A Study of Azenosertib (ZN-c3) Versus Investigator's Choice Chemotherapy in Subjects With
This is a randomized, Phase 3 trial designed to evaluate the efficacy and safety of azenosertib compared to Investigator's choice of chemotherapy in subjects with platinum-resistant ovarian cancer whose tumors are positive for cyclin E1 protein expression.
| Condition(s) | Ovarian Cancer |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| Summary | This is a randomized, Phase 3 trial designed to evaluate the efficacy and safety of azenosertib compared to Investigator's choice of chemotherapy in subjects with platinum-resistant ovarian cancer whose tumors are positive for cyclin E1 protein expression. |
| Who can participate | Inclusion Criteria: 1. Female age ≥ 18 years 2. High-grade serous epithelial ovarian, primary peritoneal, or fallopian tube cancer 3. Measurable disease per RECIST Version 1.1 4. Eastern Cooperative Oncology Group (ECOG) performance status score 0-1 5. The subject's tumor tissue must be positive for cyclin E1 protein expression per the Sponsor's clinically validated cyclin E1 IHC investigational, in vitro diagnostic assay 6. Prior Therapy: 1. Subject must have platinum-resistant disease 2. One to 3 prior lines or regimens are allowed (1 to 4 prior lines are permitted, if prior mirvetuximab) 3. Prior bevacizumab treatment is required, if eligible per standard of care 4. Prior PARP inhibitor treatment is required if BRCA 1/2 mutation or HRD, if eligible per standard of care 5. Prior mirvetux |
| Ages | 18 Years |
| Sex | Female |
| Lead sponsor | K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc |
| Locations | Phoenix, Arizona, United States; Antioch, California, United States; San Francisco, California, United States; Torrance, California, United States; Camden, New Jersey, United States; Columbus, Ohio, United States (+52 more sites) |
| Start date | 2026-04-17 |
| NCT ID | NCT07546500 |
| Official listing | https://clinicaltrials.gov/study/NCT07546500 |