RECRUITING
Phase 2
ClinicalTrials.gov
A Study of Azenosertib (ZN-c3) in Subjects With Platinum-Resistant High-Grade Serous Ovarian, Fallopian Tube or Primary Peritoneal Cancer
Sponsor: K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc • ClinicalTrials.gov ID: NCT05128825
Registry updated: 2026-09-29
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This is a multi-part Phase 2 study to evaluate the efficacy and safety of azenosertib (ZN-c3) in subjects with Platinum-Resistant, High-Grade Serous Ovarian, Fallopian Tube, or Primary Peritoneal Cancer. Part 2 of the study will be conducted in subjects whose tumors are Cyclin E1 positive as determined by central review using the Sponsor's investigational clinical trial assay.
Interventions
-
azenosertib
(Drug)
Azenosertib (ZN-c3) will be administered orally.
Eligibility criteria
Inclusion Criteria:
1. Age ≥18 years
2. High-grade serous ovarian, fallopian tube or primary peritoneal cancer
3. Tumor testing (archival acceptable) confirms a positive Cyclin E1 protein status result determined by IHC using the Sponsor's investigational clinical trial assay
4. Prior therapy:
1. Subjects must have platinum-resistant disease
2. Part 2c: Subjects with PROC may have 1 to 4 prior lines or regimens. Prior treatment in this cohort includes a weekly taxane regimen, either as single agent or in combination, per protocol
3. Prior bevacizumab treatment is required, if eligible per standard of care
4. Prior PARP inhibitor treatment is required if BRCA 1/2 mutation or HRD, if eligible per standard of care
5. Prior mirvetuximab treatment is required, if eligible per standard of care
5. Measurable disease per RECIST Version 1.1.
6. Adequate hematologic and organ function, as defined in protocol
7. ECOG 0-1
Exclusion Criteria:
1. Primary platinum-refractory disease
2. Subjects with endometrioid, clear cell, mucinous, or sarcomatous histology, mixed tumors containing any of the above histologies, low-grade, borderline, or other ovarian tumors
3. Any of the following treatment interventions within the specified time frame prior to C1D1:
1. Major surgery within 28 days
2. Hospitalization within 14 days
3. Any chemotherapy or targeted tumor therapy within 21 days or 5 half-lives (whichever is shorter);
4. Radiation therapy within 21 days;
5. Autologous or allogeneic stem cell transplant within 3 months.
6. Current use of any other investigational drug therapy \<28 days or 5 half-lives (whichever is shorter).
7. Inability to discontinue treatment prescription or non-prescription drugs, or to discontinue consumption of food and herbal supplements that are strong or moderate CYP3A inhibitors and inducers or P-gp inhibitors at least 14 days prior to C1D1.
4. Prior therapy with ZN-c3 or any other WEE1 inhibitor, ATR inhibitor, PKMYT1 inhibitor, or CHK1/2 inhibitor.
5. A serious illness or medical condition(s) including, but not limited to:
1. Clinically or radiographically unstable brain metastases or leptomeningeal disease that requires immediate treatment. Subjects with asymptomatic brain metastases are eligible.
2. Myocardial impairment resulting in heart failure (NYHA Class II-IV)
3. Severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase risk associated with study participation or may interfere with interpretation of study results
4. Acute kidney injury requiring intervention or intravenous fluid in the last 14 days or presence of indwelling urinary catheter or percutaneous nephrostomy.
5. Significant gastrointestinal abnormalities, including an inability to take oral medication, requirement for intravenous 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.
6. 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 C1D1
7. Any evidence of bowel obstruction as determined by air/fluid levels on computed tomography (CT scan, recent hospitalization for small bowel obstruction within 3 months prior to C1D1, or recurrent paracentesis or thoracentesis within 6 weeks prior to C1D1.
6. Unresolved toxicity of Grade \>1 attributed to any prior therapies (excluding Grade ≤2 neuropathy, alopecia, or skin pigmentation).
7. Pregnant or lactating female subject or female subject of childbearing potential who has a positive serum pregnancy test within 14 days prior to C1D1.
8. 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, non-melanoma skin carcinoma, Stage 1 uterine cancer, or other malignancies with an expected curative outcome.
