Tests azenosertib with chemotherapy or bevacizumab in ovarian cancer
Tests azenosertib with other cancer drugs in adults with ovarian cancer.
Plain-language title generated from the registry record
Registry title: A Study of Azenosertib (ZN-c3) in Patients With Ovarian Cancer
Key facts
- Where
- Adelaide, Melbourne, Nedlands, South Brisbane, and Sunshine Coast, AustraliaSee the 7 sites
- Phase
- Phase 1
Where in Australia
- AdelaideAdelaide, AustraliaNo longer taking part
- MelbourneMelbourne, AustraliaTaking people
- MelbourneMelbourne, AustraliaNo longer taking part
- NedlandsNedlands, AustraliaNo longer taking part
- South BrisbaneSouth Brisbane, AustraliaNo longer taking part
- Sunshine CoastSunshine Coast, AustraliaTaking people
- Sunshine CoastSunshine Coast, AustraliaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc
- Trial code
- NCT04516447EU 2025-524868-38-00
- Record updated
- 9 November 2026
- Original description
This is a Phase 1b open-label, multicenter study, evaluating the safety, tolerability, preliminary clinical activity, pharmacokinetics (PK), and pharmacodynamics of azenosertib (ZN-c3) in combination with other drugs.Read full original descriptionShow less
A Phase 1b Study of ZN-c3 in Combination With Chemotherapy or Bevacizumab in Subjects With Ovarian, Peritoneal, or Fallopian Tube Cancer
This is a Phase 1b open-label, multicenter study, evaluating the safety, tolerability, preliminary clinical activity, pharmacokinetics (PK), and pharmacodynamics of azenosertib (ZN-c3) in combination with other drugs.
Inclusion: For Part 1:; Histologically or cytologically confirmed FIGO Stage III/IV high-grade serous or endometrioid ovarian, fallopian tube, or peritoneal carcinoma; Subjects must have received 1 or 2 prior therapeutic regimens/lines of therapy in the advanced or metastatic setting. At least one regimen must have contained cisplatin or carboplatin; The disease must be platinum resistant (ie, the PFI must have been < 6 months). Platinum refractory disease (ie, PD during first-line platinum-based therapy) is allowed; For Part 2 Dose Escalation:; Prior therapy:; Subjects must have received 6 cycles of platinum-based doublet chemotherapy in the 1L or 2L setting as their most recent therapy; Response to prior platinum therapy:; In the 1L setting: Complete Response, Partial Response, or Stable Disease to platinum-based chemotherapy; In the 2L setting:; Progressive Disease >183 days after receiving the last dose of platinum chemotherapy in the 1L setting,; Complete Response, Partial Response, or Stable Disease to 2L platinum-based chemotherapy; Adequate hematologic, and organ function; For Part 2 Dose Expansion:; Subjects must have at least 4 cycles of platinum-based chemotherapy in 2L and have Complete Response, Partial Response, or Stable Disease; Subjects must have progressed while on a PARP inhibitor for 1L maintenance Additional protocol-defined inclusion criteria may apply.
Exclusion: A serious illness or medical condition(s); Subjects with active (uncontrolled, metastatic) second malignancies or requiring therapy; Additional protocol-defined exclusion criteria may apply; Histology of abdominal adenocarcinoma of unknown origin or diagnosis of a borderline ovarian tumor; Subjects with carcinosarcomas (even if there is a serous component).