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Evaluating ZN-c3 for women with recurrent uterine serous carcinoma

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

Phase 2 Interventional K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc · NCT04814108

This study is testing a new treatment called ZN-c3 to see if it can help women with recurrent uterine serous carcinoma who have run out of other options.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment76 (estimated)
Ages18 Years and up
SexFemale
SponsorK-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc Industry-sponsored
Drugs / interventionschemotherapy, Radiation
Locations52 sites (Anchorage, Alaska and 51 other locations)
Trial IDNCT04814108 on ClinicalTrials.gov

What this trial studies

This Phase 2 open-label, multicenter study aims to assess the clinical activity and safety of ZN-c3 (azenosertib) in adult women diagnosed with recurrent or persistent uterine serous carcinoma (USC). Participants must have histologically confirmed USC for which no effective treatment options are available or have been intolerable. The study will involve administering ZN-c3 and monitoring its effects on the disease. The goal is to determine if this treatment can provide a viable option for patients facing limited alternatives.

Who should consider this trial

Good fit: Ideal candidates are women aged 18 and older with recurrent or persistent USC who have exhausted other treatment options.

Not a fit: Patients with carcinosarcomas or those who have not received prior necessary therapies for endometrial cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new therapeutic option for women with recurrent or persistent uterine serous carcinoma.

How similar studies have performed: While this approach is novel for this specific condition, similar studies evaluating targeted therapies in gynecological cancers have shown promising results.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Anchorage, Alaska and 51 other locations

+2 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Uterine Serous Carcinomauterusuterineendometrialendometriumserous carcinomawee1Wee-1
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.