Evaluating ZN-c3 for patients with ovarian cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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 0103
  Houston, Texas, United States Recruiting

Study contacts

• Study coordinator: K-Group, Beta, Inc., a subsidiary of Zentalis Pharmaceuticals
• Email: medicalaffairs@zentalis.com
• Phone: 8582634333

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.