NCT04516447 · K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc
A Study of Azenosertib (ZN-c3) in Patients With Ovarian Cancer
(MUIR)
What this study is about
This is a Phase 1b where both patients and doctors know the treatment given, conducted at multiple hospitals study, evaluating the safety, tolerability, preliminary clinical activity, how the drug moves through the body (PK), and how the drug affects the body of azenosertib (ZN-c3) in combination with other drugs.
View original scientific 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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:
- 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 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
- Aurora, Colorado
- Boston, Massachusetts
- St Louis, Missouri
- New York, New York
- Durham, North Carolina
- Providence, Rhode Island
- Nashville, Tennessee
- Houston, Texas
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 7, 2026 · Source of record for eligibility and locations