A Study of Azenosertib (ZN-c3) in Patients With Ovarian Cancer

Recruiting now · Phase 1

Conditions studied: Solid Tumor, Epithelial Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer

In brief

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.

Key facts

Study ID

NCT04516447

Run by

K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc

People needed

172

Starts

2020-10-26

Expected to finish

2028-06-30

Last updated by the study team

2026-04-07

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Histology of abdominal adenocarcinoma of unknown origin or diagnosis of a borderline ovarian tumor.
• Subjects with carcinosarcomas (even if there is a serous component)
• A serious illness or medical condition(s)
• Subjects with active (uncontrolled, metastatic) second malignancies or requiring therapy.
• Additional protocol-defined exclusion criteria may apply

Where it is running

• Site 0264 — Aurora, Colorado, United States (enrolling)
• Site 0104 — Boston, Massachusetts, United States (enrolling)
• Site 0111 — St Louis, Missouri, United States (enrolling)
• Site 0173 — New York, New York, United States (enrolling)
• Site 0259 — Durham, North Carolina, United States (enrolling)
• Site 0191 — Providence, Rhode Island, United States (enrolling)
• Site 0103 — Houston, Texas, United States (enrolling)
• Site 2716 — Melbourne, Victoria, Australia (enrolling)
• Site 2706 — Melbourne, Victoria, Australia (enrolling)
• Site 2705 — Nedlands, Western Australia, Australia (enrolling)
• Site 2709 — Adelaide, South Australia, Australia
• Site 2901 — Busan, South Korea
• Site 2903 — Seoul, South Korea
• Site 2904 — Seoul, South Korea
• Site 1001 — Banja Luka, Bosnia and Herzegovina
• Site 1002 — Sarajevo, Bosnia and Herzegovina
• Site 1003 — Tuzla, Bosnia and Herzegovina
• Site 1202 — Panagyurishte, Bulgaria
• Site 1201 — Sofia, Bulgaria
• Site 1401 — Tbilisi, Georgia
• Site 0196 — Nashville, Tennessee, United States
• Site 1902 — Belgrade, Serbia
• Site 2707 — South Brisbane, Queensland, Australia
• Site 2708 — Sunshine Coast, Queensland, Australia

Full record on ClinicalTrials.gov

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