A Study of ZN-c3 in Women With Recurrent or Persistent Uterine Serous Carcinoma
Trial Status: active
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).
Inclusion 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.
Additional locations may be listed on ClinicalTrials.gov for NCT04814108.
Locations matching your search criteria
United States
Arizona
Tucson
Banner University Medical Center - Tucson
Status: Active
Name Not AvailableIllinois
Chicago
Northwestern University
Status: Temporarily closed to accrual
Name Not AvailableMaryland
Baltimore
University of Maryland/Greenebaum Cancer Center
Status: Active
Contact: Nancy S. Tait
Phone: 410-328-3546
Email: ntait@umm.edu
New Jersey
New Brunswick
Rutgers Cancer Institute of New Jersey
Status: Active
Name Not AvailablePennsylvania
Philadelphia
Thomas Jefferson University Hospital
Status: Approved
Name Not AvailableTemple University Hospital
Status: Temporarily closed to accrual
Name Not AvailableWillow Grove
Asplundh Cancer Pavilion
Status: Approved
Name Not AvailableThis 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).
Trial PhasePhase II
Trial Typetreatment
Lead OrganizationK-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc
- Primary IDZN-c3-004
- Secondary IDsNCI-2021-11201
- ClinicalTrials.gov IDNCT04814108