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 (ZN-c3-005/GOG-3066/DENALI)

Trial summary:

This is a Phase 2 open-label, multicenter study to evaluate the clinical activity, safety, pharmacokinetics (PK), and biomarker profile of ZN-c3 in subjects with High-Grade Serous Ovarian, Fallopian Tube, Or Primary Peritoneal Cancer.

Receptor status / problem studied:

Inclusion criteria

1) Age ≥18 years at the time of informed consent.

2) Histologically or cytologically confirmed recurrent, high-grade serous ovarian, fallopian tube, or primary peritoneal cancer.

3) Prior therapy:
|— a) Subjects must have platinum-resistant disease.
|— b) Documented progressive disease ≤6 months.
|— c) One to 4 prior lines or regimens are allowed (1 to 5 in 1b).
|— d) Prior bevacizumab treatment is required (except where not standard of care treatment).

4) Subjects must have at least one measurable lesion as defined by RECIST Guideline Version 1.1.

5) Performance Status: Eastern Cooperative Oncology Group (ECOG) score of ≤1.

6) Adequate hematologic and organ function.

Exclusion criteria

1) Any of the following treatment interventions within the specified time frame prior to C1D1:
|— a) Major surgery within 28 days (any surgical incision should be fully healed prior to study drug administration);
|— b) Any chemotherapy or targeted tumor therapy within 14 days or 5 half-lives (whichever is shorter);
|— c) Radiation therapy within 21 days; however, if the radiation portal covered ≤5% of the bone marrow, the subject is eligible irrespective of the end date of radiotherapy.
|— d) Autologous or allogeneic stem cell transplant within 3 months.
|— e) Current use of any other investigational drug therapy <28 days or 5 half-lives (whichever is shorter).
|— f) Inability to discontinue treatment prescription or non-prescription drugs, or to discontinue consumption of food and herbal supplements, that are strong/ and moderate CYP3A4 inhibitors and inducers, or P-gp inhibitors at least 14 days prior to C1D1.

2) Prior therapy with ZN-c3 or any other WEE1 inhibitor, ATR inhibitor, or CHK1/2 inhibitor.

3) Unresolved toxicity of Grade >1 attributed to any prior therapies (excluding Grade ≤2 neuropathy, alopecia or skin pigmentation).

4) Subjects with active (uncontrolled, metastatic) second malignancies or requiring therapy.

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Open for recruitment

Trial Title



Ovarian cancer

Type of trial


Type of treatement

Medical Oncology





Principal Investigator
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