RecruitingPhase 2NCT05128825

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

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)

Sponsor

K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc

Enrollment

310 participants

Start Date

Feb 17, 2022

Study Type

INTERVENTIONAL

Conditions

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

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a drug called azenosertib (ZN-c3) — a WEE1 inhibitor that disrupts a key cell cycle checkpoint — in people with platinum-resistant high-grade serous ovarian, fallopian tube, or primary peritoneal cancer that also has high levels of Cyclin E1 protein. Platinum-resistant means the cancer stopped responding to standard platinum-based chemotherapy. Cyclin E1 overexpression is a biomarker that may predict who responds best to this drug. **You may be eligible if...** - You are 18 or older with high-grade serous ovarian, fallopian tube, or primary peritoneal cancer - A tumor test shows positive Cyclin E1 protein (by the sponsor's IHC assay) - Your cancer has become platinum-resistant (progressed within 6 months of last platinum chemotherapy) - You have had 1–3 prior treatment lines (or up to 4 if one was mirvetuximab) - You have previously received bevacizumab and PARP inhibitors (if eligible per standard care) - Your cancer can be measured on scans and your ECOG performance is 0–1 **You may NOT be eligible if...** - Your disease is considered primary platinum-refractory (never responded to platinum) - You have had major surgery, chemotherapy, or radiation within the past 3–4 weeks - You have active brain metastases, uncontrolled heart problems, or serious liver disease - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGazenosertib

Azenosertib (ZN-c3) will be administered orally.

Locations(91)

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 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

View Full Details on ClinicalTrials.gov

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NCT05128825