Actively Recruiting

Phase 2
Age: 18Years +
FEMALE
NCT05128825

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

Led by K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc · Updated on 2026-05-01

310

Participants Needed

91

Research Sites

279 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Diagnosis of high-grade serous ovarian, fallopian tube, or primary peritoneal cancer
  • Tumor tests positive for Cyclin E1 protein status by immunohistochemistry
  • Platinum-resistant disease
  • One to three prior lines of therapy allowed (up to four if prior mirvetuximab treatment)
  • Prior bevacizumab treatment required if eligible
  • Prior PARP inhibitor treatment required if BRCA 1/2 mutation or homologous recombination deficiency, if eligible
  • Prior mirvetuximab treatment required if eligible
  • Measurable disease according to RECIST version 1.1
  • Adequate blood counts and organ function as defined in protocol
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Not Eligible

You will not qualify if you...

  • Primary platinum-refractory disease
  • Endometrioid, clear cell, mucinous, or sarcomatous histology, or mixed tumors containing these types
  • Low-grade, borderline, or other ovarian tumor types
  • Major surgery within 28 days before starting treatment
  • Hospitalization within 14 days before starting treatment
  • Chemotherapy or targeted therapy within 21 days or 5 half-lives, whichever is shorter
  • Radiation therapy within 21 days before treatment
  • Stem cell transplant within 3 months before treatment
  • Use of other investigational drugs within 28 days or 5 half-lives, whichever is shorter
  • Inability to stop certain drugs or supplements that affect drug metabolism at least 14 days before treatment
  • Prior therapy with ZN-c3 or other WEE1, ATR, PKMYT1, or CHK1/2 inhibitors
  • Serious medical conditions including unstable brain metastases, heart failure (NYHA Class II-IV), severe medical or psychiatric conditions, recent acute kidney injury, significant gastrointestinal problems affecting oral medication intake, active uncontrolled infection, bowel obstruction, or recent procedures related to these conditions
  • Unresolved toxicity greater than Grade 1 from prior therapies (except Grade 2 or less neuropathy, hair loss, or skin changes)
  • Pregnant or breastfeeding women or positive pregnancy test within 14 days prior to treatment
  • History of another cancer within 2 years unless cured by surgery alone and continuously disease-free
  • Known immunocompromised status or HIV-positive on highly active antiretroviral therapy
  • Active hepatitis B or C infection
  • Prior wide-field radiotherapy affecting 20% or more of bone marrow
  • Deemed unsuitable for study participation by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 91 locations

1

Site 0170-USA Mitchell Cancer Institute

Mobile, Alabama, United States, 36604

Actively Recruiting

2

Site 0143 - HonorHealth

Phoenix, Arizona, United States, 85016

Actively Recruiting

3

Site 0102 - University of Arizona Cancer Center

Tucson, Arizona, United States, 85724

Actively Recruiting

4

Site 0258 - UC San Diego Moores Cancer Center

La Jolla, California, United States, 92037

Active, Not Recruiting

5

Site 0287 - Ridley Tree Cancer Center

Santa Barbara, California, United States, 93105

Active, Not Recruiting

6

Site 0135 - Rocky Mountain Cancer Centers

Lone Tree, Colorado, United States, 80218

Active, Not Recruiting

7

Site 0158 - Hartford HealthCare

Hartford, Connecticut, United States, 06106

Actively Recruiting

8

Site 0239 - Florida Cancer Specialists - East

Daytona Beach, Florida, United States, 32117

Actively Recruiting

9

Site 0173 - Mount Sinai Medical Center

Miami Beach, Florida, United States, 33140

Actively Recruiting

10

Site 0308 - Advent Health

Orlando, Florida, United States, 32803

Actively Recruiting

11

Site 0108 - Emory University Hospital

Atlanta, Georgia, United States, 30322

Actively Recruiting

12

Site 0236 - Memorial Health

Savannah, Georgia, United States, 31404

Active, Not Recruiting

13

Site 0324 - Illinois Cancer Specialists

Niles, Illinois, United States, 60714

Active, Not Recruiting

14

Site 0284 - Community Cancer Center North

Indianapolis, Indiana, United States, 46250

Actively Recruiting

15

Site 0217 - St Vincent Hospital and Health Care Centers

Indianapolis, Indiana, United States, 46260

Actively Recruiting

16

Site 0251 - Norton Cancer Institute

Louisville, Kentucky, United States, 40202

Actively Recruiting

17

Site 0146 - Maryland Oncology Hematology, PA

Rockville, Maryland, United States, 20876

Active, Not Recruiting

18

Site 0221 - Tufts Medical Center - PPDS

Boston, Massachusetts, United States, 02111

Actively Recruiting

19

Site 0104 - Dana Farber Cancer Institute

Boston, Massachusetts, United States, 02215

Actively Recruiting

20

Site 0307 - Lahey Hospital and Medical Center

Burlington, Massachusetts, United States, 01805

Actively Recruiting

21

Site 0263 - Baystate Medical Center

Springfield, Massachusetts, United States, 01199

Actively Recruiting

22

Site 0101 - Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, United States, 48201

