Clinical Trial

A Phase 2 Open-Label, Multicenter Study to Evaluate Efficacy and Safety of ZN-c3 in Adult Women with Recurrent or Persistent Uterine Serous Carcinoma (ZN-c3-004 | GOG 3065)

MOA: ZN-c3 is a novel, selective and orally bioavailable small-molecular inhibitor of the WEE1 tyrosine kinase.

Key Eligibility:

• Histologically confirmed recurrent/persistent USC for which no other proven effective treatment options are available or any available SOC therapy was not tolerated or was refused by the subject
• Endometrial carcinoma of mixed histology with the serous component ≥10% of the tumor will be considered eligible
• Measurable disease per RECIST v1.1
• ECOG PS of ≤1
• Treatment with ≥1 prior platinum-based chemotherapy regimen for management of advanced/metastatic USC
• Major surgery <28 days; any chemotherapy <14 days/5 half-lives; radiation therapy <21 days (eligible if the radiation portal covered ≤5% of the bone marrow); autologous/allogeneic SCT <3 months excluded
• Prior treatment with a cell cycle checkpoint inhibitor/ZN-c3/any other WEE1 inhibitor excluded
• Brain metastases that require immediate treatment or are clinically/radiologically unstable
• Second malignancies/requiring therapy