  • serous carcinoma
  • wee1
  • Wee-1
  • usc
  • Uterine Serous Carcinoma
  • serous
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  1. Females ≥18 years of age at the time of informed consent.
  2. 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.
  3. Measurable disease per RECIST Guideline Version 1.1
  4. Required prior therapy for endometrial cancer:

    1. Treatment with a platinum-based chemotherapy regimen.
    2. Treatment with a PD-(L)1 inhibitor
    3. Known HER2-positive tumors: Treatment with at least 1 HER2-targeted therapy, except for subjects who are not clinically eligible.
  5. Adequate hematologic and organ function

Exclusion criteria

EXCLUSION CRITERIA

  1. Any of the following treatment interventions within the specified time frame prior to C1D1:

    1. Major surgery within 28 days
    2. Any chemotherapy or targeted tumor therapy within 14 days or 5 half-lives (whichever is shorter).
    3. Radiation therapy within 21 days;
    4. Autologous or allogeneic stem cell transplant within 3 months.
    5. Current use of any other investigational drug therapy \<28 days or 5 half-lives (whichever is shorter).
  2. Prior therapy with ZN-c3 or any other WEE1 inhibitor, ATR inhibitor, or CHK1/2 inhibitor for USC.
  3. 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.
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
92 participants (actual)

Study arms

  • Experimental
    Azenosertib Single Agent

    Azenosertib (ZN-c3) taken orally with food

    Drug: Azenosertib

Interventions

  • DrugAzenosertib

    Azenosertib is an investigational drug.

    Also known as: ZN-c3

05

What researchers measure

Primary outcomes

  1. Frequency and severity of TEAEs

    To determine the safety and tolerability of ZN-c3 in subjects with recurrent or persistent USC.

    Time frame: 2 years

  2. Objective Response Rate as defined by the revised RECIST v1.1 as assessed by ICR

    To investigate the antitumor activity of ZN-c3 in subjects with recurrent or persistent USC

    Time frame: 2 years

Secondary outcomes

  1. 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/schedules

    Time frame: 2 years

  2. 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/schedules

    Time frame: 2 years

  3. 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/schedules

    Time frame: 2 years

  4. 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/schedules

    Time frame: 2 years

  5. 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/schedules

    Time frame: 2 years

06

Study locations

56 sites
  • Alaska Women's Cancer Care
    Anchorage, Alaska 99508, United States
  • Honor Health
    Phoenix, Arizona 85016, United States
  • Arizona Oncology Associates Wilmot HOPE
    Tucson, Arizona 85711, United States
  • Banner University Medical Center Tucson
    Tucson, Arizona 85719, United States
  • University of California Irvine Medical Center
    Orange, California 92868, United States
  • University of California San Francisco at Mission Bay
    San Francisco, California 94158, United States
  • Mount Sinai Medical Center
    Miami Beach, Florida 33140, United States
  • Sarasota Memorial Hospital
    Sarasota, Florida 34239, United States
  • University of South Florida
    Tampa, Florida 33606, United States
  • Northside Hospital
    Atlanta, Georgia 30342, United States
  • Georgia Cancer Center at Augusta University
    Augusta, Georgia 30912, United States
  • Northwestern University
    Evanston, Illinois 60208, United States
  • Maryland Oncology Hematology
    Annapolis, Maryland 21401, United States
  • University of Maryland Medical Center
    Baltimore, Maryland 21201, United States
  • Oakland Medical Group
    Detroit, Michigan 48201, United States
  • Corewell Health
    Grand Rapids, Michigan 49503, United States
  • Revive Clinical Research
    Sterling, Michigan 48659, United States
  • HCA Midwest Health Kansas City Research
    Kansas City, Missouri 64132, United States
  • Center of Hope
    Reno, Nevada 89511, United States
  • Rutgers Cancer Institute of New Jersey
    New Brunswick, New Jersey 08901, United States
  • Optimum Clinical Research Group- Women's Oncology
    Albuquerque, New Mexico 87109, United States
  • Westchester Medical Center
    Hawthorne, New York 10532, United States
  • University of Cincinnati
    Cincinnati, Ohio 45219, United States
  • Oncology Hematology Care
    Cincinnati, Ohio 45242, United States
  • Trihealth Cancer Institute
    Cincinnati, Ohio 45242, United States
  • Ohio State University James Cancer Hospital
    Columbus, Ohio 43210, United States
  • University of Oklahoma Peggy and Charles Stephenson Cancer Center
    Oklahoma City, Oklahoma 73104, United States
  • Willamette Valley Cancer Institute
    Eugene, Oregon 97401, United States
  • Providence Portland Medical Center
    Portland, Oregon 97213, United States
  • Northwest Cancer Specialists
    Portland, Oregon 97227, United States
  • Temple University Hospital
    Philadelphia, Pennsylvania 19140, United States
  • Ascension St. Thomas Midtown Hospital
    Nashville, Tennessee 37236, United States
  • Texas Oncology Austin
    Austin, Texas 78705, United States
  • Texas Oncology Fort Worth Cancer Center
    Fort Worth, Texas 76104, United States
  • MD Anderson Cancer Center
    Houston, Texas 77030, United States
  • Texas Oncology Gulf Coast
    Houston, Texas 77089, United States
  • Texas Oncology San Antonio
    San Antonio, Texas 78240, United States
  • University of Virginia Cancer Center
    Charlottesville, Virginia 22908, United States
  • VCU Health System
    Richmond, Virginia 23298, United States
  • Virginia Cancer Specialists
    Warrenton, Virginia 20186, United States
  • Medical College of Wisconsin
    Milwaukee, Wisconsin 53226, United States
  • Concord Repatriation General Hospital
    Concord, New South Wales 2139, Australia
  • Northern Cancer Institute
    St Leonards, New South Wales 2065, Australia
  • Icon Cancer Centre- Chermside
    Brisbane, Queensland 4032, Australia
  • Mater Cancer Care Centre, Mater Misericordiae Limited
    Brisbane, Queensland 4101, Australia
  • Burnside War Memorial Hospital
    Toorak Gardens, South Australia 6065, Australia
  • Cabrini Hospital Malvern
    Malvern, Victoria 3144, Australia
  • Peter MacCallum Cancer Centre
    Melbourne, Victoria 3000, Australia
  • Sir Charles Gairdner Hospital
    Nedlands, Western Australia 6009, Australia
  • Sunnybrook Health Sciences Centre
    Toronto, Ontario M4N 3M5, Canada
  • Chu de Quebec-Universite
    Québec, Quebec G1R 3S1, Canada
  • LTD High Technology Hospital Medcenter
    Batumi, Adjara 6000, Georgia
  • Rustavi Clinic
    Rustavi, Kvemo Kartli 3700, Georgia
  • Acad. Fridon Todua Medical Center
    Tbilisi, 0112, Georgia
  • LTD Innova Medical Center
    Tbilisi, 0144, Georgia
  • LTD TIM-Tbilisi Innova of Medicine
    Tbilisi, 0160, Georgia
07

Registry details

Key details

Study ID
NCT04814108
Lead sponsor
K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc
Responsible party
Sponsor
First posted
Mar 24, 2021
Start date
Jul 28, 2021
Primary completion
Oct 22, 2025
Completion
Oct 22, 2025
Last update
Mar 18, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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