Status:
RECRUITING
A Study of ZN-c3 in Women With Recurrent or Persistent Uterine Serous Carcinoma
Lead Sponsor:
K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc
Conditions:
Uterine Serous Carcinoma
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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).
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 ca...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA
- 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
- EXCLUSION CRITERIA
- 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.
Exclusion
Key Trial Info
Start Date :
July 28 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2025
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT04814108
Start Date
July 28 2021
End Date
May 31 2025
Last Update
November 21 2024
Active Locations (52)
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1
Alaska Women's Cancer Care
Anchorage, Alaska, United States, 99508
2
Honor Health
Phoenix, Arizona, United States, 85016
3
Arizona Oncology Associates Wilmot HOPE
Tucson, Arizona, United States, 85711
4
University of California Irvine Medical Center
Orange, California, United States, 92868