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

June 29, 2026 updated by: K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc

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)

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.

Study Overview

Status

Recruiting

Conditions

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

Intervention / Treatment

Drug: azenosertib

Detailed Description

A Phase 2 study to evaluate the efficacy and safety of azenossertib (ZN-c3) in subjects with Platinum-Resistant, High-Grade Serous Ovarian, Fallopian Tube, or Primary Peritoneal Cancer. Azenosertib is a selective and orally bioavailable inhibitor of WEE1. By inhibiting WEE1, azenosertib enables cell cycle progression, despite high levels of DNA damage, thereby resulting in the accumulation of DNA damage leading to mitotic catastrophe and cancer cell death.

The study consists of two parts:

Part 1: All comers, no biomarker status required (completed enrollment)

Part 2: Cyclin E1 positive protein expression required

Study Type

Interventional

Enrollment (Estimated)

310

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Project Director
Phone Number: 858.263.4333
Email: medicalaffairs@zentalis.com

Study Locations

Australia
- Queensland
  - Chermside, Queensland, Australia, 4032
    - Recruiting
    - Site 2715 - Icon Cancer Centre - Chermside
    - Principal Investigator:
      
      Jeffrey Goh
    - Contact:
      
      Jesse Peet
      
      Phone Number: 61-7-3737-4539
  - South Brisbane, Queensland, Australia, 4101
    - Recruiting
    - Site 2707 - Mater Brisbane
    - Principal Investigator:
      
      Catherine Shannon
    - Contact:
      
      Chris McKeon
      
      Phone Number: 61-3-3163-7689
- South Australia
  - Adelaide, South Australia, Australia, 5037
    - Recruiting
    - Site 2709 - Cancer Research SA
    - Principal Investigator:
      
      Meena Okera
  - Toorak Gardens, South Australia, Australia, 5065
    - Recruiting
    - Site 2702 - Burnside War Memorial Hospital - The Brian Fricker Oncology Centre
    - Principal Investigator:
      
      Martin Oehler
    - Contact:
      
      Martin Oehler, MD
      
      Phone Number: 61-8-8202-7222
- Victoria
  - East Melbourne, Victoria, Australia, 3002
    - Recruiting
    - Site 2716 - Epworth Healthcare Freemasons
    - Principal Investigator:
      
      Sumitra Ananda
- Western Australia
  - Nedlands, Western Australia, Australia, 6009
    - Recruiting
    - Site 2701 - Sir Charles Gairdner Hospital
    - Contact:
      
      Joanne Tonkin
      
      Phone Number: 61 08 6383 3185
    - Principal Investigator:
      
      Tarek Meniawy
  - Subiaco, Western Australia, Australia, 6008
    - Recruiting
    - Site 2717 - St John of God Hospital Subiaco
    - Principal Investigator:
      
      Tarek Meniawy
    - Contact:
      
      Tarek Meniawy
      
      Phone Number: +61 8 6465 9204
Belgium
- Brussels Capital
  - Brussels, Brussels Capital, Belgium, 1200
    - Recruiting
    - Site 3102 - Cliniques Universitaires Saint-Luc
    - Principal Investigator:
      
      Jean-Francois Baurain
- Oost-Vlaanderen
  - Aalst, Oost-Vlaanderen, Belgium, 9300
    - Active, not recruiting
    - Site 3101 - AZORG - Aalst
- Vlaams Brabant
  - Leuven, Vlaams Brabant, Belgium, 3000
    - Recruiting
    - Site 3105 - UZ Leuven
    - Principal Investigator:
      
      Toon van Gorp
France
- - Lyon, France, 69373
    - Recruiting
    - Site 3619 - Centre Léon Bérard
    - Principal Investigator:
      
      Olivia Le Saux
  - Strasbourg, France, 67200
    - Recruiting
    - Site 3620 - CHU de Strasbourg - Hopital de Hautepierre
    - Principal Investigator:
      
      Lauriane EBERST
  - Villejuif, France, 94800
    - Recruiting
    - Site 3604 - Institut Gustave Roussy
    - Principal Investigator:
      
      Alexandra LEARY
    - Contact:
      
      Claire Le Taillandier De Gabory
- Alpes-Maritimes
  - Nice, Alpes-Maritimes, France, 06100
    - Recruiting
    - Site 3616 - Centre Antoine Lacassagne
    - Principal Investigator:
      
      Philippe Follana
    - Contact:
      
      Philippe FOLLANA
- Bas-Rhin
  - Strasbourg, Bas-Rhin, France, 67200
    - Active, not recruiting
    - Site 3611 - ICANS - Institut de cancérologie Strasbourg Europe
- Côte-d'Or
  - Dijon, Côte-d'Or, France, 21079
    - Recruiting
    - Site 3601 - Centre Georges François Leclerc
    - Principal Investigator:
      
      Jean-David Fumet
- Doubs
  - Besançon, Doubs, France, 25030
    - Recruiting
    - Site 3613 - CHRU Besancon - Hopital Jean Minjoz
    - Principal Investigator:
      
      Laura Mansi
- Finistere
  - Brest, Finistere, France, 29200
    - Recruiting
    - Site 3617 - CHU de Brest - Hôpital La Cavale Blanche
    - Principal Investigator:
      
