A Study of Azenosertib (ZN-c3) in Subjects With Platinum-Resistant High-Grade Serous Ovarian, Fallopian Tube or Primary Peritoneal Cancer
NCT ID: NCT05128825
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
170 participants
INTERVENTIONAL
2022-02-17
2027-06-30
Brief Summary
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Detailed Description
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The study consists of two parts:
Part 1: All comers, no biomarker status required (completed enrollment)
Part 2: Cyclin E1 positive protein expression required
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Part 2b
Azenosertib at the dose selected in Part 2a administered on a 5 days on, 2 days off intermittent schedule
azenosertib
Azenosertib (ZN-c3) will be administered orally.
Part 2a: Arm 1
Azenosertib 400mg administered on a 5 days on, 2 days off intermittent schedule
azenosertib
Azenosertib (ZN-c3) will be administered orally.
Part 2a: Arm 2
Azenosertib 300mg administered on a 5 days on, 2 days off intermittent schedule
azenosertib
Azenosertib (ZN-c3) will be administered orally.
Part 1a/1b (Completed Enrollment)
Azenosertib 400mg administered on a 5 days on, 2 days off intermittent schedule.
azenosertib
Azenosertib (ZN-c3) will be administered orally.
Interventions
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azenosertib
Azenosertib (ZN-c3) will be administered orally.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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. One to 3 prior lines or regimens are allowed (1 to 4 prior lines are permitted, if prior mirvetuximab)
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
2. 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.
3. Prior therapy with ZN-c3 or any other WEE1 inhibitor, ATR inhibitor, PKMYT1 inhibitor, or CHK1/2 inhibitor.
4. 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.
5. Unresolved toxicity of Grade \>1 attributed to any prior therapies (excluding Grade ≤2 neuropathy, alopecia, or skin pigmentation).
6. Pregnant or lactating female subject or female subject of childbearing potential who has a positive serum pregnancy test within 14 days prior to C1D1.
7. 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.
8. Subjects who are known to be immunocompromised or HIV-positive on highly active anti-retroviral therapy.
9. Subjects with known active hepatitis B or hepatitis C infection.
10. Individuals who are judged by the Investigator to be unsuitable as study subjects.
11. Subjects who had prior wide-field radiotherapy affecting ≥ 20% of the bone marrow.
18 Years
FEMALE
No
Sponsors
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K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc
INDUSTRY
Responsible Party
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Locations
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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 0239 - Florida Cancer Specialists - East
Daytona Beach, Florida, United States
Site 0173 - Mount Sinai Medical Center
Miami Beach, Florida, United States
Site 0308 - Advent Health
Orlando, 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 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 0234 - University of Texas Health, Memorial Hermann Hospital
Houston, Texas, United States
Site 0203 - Texas Oncology
Tyler, Texas, United States
Site 0295 - Virginia Oncology Associates
Chesapeake, Virginia, United States
Site 0323 - Compass Oncology
Vancouver, Washington, 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 3101 - AZORG - Aalst
Aalst, Oost-Vlaanderen, Belgium
Site 3105 - UZ Leuven
Leuven, Vlaams Brabant, Belgium
Site 3616 - Centre Antoine Lacassagne
Nice, Alpes-Maritimes, France
Site 3611 - ICANS - Institut de cancérologie Strasbourg Europe
Strasbourg, Bas-Rhin, 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
Napoli, 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 2414 - Med-Polonia Sp. z o.o.
Poznan, Greater Poland Voivodeship, Poland
Site 2405 - Centrum Badan Klinicznych JCI
Krakow, Lesser Poland Voivodeship, Poland
Site 2404 - Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie
Warsaw, Masovian 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 2909 - Severance Hospital Yonsei University Health System
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
Countries
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Central Contacts
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Facility Contacts
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Joanie Broemmelsiek
Role: primary
Role: primary
Cherise Lastra
Role: primary
Jennifer Hege
Role: primary
Martina Bedford
Role: primary
Nan Ash
Role: primary
[email protected]
Role: primary
Karen Schulz
Role: primary
Fatim Kragbe
Role: primary
Nancy Wan, MD
Role: primary
Alexa Ribatt, CRC
Role: backup
Hannah Sanchez-Garcia
Role: primary
Shannon Pierpoint
Role: primary
Scott Andrews
Role: primary
Akshitha Kasireddy
Role: primary
Katie Szeligo
Role: primary
Macy Kuhar
Role: primary
Role: backup
Jeanne Schaffer
Role: primary
Kristina Powell
Role: primary
Natasha Flier
Role: primary
Shelly Maxfield
Role: primary
Jenny Marks
Role: primary
Jesse Peet
Role: primary
Chris McKeon
Role: primary
Martin Oehler, MD
Role: primary
Joanne Tonkin
Role: primary
Tarek Meniawy
Role: primary
Philippe Follana
Role: primary
Jean-Sébastien Frénel
Role: primary
Benoit You
Role: primary
Claire Le Taillandier De Gabory
Role: primary
Iwona Zaba
Role: primary
Other Identifiers
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ZN-c3-005
Identifier Type: -
Identifier Source: org_study_id