Actively Recruiting

23

Site 0228 - Corewell Health Medical Group West

Grand Rapids, Michigan, United States, 49503

Actively Recruiting

24

Site 0288 - Minnesota Oncology Hematology - Maplewood

Maplewood, Minnesota, United States, 55109

Actively Recruiting

25

Site 0226 - CoxHealth

Springfield, Missouri, United States, 65807

Active, Not Recruiting

26

Site 0317 - Nebraska Methodist Hospital

Omaha, Nebraska, United States, 68114

Active, Not Recruiting

27

Site 0213 - Center of Hope

Reno, Nevada, United States, 89511

Actively Recruiting

28

Site 0231 - Northwell Health Cancer Institute

Manhasset, New York, United States, 11030

Active, Not Recruiting

29

Site 0126 - Wilmot Cancer Center

Rochester, New York, United States, 14642

Actively Recruiting

30

Site 0259 - Duke Cancer Center

Durham, North Carolina, United States, 27710

Actively Recruiting

31

Site 0147 - Trihealth Cancer Institute - Harold and Eugen

Cincinnati, Ohio, United States, 45242

Actively Recruiting

32

Site 0243 - Mark H Zangmeister Cancer Center

Columbus, Ohio, United States, 43219

Actively Recruiting

33

Site 0214-Ohio State University Comprehensive Cancer Center

Hilliard, Ohio, United States, 43026

Actively Recruiting

34

Site 0316 - Willamette Valley Cancer Institute/Oncology Associates of Oregon

Eugene, Oregon, United States, 97401

Actively Recruiting

35

Site 0232 - University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

36

Site 0178 - Thomas Jefferson University

Philadelphia, Pennsylvania, United States, 19107

Actively Recruiting

37

Site 0277 - Alliance Cancer Specialist, PC

Wynnewood, Pennsylvania, United States, 19096

Active, Not Recruiting

38

Site 0132 - Avera Cancer Institute

Sioux Falls, South Dakota, United States, 57105

Actively Recruiting

39

Site 0103 - University of Texas MD Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

