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

March 16, 2026 updated by: K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc

A Phase 2 Open-Label, Multicenter Study to Evaluate Efficacy and Safety of ZN-c3 in Adult Women With Recurrent or Persistent Uterine Serous Carcinoma

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
92

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

  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.

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?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Azenosertib Single Agent
Azenosertib (ZN-c3) taken orally with food
Drug: Azenosertib
Azenosertib is an investigational drug.
Other Names:
  • ZN-c3

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Objective Response Rate as defined by the revised RECIST v1.1 as assessed by ICR
Time Frame: 2 years
To investigate the antitumor activity of ZN-c3 in subjects with recurrent or persistent USC
2 years
Frequency and severity of TEAEs
Time Frame: 2 years
To determine the safety and tolerability of ZN-c3 in subjects with recurrent or persistent USC.
2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Objective Response Rate as defined by the revised RECIST v1.1. and assessed by ICR and the Investigator.
Time Frame: 2 years
To investigate the antitumor activity of ZN-c3 in subjects with recurrent or persistent USC at different doses/schedules
2 years
Duration of Response as defined by the revised RECIST v1.1. and assessed by ICR and the Investigator.
Time Frame: 2 years
To investigate the antitumor activity of ZN-c3 in subjects with recurrent or persistent USC at different doses/schedules
2 years
Progression Free Survival as defined by the revised RECIST v1.1. and assessed by ICR and the Investigator.
Time Frame: 2 years
To investigate the antitumor activity of ZN-c3 in subjects with recurrent or persistent USC at different doses/schedules
2 years
Clinical Benefit Rate as defined by the revised RECIST v1.1. and assessed by ICR and the Investigator.
Time Frame: 2 years
To investigate the antitumor activity of ZN-c3 in subjects with recurrent or persistent USC at different doses/schedules
2 years
Time To Response as defined by the revised RECIST v1.1. and assessed by ICR and the Investigator.
Time Frame: 2 years
To investigate the antitumor activity of ZN-c3 in subjects with recurrent or persistent USC at different doses/schedules
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Project Director, K-Group Beta (A wholly owned subsidiary of Zentalis Pharmaceuticals)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 28, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 22, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 22, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 18, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 22, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 24, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ZN-c3-004

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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