Clinical Trial

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

MOA: Azenosertib is a small molecular inhibitor of the WEE1 tyrosine kinase.

Key Eligibility Criteria:

• Histologically or cytologically diagnosed high-grade serous OC/FP/PPC FFPE tumor tissue must be submitted for prescreening – only positive cyclin E1 protein status (IHC) is eligible
• Must have plt-resistant disease
  • Primary plt-refractory excluded
• Prior bevacizumab required if eligible
• Prior PARPi as maintenance required if BRCA1/2m or HRD
• Prior MIRV required if indicated
• Measurable disease per RECIST v1.1
• Prior tx with WEE1 inhibitor, ATR inhibitor, CHK1/2 inhibitor, PKMYT1
  inhibitor or CDK2 inhibitor are excluded
• Part 2b: 1-3 prior lines of systemic tx
  • Up to 4 prior lines of tx allowed if pt received MIRV
• Part 2c: 1-4 prior lines of tx AND
  • Weekly taxane regimen as monotherapy or in combination with
    another agent(s) in the PROC setting. Nab-paclitaxel is allowed