Condition: Solid Tumor · Epithelial Ovarian Cancer · Fallopian Tube Cancer · Sponsor: K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc
Interested? Contact the study team ↓
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.
This description comes directly from the study's public registry record.
K-Group, Beta, Inc., a subsidiary of Zentalis Pharmaceuticals · 8582634333 · medicalaffairs@zentalis.com
There is no obligation to join — the study team can answer your questions about taking part.
Always discuss trial participation with your own doctor first.
INCLUSION CRITERIA: 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: 1. In the 1L setting: Complete Response, Partial Response, or Stable Disease to platinum-based chemotherapy. 2. In the 2L setting: 1. Progressive Disease \>183 days after receiving the last dose of platinum chemotherapy in the 1L setting, 2. 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 CRITERIA: * 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
Reproduced word-for-word from the public registry record — the study team can answer questions about it.
| Site 0264 | Aurora, Colorado, United States | Recruiting |
| Site 0104 | Boston, Massachusetts, United States | Recruiting |
| Site 0111 | St Louis, Missouri, United States | Recruiting |
| Site 0173 | New York, New York, United States | Recruiting |
| Site 0259 | Durham, North Carolina, United States | Recruiting |
| Site 0191 | Providence, Rhode Island, United States | Recruiting |
| Site 0196 | Nashville, Tennessee, United States | Completed |
| Site 0103 | Houston, Texas, United States | Recruiting |
| Site 2707 | South Brisbane, Queensland, Australia | Completed |
| Site 2708 | Sunshine Coast, Queensland, Australia | Completed |
| Site 2709 | Adelaide, South Australia, Australia | Completed |
| Site 2716 | Melbourne, Victoria, Australia | Recruiting |
+ 12 more locations — full list on the registry record.
This study lists sites in the areas below. Each link shows other recruiting studies near that city, from the public registry record.
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