RecruitingOvarian Cancer
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
Eligible age
18+ yrs
Accepts
Women
Locations
7 states
Healthy volunteers
No
See if you qualify for this study
Answer a few quick questions about your location and health. Takes about a minute.
About this study
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.
Sponsor: K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc
You may qualify if…
- ✓ 1. Female age ≥ 18 years
- ✓ 2. High-grade serous epithelial ovarian, primary peritoneal, or fallopian tube cancer
- ✓ 3. Measurable disease per RECIST Version 1.1
- ✓ 4. Eastern Cooperative Oncology Group (ECOG) performance status score 0-1
- ✓ 5. 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
- ✓ 6. Prior Therapy:
- ✓ 1. Subject must have platinum-resistant disease
- ✓ 2. One to 3 prior lines or regimens are allowed (1 to 4 prior lines are permitted, if prior mirvetuximab)
You may not qualify if…
- ✕ 1. 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.
- ✕ 2. Subjects with primary platinum-refractory disease.
- ✕ 3. Prior therapy with azenosertib or any other WEE1 inhibitor, ATR inhibitor, CHK1/2 inhibitor, or (PKMYT1) inhibitor for PROC.
- ✕ 4. A serious illness or medical condition(s) including, but not limited to, the following:
- ✕ 1. Clinically or radiographically unstable brain metastases or leptomeningeal disease that requires immediate treatment. Subjects with asymptomatic brain metastases are eligible.
- ✕ 2. Acute kidney injury requiring intervention, or presence of indwelling urinary catheter or percutaneous nephrostomy.
- ✕ 3. 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.
- ✕ 4. 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.
Where it's recruiting
Arizona
Phoenix
California
Antioch · Beverly Hills · San Francisco · Torrance
New Jersey
Camden
Ohio
Columbus
Oregon
Portland
Pennsylvania
Philadelphia · Willow Grove
South Dakota
Sioux Falls
Source: ClinicalTrials.gov · NCT07546500 · last updated 2026-08-12