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

Recruiting now · Phase 3

Conditions studied: Ovarian Cancer

In brief

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.

Key facts

Study ID: NCT07546500
Run by: K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc
People needed: 420
Starts: 2026-04-17
Expected to finish: 2030-04-30
Last updated by the study team: 2026-07-17

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

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)
Prior bevacizumab treatment is required, if eligible per standard of care
Prior PARP inhibitor treatment is required if BRCA 1/2 mutation or HRD, if eligible per standard of care
Prior mirvetuximab treatment is required, if eligible per standard of care
Adequate hematologic and organ function during the screening period

You may not qualify if…

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:
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.
Active, uncontrolled infection. Subjects with an infection receiving treatment (antibiotic, antifungal, or antiviral) must have completed such treatment and the infection must be considered controlled/resolved (and afebrile) by the Investigator for at least 7 days before randomization
Myocardial impairment of any cause resulting in heart failure by New York Heart Association criteria (Class II, III or IV).
Medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results
Any of the following treatment interventions within the specified time frame before randomization:
Hospitalization within 14 days
Major surgery within 28 days
Any chemotherapy or targeted tumor therapy within 21 days or 5 half-lives (whichever is shorter)
Radiation therapy within 21 days
Autologous or allogeneic stem cell transplant within 3 months
Current use of any other investigational drug therapy < 28 days or 5 half-lives (whichever is shorter)
Inability to discontinue treatment with prescription or nonprescription drugs that are prohibited per protocol.
Inability to discontinue consumption of food and herbal supplements that are prohibited per protocol
Prior wide-field radiotherapy affecting ≥ 20% of the bone marrow.
Unresolved toxicity of Grade > 1 attributed to any prior therapies (excluding Grade ≤ 2 neuropathy, alopecia, or skin pigmentation).
Subjects who are immunocompromised or HIV-positive on highly active anti-retroviral therapy
Subjects with known active hepatitis B or hepatitis C infection
Individuals who are judged by the Investigator to be unsuitable as study subjects

Where it is running

Site 1201 — Seoul, South Korea (enrolling)
Site 1205 — Seoul, South Korea (enrolling)
Site 1202 — Seoul, South Korea (enrolling)
Site 0101 — Torrance, California, United States (enrolling)
Site 0108 — Columbus, Ohio, United States
Site 0105 — Portland, Oregon, United States
Site 0115 — San Francisco, California, United States
Site 0114 — Willow Grove, Pennsylvania, United States
Site 0111 — Camden, New Jersey, United States
Site 0112 — Sioux Falls, South Dakota, United States
Site 1101 — Randwick, New South Wales, Australia
Site 1102 — Adelaide, South Australia, Australia
Site 1103 — Nedlands, Australia
Site 3002 — Brussels, Belgium
Site 0204 — Montreal, Quebec, Canada
Site 0113 — Philadelphia, Pennsylvania, United States
Site 0201 — Toronto, Ontario, Canada
Site 0203 — Montreal, Quebec, Canada
Site 0202 — Sherbrooke, Quebec, Canada
Site 3508 — Besançon, France
Site 3502 — Brest, France
Site 3507 — Dijon, France
Site 3504 — Lyon, France
Site 3503 — Paris, France
Site 3001 — Leuven, Belgium

Full record on ClinicalTrials.gov

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