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

NCT04814108 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: ZN-c3-004
• Study Type: interventional
• Target: 92
• Locations: 4 countries
• Sites: 56

Brief 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).

Conditions

Uterine Serous Carcinoma

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Frequency and severity of TEAEs

  To 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 ICR

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

  2 years

Secondary Outcomes (5)

• Objective Response Rate as defined by the revised RECIST v1.1. and assessed by ICR and the Investigator.

  2 years

• Duration of Response as defined by the revised RECIST v1.1. and assessed by ICR and the Investigator.

  2 years

• Progression Free Survival as defined by the revised RECIST v1.1. and assessed by ICR and the Investigator.

  2 years

• Clinical Benefit Rate as defined by the revised RECIST v1.1. and assessed by ICR and the Investigator.

  2 years

• Time To Response as defined by the revised RECIST v1.1. and assessed by ICR and the Investigator.

  2 years

Study Arms (1)

Azenosertib Single Agent

EXPERIMENTAL

Azenosertib (ZN-c3) taken orally with food

Drug: Azenosertib

Interventions

Azenosertib DRUG

Azenosertib is an investigational drug.

Also known as: ZN-c3

Azenosertib Single Agent

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

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

Study Sites (56)

Alaska Women's Cancer Care

Anchorage, Alaska, 99508, United States

Location

Honor Health

Phoenix, Arizona, 85016, United States

Location

Arizona Oncology Associates Wilmot HOPE

Tucson, Arizona, 85711, United States

Location

Banner University Medical Center Tucson

Tucson, Arizona, 85719, United States

Location

University of California Irvine Medical Center

Orange, California, 92868, United States

Location

University of California San Francisco at Mission Bay

San Francisco, California, 94158, United States

Location

Mount Sinai Medical Center

Miami Beach, Florida, 33140, United States

Location

Sarasota Memorial Hospital

Sarasota, Florida, 34239, United States

Location

University of South Florida

Tampa, Florida, 33606, United States

Location

Northside Hospital

Atlanta, Georgia, 30342, United States

Location

Georgia Cancer Center at Augusta University

Augusta, Georgia, 30912, United States

Location

Northwestern University

Evanston, Illinois, 60208, United States

Location

Maryland Oncology Hematology

Annapolis, Maryland, 21401, United States

Location

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

Oakland Medical Group

Detroit, Michigan, 48201, United States

Location

Corewell Health

Grand Rapids, Michigan, 49503, United States

Location

Revive Clinical Research

Sterling, Michigan, 48659, United States

Location

HCA Midwest Health Kansas City Research

Kansas City, Missouri, 64132, United States

Location

Center of Hope

Reno, Nevada, 89511, United States

Location

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08901, United States

Location

Optimum Clinical Research Group- Women's Oncology

Albuquerque, New Mexico, 87109, United States

Location

Westchester Medical Center

Hawthorne, New York, 10532, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45219, United States

Location

Oncology Hematology Care

Cincinnati, Ohio, 45242, United States

Location

Trihealth Cancer Institute

Cincinnati, Ohio, 45242, United States

Location

Ohio State University James Cancer Hospital

Columbus, Ohio, 43210, United States

Location

University of Oklahoma Peggy and Charles Stephenson Cancer Center

Oklahoma City, Oklahoma, 73104, United States

Location

Willamette Valley Cancer Institute

Eugene, Oregon, 97401, United States

Location

Providence Portland Medical Center

Portland, Oregon, 97213, United States

Location

Northwest Cancer Specialists

Portland, Oregon, 97227, United States

Location

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

Location

Ascension St. Thomas Midtown Hospital

Nashville, Tennessee, 37236, United States

Location

Texas Oncology Austin

Austin, Texas, 78705, United States

Location

Texas Oncology Fort Worth Cancer Center

Fort Worth, Texas, 76104, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Texas Oncology Gulf Coast

Houston, Texas, 77089, United States

Location

Texas Oncology San Antonio

San Antonio, Texas, 78240, United States

Location

University of Virginia Cancer Center

Charlottesville, Virginia, 22908, United States

Location

VCU Health System

Richmond, Virginia, 23298, United States

Location

Virginia Cancer Specialists

Warrenton, Virginia, 20186, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Concord Repatriation General Hospital

Concord, New South Wales, 2139, Australia

Location

Northern Cancer Institute

St Leonards, New South Wales, 2065, Australia

Location

Icon Cancer Centre- Chermside

Brisbane, Queensland, 4032, Australia

Location

Mater Cancer Care Centre, Mater Misericordiae Limited

Brisbane, Queensland, 4101, Australia

Location

Burnside War Memorial Hospital

Toorak Gardens, South Australia, 6065, Australia

Location

Cabrini Hospital Malvern

Malvern, Victoria, 3144, Australia

Location

Peter MacCallum Cancer Centre

Melbourne, Victoria, 3000, Australia

Location

Sir Charles Gairdner Hospital

Nedlands, Western Australia, 6009, Australia

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Chu de Quebec-Universite

Québec, Quebec, G1R 3S1, Canada

Location

LTD High Technology Hospital Medcenter

Batumi, Adjara, 6000, Georgia

Location

Rustavi Clinic

Rustavi, Kvemo Kartli, 3700, Georgia

Location

Acad. Fridon Todua Medical Center

Tbilisi, 0112, Georgia

Location

LTD Innova Medical Center

Tbilisi, 0144, Georgia

Location

LTD TIM-Tbilisi Innova of Medicine

Tbilisi, 0160, Georgia

Location

MeSH Terms

Conditions

Cystadenocarcinoma, Serous

Condition Hierarchy (Ancestors)

Cystadenocarcinoma; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Cystic, Mucinous, and Serous

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2021
• First Posted: March 24, 2021
• Study Start: July 28, 2021
• Primary Completion: October 22, 2025
• Study Completion: October 22, 2025
• Last Updated: March 18, 2026

Record last verified: 2026-03

Locations

US (41); CA (2); AU (8); GE (5)