9. Subjects who are known to be immunocompromised or HIV-positive on highly active anti-retroviral therapy.
10. Subjects with known active hepatitis B or hepatitis C infection.
11. Individuals who are judged by the Investigator to be unsuitable as study subjects.
12. Subjects who had prior wide-field radiotherapy affecting ≥ 20% of the bone marrow.
Conditions
High-Grade Serous Ovarian, Fallopian Tube or Primary Peritoneal Cancer
Locations
- Site 0170-USA Mitchell Cancer Institute — Mobile, Alabama, United States
- Site 0143 - HonorHealth — Phoenix, Arizona, United States
- Site 0102 - University of Arizona Cancer Center — Tucson, Arizona, United States
- Site 0258 - UC San Diego Moores Cancer Center — La Jolla, California, United States
- Site 0287 - Ridley Tree Cancer Center — Santa Barbara, California, United States
- Site 0135 - Rocky Mountain Cancer Centers — Lone Tree, Colorado, United States
- Site 0158 - Hartford HealthCare — Hartford, Connecticut, United States
- Site 0241 - Florida Cancer Specialist - North — Altamonte Springs, Florida, United States
- Site 0173 - Mount Sinai Medical Center — Miami Beach, Florida, United States
- Site 0308 - Advent Health — Orlando, Florida, United States
- Site 0239 - Florida Cancer Specialists - East — Wellington, Florida, United States
- Site 0108 - Emory University Hospital — Atlanta, Georgia, United States
- Site 0236 - Memorial Health — Savannah, Georgia, United States
- Site 0324 - Illinois Cancer Specialists — Niles, Illinois, United States
- Site 0284 - Community Cancer Center North — Indianapolis, Indiana, United States
- Site 0217 - St Vincent Hospital and Health Care Centers — Indianapolis, Indiana, United States
- Site 0251 - Norton Cancer Institute — Louisville, Kentucky, United States
- Site 0146 - Maryland Oncology Hematology, PA — Rockville, Maryland, United States
- Site 0221 - Tufts Medical Center - PPDS — Boston, Massachusetts, United States
- Site 0104 - Dana Farber Cancer Institute — Boston, Massachusetts, United States
- Site 0307 - Lahey Hospital and Medical Center — Burlington, Massachusetts, United States
- Site 0263 - Baystate Medical Center — Springfield, Massachusetts, United States
- Site 0101 - Barbara Ann Karmanos Cancer Institute — Detroit, Michigan, United States
- Site 0228 - Corewell Health Medical Group West — Grand Rapids, Michigan, United States
- Site 0288 - Minnesota Oncology Hematology - Maplewood — Maplewood, Minnesota, United States
- Site 0226 - CoxHealth — Springfield, Missouri, United States
- Site 0317 - Nebraska Methodist Hospital — Omaha, Nebraska, United States
- Site 0213 - Center of Hope — Reno, Nevada, United States
- Site 0231 - Northwell Health Cancer Institute — Manhasset, New York, United States
- Site 0126 - Wilmot Cancer Center — Rochester, New York, United States
- Site 0259 - Duke Cancer Center — Durham, North Carolina, United States
- Site 0147 - Trihealth Cancer Institute - Harold and Eugen — Cincinnati, Ohio, United States
- Site 0243 - Mark H Zangmeister Cancer Center — Columbus, Ohio, United States
- Site 0214-Ohio State University Comprehensive Cancer Center — Hilliard, Ohio, United States
- Site 0316 - Willamette Valley Cancer Institute/Oncology Associates of Oregon — Eugene, Oregon, United States
- Site 0232 - University of Pennsylvania — Philadelphia, Pennsylvania, United States
- Site 0178 - Thomas Jefferson University — Philadelphia, Pennsylvania, United States
- Site 0277 - Alliance Cancer Specialist, PC — Wynnewood, Pennsylvania, United States
- Site 0132 - Avera Cancer Institute — Sioux Falls, South Dakota, United States
- Site 0103 - University of Texas MD Anderson Cancer Center — Houston, Texas, United States
- Site 0203 - Texas Oncology — Tyler, Texas, United States
