Zn-c3-005: A Phase 2 Open-Label, Multicenter Study to Evaluate Efficacy and Safety of ZN-c3 Subjects With High-Grade Serous Ovarian, Fallopian Tube, Or Primary Peritoneal Cancer
Enrolling By Invitation
100 years and younger
Female
Phase
2
Brief description of study
A Phase 2 study to evaluate the clinical activity, safety, and potentially predictive biomarker profile of ZN-c3 in subjects with High-Grade Serous Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Detailed description of study
This study is Enrolling by Invitation at Lancaster General Hospital - ABBCI
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: In clinic, in person
-
Age: - 100 Years
-
Gender: Female
Inclusion Criteria:
- Age 18 years or older
- High-grade serous ovarian cancer
- Prior therapy: Subjects must have platinum-resistant disease, one to 4 prior lines or regimens are allowed (1 to 5 prior lines are permitted in part 1b), and prior bevacizumab treatment is required
- Measurable disease per RECIST Version 1.1.
- 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
- 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 technology (CT) scan, recent hospitalization for bowel obstruction within 3 months prior to C1 D1, or recurrent paracentesis or thoracentesis within 6 weeks prior to C1 D1
Updated on
01 Aug 2024.
Study ID: ZN-c3-005
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