A PHASE 2 OPEN-LABEL, MULTICENTER STUDY TO EVALUATE EFFICACY AND SAFETY OF ZN‑c3 IN SUBJECTS WITH HIGH-GRADE SEROUS OVARIAN, FALLOPIAN TUBE, OR PRIMARY PERITONEAL CANCER
Trial Description
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
Eligibility Requirements
Inclusion Criteria:
1. Age ≥18 years
2. High-grade serous ovarian cancer
3. Prior therapy:
1. Subjects must have platinum-resistant disease
2. One to 4 prior lines or regimens are allowed (1 to 5 prior lines are permitted
in part 1b)
3. Prior bevacizumab treatment is required
4. Measurable disease per RECIST Version 1.1.
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.
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 C1 D1, or recurrent paracentesis or thoracentesis within 6 weeks prior to
C1 D1.