- Site 0295 - Virginia Oncology Associates — Chesapeake, Virginia, United States
- Site 0322 - Inova Schar Cancer Institute — Fairfax, Virginia, United States
- Site 2715 - Icon Cancer Centre - Chermside — Chermside, Queensland, Australia
- Site 2707 - Mater Brisbane — South Brisbane, Queensland, Australia
- Site 2709 - Cancer Research SA — Adelaide, South Australia, Australia
- Site 2702 - Burnside War Memorial Hospital - The Brian Fricker Oncology Centre — Toorak Gardens, South Australia, Australia
- Site 2716 - Epworth Healthcare Freemasons — East Melbourne, Victoria, Australia
- Site 2701 - Sir Charles Gairdner Hospital — Nedlands, Western Australia, Australia
- Site 2717 - St John of God Hospital Subiaco — Subiaco, Western Australia, Australia
- Site 3102 - Cliniques Universitaires Saint-Luc — Brussels, Brussels Capital, Belgium
- Site 3105 - UZ Leuven — Leuven, Vlaams Brabant, Belgium
- Site 3616 - Centre Antoine Lacassagne — Nice, Alpes-Maritimes, France
- Site 3601 - Centre Georges François Leclerc — Dijon, Côte-d'Or, France
- Site 3613 - CHRU Besancon - Hopital Jean Minjoz — Besançon, Doubs, France
- Site 3617 - CHU de Brest - Hôpital La Cavale Blanche — Brest, Finistere, France
- Site 3603 - Institut Claudius Regaud — Toulouse, Haute-Garonne, France
- Site 3602 - Centre Oscar Lambret — Lille, Nord, France
- Site 3615 - Hôpital Cochin Port-Royal AP-HP — Paris, Paris, France
- Site 3614 - Institut de Cancerologie de l'oust — Saint-Herblain, Pays de la Loire Region, France
- Site 3608 - Hospices Civils de Lyon - Hôpital Lyon Sud — Pierre-Bénite, Rhône, France
- Site 3619 - Centre Léon Bérard — Lyon, France
- Site 3620 - CHU de Strasbourg - Hopital de Hautepierre — Strasbourg, France
- Site 3604 - Institut Gustave Roussy — Villejuif, France
- Site 3302 - Istituto Nazionale Tumori IRCCS Fondazione Giovanni Pascale — Naples, Campania, Italy
- Site 3308 - Azienda Ospedaliero Universitaria Di Modena Policlinico — Modena, Emilia-Romagna, Italy
- Site 3312 - Centro di Riferimento Oncologico — Aviano, Friuli Venezia Giulia, Italy
- Site 3304 - Fondazione Policlinico Universitario A Gemelli — Rome, Lazio, Italy
- Site 3305 - Istituto Europeo di Oncologia — Milan, Lombardy, Italy
- Site 3307 - Ospedale San Raffaele S.r.l. — Milan, Milano, Italy
- Site 3311 - Azienda Ospedaliera Universitaria Integrata Di Verona — Verona, Veneto, Italy
- Site 3303 - Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi-Via Massarenti — Bologna, Italy
- Site 2405 - Centrum Badan Klinicznych JCI — Krakow, Lesser Poland Voivodeship, Poland
- Site 2419 - Bialostockie Centrum Onkologii im. Marii Sklodowskiej-Curie w Bialymstoku — Bialystok, Podlaskie Voivodeship, Poland
- Site 2421 - Szpitale Pomorskie Sp. z o. o. — Gdynia, Pomeranian Voivodeship, Poland
- Site 2908 - National Cancer Center — Goyang-si, Gyeonggi-do, South Korea
- Site 2905 - Seoul National University Hospital — Seoul, South Korea
- Site 2909 - Severance Hospital Yonsei University Health System — Seoul, South Korea
- Site 2904 - Asan Medical Center — Seoul, South Korea
- Site 2906 - Gangnam Severance Hospital, Yonsei University Health System — Seoul, South Korea
- Site 2907 - Samsung Medical Center — Seoul, South Korea
- Site 3511 - Instituto de Investigacion Oncologica Vall d'Hebron — Barcelona, Barcelona, Spain
- Site 3517 - Clinica Universidad de Navarra — Madrid, Madrid, Spain
- Site 3516 - Hospital Universitario Virgen de La Arrixaca — Murcia, Murcia, Spain
- Site 3501 - Hospital Clinico Universitario de Valencia — Valencia, Valencia, Spain
- Site 3502 - Hospital Universitario La Paz — Madrid, Spain
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Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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