Actively Recruiting
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
Eligibility Criteria
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
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
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
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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