A Study of Azenosertib (ZN-c3) in Subjects With Platinum-Resistant High-Grade Serous Ovarian, Fallopian Tube or Primary Peritoneal Cancer
Gynecologic Cancers
Primary Peritoneal Cancer
Unknown Primary
18 Years and older, Male and Female
ZN-c3-005 (primary)
NCI-2022-03875
Summary
This is a multi-part Phase 2 study to evaluate the efficacy and safety of azenosertib
(ZN-c3) in subjects with Platinum-Resistant, High-Grade Serous Ovarian, Fallopian Tube,
or Primary Peritoneal Cancer. Part 2 of the study will be conducted in subjects whose
tumors are Cyclin E1 positive as determined by central review using the Sponsor's
investigational clinical trial assay.
Objectives
A Phase 2 study to evaluate the efficacy and safety of azenossertib (ZN-c3) in subjects
with Platinum-Resistant, High-Grade Serous Ovarian, Fallopian Tube, or Primary Peritoneal
Cancer. Azenosertib is a selective and orally bioavailable inhibitor of WEE1. By
inhibiting WEE1, azenosertib enables cell cycle progression, despite high levels of DNA
damage, thereby resulting in the accumulation of DNA damage leading to mitotic
catastrophe and cancer cell death.
The study consists of two parts:
Part 1: All comers, no biomarker status required (completed enrollment)
Part 2: Cyclin E1 positive protein expression required
Eligibility
- Age =18 years
- High-grade serous ovarian, fallopian tube or primary peritoneal cancer
- Tumor testing (archival acceptable) confirms a positive Cyclin E1 protein status result determined by IHC using the Sponsor's investigational clinical trial assay
- Prior therapy:
- Subjects must have platinum-resistant disease
- One to 3 prior lines or regimens are allowed (1 to 4 prior lines are permitted, if prior mirvetuximab)
- Prior bevacizumab treatment is required, if eligible per standard of care
- Prior PARP inhibitor treatment is required if BRCA 1/2 mutation or HRD, if eligible per standard of care
- Prior mirvetuximab treatment is required, if eligible per standard of care
- Measurable disease per RECIST Version 1.1.
- Adequate hematologic and organ function, as defined in protocol
- ECOG 0-1
Treatment Sites in Georgia
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