Uterine Serous CarcinomaPhase 2NCT04814108
A Study of Azenosertib (ZN-c3) in Women With Recurrent or Persistent Uterine Serous Carcinoma
A Phase 2 study testing Azenosertib in people with Uterine Serous Carcinoma, run by K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc at 56 sites in 4 countries.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Uterine Serous Carcinoma
- What is being tested?
- Azenosertib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 56 sitesin 4 countries
- Study dates
- 28 Jul 2021to 22 Oct 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 10Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
56 sites in 4 countries.
56 sites in 4 countries
United States41 sites
Optimum Clinical Research Group- Women's Oncology
Albuquerque, New Mexico, 87109
Alaska Women's Cancer Care
Anchorage, Alaska, 99508
Maryland Oncology Hematology
Annapolis, Maryland, 21401
Northside Hospital
Atlanta, Georgia, 30342
Georgia Cancer Center at Augusta University
Augusta, Georgia, 30912
Texas Oncology Austin
Austin, Texas, 78705
University of Maryland Medical Center
Baltimore, Maryland, 21201
University of Virginia Cancer Center
Charlottesville, Virginia, 22908
University of Cincinnati
Cincinnati, Ohio, 45219
Oncology Hematology Care
Cincinnati, Ohio, 45242
Trihealth Cancer Institute
Cincinnati, Ohio, 45242
Ohio State University James Cancer Hospital
Columbus, Ohio, 43210
Oakland Medical Group
Detroit, Michigan, 48201
Willamette Valley Cancer Institute
Eugene, Oregon, 97401
Northwestern University
Evanston, Illinois, 60208
Texas Oncology Fort Worth Cancer Center
Fort Worth, Texas, 76104
Corewell Health
Grand Rapids, Michigan, 49503
Westchester Medical Center
Hawthorne, New York, 10532
MD Anderson Cancer Center
Houston, Texas, 77030
Texas Oncology Gulf Coast
Houston, Texas, 77089
HCA Midwest Health Kansas City Research
Kansas City, Missouri, 64132
Mount Sinai Medical Center
Miami Beach, Florida, 33140
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Ascension St. Thomas Midtown Hospital
Nashville, Tennessee, 37236
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
University of Oklahoma Peggy and Charles Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104
University of California Irvine Medical Center
Orange, California, 92868
Temple University Hospital
Philadelphia, Pennsylvania, 19140
Honor Health
Phoenix, Arizona, 85016
Providence Portland Medical Center
Portland, Oregon, 97213
Northwest Cancer Specialists
Portland, Oregon, 97227
Center of Hope
Reno, Nevada, 89511
VCU Health System
Richmond, Virginia, 23298
Texas Oncology San Antonio
San Antonio, Texas, 78240
University of California San Francisco at Mission Bay
San Francisco, California, 94158
Sarasota Memorial Hospital
Sarasota, Florida, 34239
Revive Clinical Research
Sterling, Michigan, 48659
University of South Florida
Tampa, Florida, 33606
Arizona Oncology Associates Wilmot HOPE
Tucson, Arizona, 85711
Banner University Medical Center Tucson
Tucson, Arizona, 85719
Virginia Cancer Specialists
Warrenton, Virginia, 20186
Australia8 sites
Icon Cancer Centre- Chermside
Brisbane, Queensland, 4032
Mater Cancer Care Centre, Mater Misericordiae Limited
Brisbane, Queensland, 4101
Concord Repatriation General Hospital
Concord, New South Wales, 2139
Cabrini Hospital Malvern
Malvern, Victoria, 3144
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000
Sir Charles Gairdner Hospital
Nedlands, Western Australia, 6009
Northern Cancer Institute
St Leonards, New South Wales, 2065
Burnside War Memorial Hospital
Toorak Gardens, South Australia, 6065
Georgia5 sites
LTD High Technology Hospital Medcenter
Batumi, Adjara, 6000
Rustavi Clinic
Rustavi, Kvemo Kartli, 3700
Acad. Fridon Todua Medical Center
Tbilisi, 0112
LTD Innova Medical Center
Tbilisi, 0144
LTD TIM-Tbilisi Innova of Medicine
Tbilisi, 0160
Canada2 sites
Chu de Quebec-Universite
Québec, Quebec, G1R 3S1
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
About this study
Official title: 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).
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).
- Conditions
- Uterine Serous Carcinoma
- Being tested
- Azenosertib
- Keywords
- uterus, uterine, endometrial, endometrium, serous carcinoma, wee1, Wee-1, usc, Uterine Serous Carcinoma, serous
- Medical subject headings
- Cystadenocarcinoma, Serous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AzenosertibDrug
Also called ZN-c3
Azenosertib is an investigational drug.
| Study group | Role | What they receive |
|---|---|---|
| Azenosertib Single Agent | Experimental | Azenosertib (ZN-c3) taken orally with food Receives: Drug: Azenosertib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency and severity of TEAEs
To determine the safety and tolerability of ZN-c3 in subjects with recurrent or persistent USC.
Measured: 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
Measured: 2 years
Secondary outcomes (5)
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
Measured: 2 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/schedules
Measured: 2 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/schedules
Measured: 2 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/schedules
Measured: 2 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/schedules
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2021
- Study start28 Jul 2021
- Primary completion22 Oct 2025
- Study completion22 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine Serous CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04814108
- Sponsor's protocol ID
- ZN-c3-004
- Status last verified
- Mar 2026
- First submitted
- 18 Mar 2021
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04814108
- Acronym / sponsor ID
- ZN-c3-004
- Conditions
- Uterine Serous Carcinoma
- Keywords
- uterus, uterine, endometrial, endometrium, serous carcinoma, wee1, Wee-1, usc
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- 28 Jul 2021 (actual)
- Primary completion
- 22 Oct 2025 (actual)
- Study completion
- 22 Oct 2025 (actual)
- First posted
- 24 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Azenosertib Single Agent | Experimental | Drug: AzenosertibAzenosertib (ZN-c3) taken orally with food |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
- Measurable disease per RECIST Guideline Version 1.1
- Required prior therapy for endometrial cancer:
- Adequate hematologic and organ function
Key exclusion criteria (8 listed)
- Any of the following treatment interventions within the specified time frame prior to C1D1:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AzenosertibAlso: ZN-c3Azenosertib is an investigational drug. | Drug | Azenosertib Single Agent |
Primary outcome
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.
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
5 secondary outcomes
Objective Response Rate as defined by the revised RECIST v1.1. and assessed by ICR and the Investigator.
Time frame: 2 years
Duration of Response as defined by the revised RECIST v1.1. and assessed by ICR and the Investigator.
Time frame: 2 years
Progression Free Survival as defined by the revised RECIST v1.1. and assessed by ICR and the Investigator.
Time frame: 2 years
Clinical Benefit Rate as defined by the revised RECIST v1.1. and assessed by ICR and the Investigator.
Time frame: 2 years
Time To Response as defined by the revised RECIST v1.1. and assessed by ICR and the Investigator.
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
56 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Azenosertib in people with Uterine Serous Carcinoma, run by K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc at 56 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 56 sites in United States, Australia, Georgia, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency and severity of TEAEs (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.