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RECRUITING

NCT05128825

PHASE2

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

View on ClinicalTrials.gov

Summary

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.

Official title: A Phase 2 Open-Label, Multicenter Study To Evaluate Efficacy And Safety Of ZN-c3 In Subjects With High-Grade Serous Ovarian, Fallopian Tube, Or Primary Peritoneal Cancer (DENALI / ZN-c3-005 / GOG-3066)

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

170

Start Date

2022-02-17

Completion Date

2027-06-30

Last Updated

2026-04-09

Healthy Volunteers

Conditions

High-Grade Serous Ovarian, Fallopian Tube or Primary Peritoneal Cancer

Interventions

DRUG

azenosertib

Azenosertib (ZN-c3) will be administered orally.

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. 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: 1. Primary platinum-refractory disease 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.

Locations (90)

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 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 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 0322 - Inova Schar Cancer Institute

Fairfax, 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

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 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 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

Clinical Research Directory

A Study of Azenosertib (ZN-c3) in Subjects With Platinum-Resistant High-Grade Serous Ovarian, Fallopian Tube or Primary Peritoneal Cancer

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (90)