Evaluating ZN-c3 for patients with ovarian cancer
A Phase 1b Study of ZN-c3 in Combination With Chemotherapy or Bevacizumab in Subjects With Ovarian, Peritoneal, or Fallopian Tube Cancer
This study is testing a new treatment called ZN-c3 combined with other chemotherapy drugs to see if it is safe and effective for people with advanced ovarian cancer.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 172 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc Industry-sponsored |
| Drugs / interventions | chemotherapy, bevacizumab |
| Locations | 24 sites (Aurora, Colorado and 23 other locations) |
| Trial ID | NCT04516447 on ClinicalTrials.gov |
What this trial studies
This Phase 1b open-label, multicenter study investigates the safety and tolerability of ZN-c3 in combination with other chemotherapy agents for patients with advanced ovarian cancer. The study aims to assess the preliminary clinical activity, pharmacokinetics, and pharmacodynamics of the treatment regimen. Eligible participants must have high-grade serous epithelial ovarian carcinoma or related conditions and have previously undergone one or two lines of therapy. The study will be conducted at multiple sites across the United States.
Who should consider this trial
Good fit: Ideal candidates include individuals with high-grade serous epithelial ovarian carcinoma who have received one or two prior lines of therapy.
Not a fit: Patients with low-grade tumors or those who have not received prior treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced ovarian cancer.
How similar studies have performed: Other studies have shown promise with similar combination therapies in treating ovarian cancer, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Aurora, Colorado and 23 other locations
- 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)
- Site 2706 — Melbourne, Victoria, Australia (Recruiting)
- Site 2705 — Nedlands, Western Australia, Australia (Recruiting)
- Site 1001 — Banja Luka, Bosnia and Herzegovina (Completed)
- Site 1002 — Sarajevo, Bosnia and Herzegovina (Completed)
- Site 1003 — Tuzla, Bosnia and Herzegovina (Completed)
- Site 1202 — Panagyurishte, Bulgaria (Completed)
- Site 1201 — Sofia, Bulgaria (Completed)
- Site 1401 — Tbilisi, Georgia (Completed)
- Site 1902 — Belgrade, Serbia (Completed)
- Site 2901 — Busan, South Korea (Completed)
- Site 2903 — Seoul, South Korea (Completed)
- Site 2904 — Seoul, South Korea (Completed)
Study contacts
- Study coordinator: K-Group, Beta, Inc., a subsidiary of Zentalis Pharmaceuticals
- Email: medicalaffairs@zentalis.com
- Phone: 8582634333
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.