40

Site 0234 - University of Texas Health, Memorial Hermann Hospital

Houston, Texas, United States, 77030

Actively Recruiting

41

Site 0203 - Texas Oncology

Tyler, Texas, United States, 75702

Actively Recruiting

42

Site 0295 - Virginia Oncology Associates

Chesapeake, Virginia, United States, 23320

Actively Recruiting

43

Site 0322 - Inova Schar Cancer Institute

Fairfax, Virginia, United States, 22031

Actively Recruiting

44

Site 0323 - Compass Oncology

Vancouver, Washington, United States, 98684

Active, Not Recruiting

45

Site 2715 - Icon Cancer Centre - Chermside

Chermside, Queensland, Australia, 4032

Actively Recruiting

46

Site 2707 - Mater Brisbane

South Brisbane, Queensland, Australia, 4101

Actively Recruiting

47

Site 2709 - Cancer Research SA

Adelaide, South Australia, Australia, 5037

Actively Recruiting

48

Site 2702 - Burnside War Memorial Hospital - The Brian Fricker Oncology Centre

Toorak Gardens, South Australia, Australia, 5065

Actively Recruiting

49

Site 2716 - Epworth Healthcare Freemasons

East Melbourne, Victoria, Australia, 3002

Actively Recruiting

50

Site 2701 - Sir Charles Gairdner Hospital

Nedlands, Western Australia, Australia, 6009

Actively Recruiting

51

Site 2717 - St John of God Hospital Subiaco

Subiaco, Western Australia, Australia, 6008

Actively Recruiting

52

Site 3102 - Cliniques Universitaires Saint-Luc

Brussels, Brussels Capital, Belgium, 1200

Actively Recruiting

53

Site 3101 - AZORG - Aalst

Aalst, Oost-Vlaanderen, Belgium, 9300

Active, Not Recruiting

54

Site 3105 - UZ Leuven

Leuven, Vlaams Brabant, Belgium, 3000

Actively Recruiting

55

Site 3616 - Centre Antoine Lacassagne

Nice, Alpes-Maritimes, France, 06100

Actively Recruiting

56

Site 3611 - ICANS - Institut de cancérologie Strasbourg Europe

Strasbourg, Bas-Rhin, France, 67200

Actively Recruiting

57

Site 3601 - Centre Georges François Leclerc

Dijon, Côte-d'Or, France, 21079

Actively Recruiting

58

Site 3613 - CHRU Besancon - Hopital Jean Minjoz

Besançon, Doubs, France, 25030

Actively Recruiting

59

Site 3617 - CHU de Brest - Hôpital La Cavale Blanche

Brest, Finistere, France, 29200

Actively Recruiting

60

Site 3603 - Institut Claudius Regaud

Toulouse, Haute-Garonne, France, 31000

Actively Recruiting

61

Site 3602 - Centre Oscar Lambret

Lille, Nord, France, 59000

Actively Recruiting

62

Site 3615 - Hôpital Cochin Port-Royal AP-HP

Paris, Paris, France, 75181

Actively Recruiting

63

Site 3614 - Institut de Cancerologie de l'oust

Saint-Herblain, Pays de la Loire Region, France, 44800

Actively Recruiting

64

Site 3608 - Hospices Civils de Lyon - Hôpital Lyon Sud

Pierre-Bénite, Rhône, France, 69310

Actively Recruiting

65

Site 3619 - Centre Léon Bérard

Lyon, France, 69373

Actively Recruiting

66

Site 3620 - CHU de Strasbourg - Hopital de Hautepierre

Strasbourg, France, 67200

Actively Recruiting

67

Site 3604 - Institut Gustave Roussy

Villejuif, France, 94800

Actively Recruiting

68

Site 3302 - Istituto Nazionale Tumori IRCCS Fondazione Giovanni Pascale

Naples, Campania, Italy, 80131

Actively Recruiting

69

Site 3308 - Azienda Ospedaliero Universitaria Di Modena Policlinico

Modena, Emilia-Romagna, Italy, 41124

Actively Recruiting

70

Site 3312 - Centro di Riferimento Oncologico

Aviano, Friuli Venezia Giulia, Italy, 33081

Actively Recruiting

71

Site 3304 - Fondazione Policlinico Universitario A Gemelli

Rome, Lazio, Italy, 168

Actively Recruiting

72

Site 3305 - Istituto Europeo di Oncologia

Milan, Lombardy, Italy, 20141

Actively Recruiting

73

Site 3307 - Ospedale San Raffaele S.r.l.

Milan, Milano, Italy, 20132

Actively Recruiting

74

Site 3311 - Azienda Ospedaliera Universitaria Integrata Di Verona

Verona, Veneto, Italy, 37126

Actively Recruiting

75

Site 3303 - Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi-Via Massarenti

Bologna, Italy, 40138

Actively Recruiting

76

Site 2414 - Med-Polonia Sp. z o.o.

Poznan, Greater Poland Voivodeship, Poland, 60-693

Active, Not Recruiting

77

Site 2405 - Centrum Badan Klinicznych JCI

Krakow, Lesser Poland Voivodeship, Poland, 30-348

Actively Recruiting

78

Site 2404 - Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie

Warsaw, Masovian Voivodeship, Poland, 02-781

Actively Recruiting

79

Site 2419 - Bialostockie Centrum Onkologii im. Marii Sklodowskiej-Curie w Bialymstoku

Bialystok, Podlaskie Voivodeship, Poland, 15-027

Actively Recruiting

80

Site 2421 - Szpitale Pomorskie Sp. z o. o.

Gdynia, Pomeranian Voivodeship, Poland, 81-519

Actively Recruiting

81

Site 2908 - National Cancer Center

Goyang-si, Gyeonggi-do, South Korea, 10408

Actively Recruiting

82

Site 2905 - Seoul National University Hospital

Seoul, South Korea, 03080

Actively Recruiting

83

Site 2909 - Severance Hospital Yonsei University Health System

Seoul, South Korea, 03722

Actively Recruiting

84

Site 2904 - Asan Medical Center

Seoul, South Korea, 05505

Actively Recruiting

85

Site 2906 - Gangnam Severance Hospital, Yonsei University Health System

Seoul, South Korea, 06273

Actively Recruiting

86

Site 2907 - Samsung Medical Center

Seoul, South Korea, 06351

Actively Recruiting

87

Site 3511 - Instituto de Investigacion Oncologica Vall d'Hebron

Barcelona, Barcelona, Spain, 8035

Actively Recruiting

88

Site 3517 - Clinica Universidad de Navarra

Madrid, Madrid, Spain, 28027

Actively Recruiting

89

Site 3516 - Hospital Universitario Virgen de La Arrixaca

Murcia, Murcia, Spain, 30120

Actively Recruiting

90

Site 3501 - Hospital Clinico Universitario de Valencia

Valencia, Valencia, Spain, 46010

Actively Recruiting

91

Site 3502 - Hospital Universitario La Paz

Madrid, Spain, 28046

Actively Recruiting

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Research Team

P

Project Director

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

5

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