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

Launched by K-GROUP, BETA, INC., A WHOLLY OWNED SUBSIDIARY OF ZENTALIS PHARMACEUTICALS, INC · Mar 22, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called ZN-c3 (azenosertib) for women who have recurrent or persistent uterine serous carcinoma (USC), which is a type of cancer that affects the uterus. It is a Phase 2 study, meaning the researchers are looking to see how well this treatment works and how safe it is for patients. The trial is currently recruiting women aged 18 and older who have already received certain cancer treatments but have not had success with them or cannot tolerate them.

To participate, women must have a confirmed diagnosis of USC and measurable disease, meaning their cancer can be tracked through scans. They should have also undergone specific treatments, like platinum-based chemotherapy and certain targeted therapies. Participants can expect regular visits for assessments and to receive the study medication, while the researchers will closely monitor their health and any side effects. It’s important for potential participants to know that there are certain health conditions and recent treatments that might prevent them from joining the study, so discussing eligibility with a healthcare provider is essential.

Gender

FEMALE

Eligibility 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.