A Study of Azenosertib (ZN-c3) Versus Investigator's Choice Chemotherapy in Subjects With Platinu… (NCT07546500) | Clinical Trial Compass
Not Yet RecruitingPhase 3
A Study of Azenosertib (ZN-c3) Versus Investigator's Choice Chemotherapy in Subjects With Platinum-Resistant High-Grade Serous Ovarian, Primary Peritoneal, or Fallopian Tube Cancers Positive for Cyclin E1 Protein Expression
420 participantsStarted 2026-04-15
Plain-language summary
This is a randomized, Phase 3 trial designed to evaluate the efficacy and safety of azenosertib compared to Investigator's choice of chemotherapy in subjects with platinum-resistant ovarian cancer whose tumors are positive for cyclin E1 protein expression.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion criteria
✓. Female age ≥ 18 years
✓. High-grade serous epithelial ovarian, primary peritoneal, or fallopian tube cancer
✓. Measurable disease per RECIST Version 1.1
✓. Eastern Cooperative Oncology Group (ECOG) performance status score 0-1
✓. The subject's tumor tissue must be positive for cyclin E1 protein expression per the Sponsor's clinically validated cyclin E1 IHC investigational, in vitro diagnostic assay
✓. Prior Therapy:
✓. Subject must have platinum-resistant disease
✓. One to 3 prior lines or regimens are allowed (1 to 4 prior lines are permitted, if prior mirvetuximab)
Exclusion criteria
✕. History of another malignancy in the previous 2 years, unless cured by surgery alone and continuously disease-free. Exceptions include appropriately treated carcinoma in situ of the cervix, nonmelanoma skin carcinoma, Stage 1 uterine cancer, or other malignancies with an expected curative outcome.
✕. Subjects with primary platinum-refractory disease.
✕. Prior therapy with azenosertib or any other WEE1 inhibitor, ATR inhibitor, CHK1/2 inhibitor, or (PKMYT1) inhibitor for PROC.
✕. A serious illness or medical condition(s) including, but not limited to, the following:
What they're measuring
1
Progression free survival (PFS) per RECIST v1.1 as assessed by Investigator
Timeframe: Up to approximately 24 months from the enrollment of the last subject
Trial details
NCT IDNCT07546500
SponsorK-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc
✕. Clinically or radiographically unstable brain metastases or leptomeningeal disease that requires immediate treatment. Subjects with asymptomatic brain metastases are eligible.
✕. Acute kidney injury requiring intervention, or presence of indwelling urinary catheter or percutaneous nephrostomy.
✕. Significant gastrointestinal abnormalities, including an inability to take oral medication, requirement for IV alimentation, active peptic ulcer, chronic diarrhea or vomiting considered to be clinically significant in the judgment of the Investigator, or prior surgical procedures affecting absorption.
✕. Any evidence of small bowel obstruction as determined by air/fluid levels on computed tomography (CT) scan, recent hospitalization for small bowel obstruction within 3 months before randomization, or recurrent paracentesis or thoracentesis within 6 weeks before randomization.