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

Completed · Phase 2

Conditions studied: Uterine Serous Carcinoma

In brief

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).

Key facts

Study ID

NCT04814108

Run by

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

People needed

92

Starts

2021-07-28

Expected to finish

2025-10-22

Last updated by the study team

2026-03-18

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Honor Health — Phoenix, Arizona, United States
• Arizona Oncology Associates Wilmot HOPE — Tucson, Arizona, United States
• Banner University Medical Center Tucson — Tucson, Arizona, United States
• University of California Irvine Medical Center — Orange, California, United States
• University of California San Francisco at Mission Bay — San Francisco, California, United States
• Mount Sinai Medical Center — Miami Beach, Florida, United States
• Sarasota Memorial Hospital — Sarasota, Florida, United States
• University of South Florida — Tampa, Florida, United States
• Northside Hospital — Atlanta, Georgia, United States
• Georgia Cancer Center at Augusta University — Augusta, Georgia, United States
• Northwestern University — Evanston, Illinois, United States
• Maryland Oncology Hematology — Annapolis, Maryland, United States
• University of Maryland Medical Center — Baltimore, Maryland, United States
• Oakland Medical Group — Detroit, Michigan, United States
• Corewell Health — Grand Rapids, Michigan, United States
• Revive Clinical Research — Sterling, Michigan, United States
• HCA Midwest Health Kansas City Research — Kansas City, Missouri, United States
• Center of Hope — Reno, Nevada, United States
• Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey, United States
• Optimum Clinical Research Group- Women's Oncology — Albuquerque, New Mexico, United States
• Westchester Medical Center — Hawthorne, New York, United States
• University of Cincinnati — Cincinnati, Ohio, United States
• Oncology Hematology Care — Cincinnati, Ohio, United States
• Trihealth Cancer Institute — Cincinnati, Ohio, United States
• Alaska Women's Cancer Care — Anchorage, Alaska, United States

Full record on ClinicalTrials.gov

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