      Laura Deiana
- Haute-Garonne
  - Toulouse, Haute-Garonne, France, 31000
    - Recruiting
    - Site 3603 - Institut Claudius Regaud
    - Principal Investigator:
      
      Laurence Gladieff
- Nord
  - Lille, Nord, France, 59000
    - Recruiting
    - Site 3602 - Centre Oscar Lambret
    - Principal Investigator:
      
      Cyril Abdeddaim
- Paris
  - Paris, Paris, France, 75181
    - Recruiting
    - Site 3615 - Hôpital Cochin Port-Royal AP-HP
    - Principal Investigator:
      
      Jerome Alexandre
- Pays de la Loire Region
  - Saint-Herblain, Pays de la Loire Region, France, 44800
    - Recruiting
    - Site 3614 - Institut de Cancerologie de l'oust
    - Principal Investigator:
      
      Jean-Sébastien FRENEL
    - Contact:
      
      Jean-Sébastien Frénel
- Rhône
  - Pierre-Bénite, Rhône, France, 69310
    - Recruiting
    - Site 3608 - Hospices Civils de Lyon - Hôpital Lyon Sud
    - Principal Investigator:
      
      BENOIT YOU
    - Contact:
      
      Benoit YOU
Italy
- - Bologna, Italy, 40138
    - Recruiting
    - Site 3303 - Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi-Via Massarenti
    - Principal Investigator:
      
      Claudio Zamagni
- Campania
  - Naples, Campania, Italy, 80131
    - Recruiting
    - Site 3302 - Istituto Nazionale Tumori IRCCS Fondazione Giovanni Pascale
    - Principal Investigator:
      
      Sabrina Cecere
- Emilia-Romagna
  - Modena, Emilia-Romagna, Italy, 41124
    - Recruiting
    - Site 3308 - Azienda Ospedaliero Universitaria Di Modena Policlinico
    - Principal Investigator:
      
      Roberto Sabbatini
- Friuli Venezia Giulia
  - Aviano, Friuli Venezia Giulia, Italy, 33081
    - Recruiting
    - Site 3312 - Centro di Riferimento Oncologico
    - Principal Investigator:
      
      Michele Bartoletti
- Lazio
  - Rome, Lazio, Italy, 168
    - Recruiting
    - Site 3304 - Fondazione Policlinico Universitario A Gemelli
    - Principal Investigator:
      
      Anna Fagotti
- Lombardy
  - Milan, Lombardy, Italy, 20141
    - Recruiting
    - Site 3305 - Istituto Europeo di Oncologia
    - Principal Investigator:
      
      Nicoletta Colombo
- Milano
  - Milan, Milano, Italy, 20132
    - Recruiting
    - Site 3307 - Ospedale San Raffaele S.r.l.
    - Principal Investigator:
      
      Alice Bergamini
- Veneto
  - Verona, Veneto, Italy, 37126
    - Recruiting
    - Site 3311 - Azienda Ospedaliera Universitaria Integrata Di Verona
    - Principal Investigator:
      
      Andrea Zivi
Poland
- Greater Poland Voivodeship
  - Poznan, Greater Poland Voivodeship, Poland, 60-693
    - Active, not recruiting
    - Site 2414 - Med-Polonia Sp. z o.o.
- Lesser Poland Voivodeship
  - Krakow, Lesser Poland Voivodeship, Poland, 30-348
    - Recruiting
    - Site 2405 - Centrum Badan Klinicznych JCI
    - Principal Investigator:
      
      Pawel Blecharz
    - Contact:
      
      Iwona Zaba
- Masovian Voivodeship
  - Warsaw, Masovian Voivodeship, Poland, 02-781
    - Recruiting
    - Site 2404 - Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie
    - Principal Investigator:
      
      Iwona Lugowska
- Podlaskie Voivodeship
  - Bialystok, Podlaskie Voivodeship, Poland, 15-027
    - Recruiting
    - Site 2419 - Bialostockie Centrum Onkologii im. Marii Sklodowskiej-Curie w Bialymstoku
    - Principal Investigator:
      
      Beata Maćkowiak-Matejczyk
- Pomeranian Voivodeship
  - Gdynia, Pomeranian Voivodeship, Poland, 81-519
    - Recruiting
    - Site 2421 - Szpitale Pomorskie Sp. z o. o.
    - Principal Investigator:
      
      Joanna Pikiel
South Korea
- - Seoul, South Korea, 03722
    - Recruiting
    - Site 2909 - Severance Hospital Yonsei University Health System
    - Principal Investigator:
      
      Jung-Yun Lee
  - Seoul, South Korea, 06273
    - Recruiting
    - Site 2906 - Gangnam Severance Hospital, Yonsei University Health System
    - Principal Investigator:
      
      Jae-Hoon Kim
  - Seoul, South Korea, 06351
    - Recruiting
    - Site 2907 - Samsung Medical Center
    - Principal Investigator:
      
      Chel Hun Choi
  - Seoul, South Korea, 03080
    - Recruiting
    - Site 2905 - Seoul National University Hospital
    - Principal Investigator:
      
      Hee Seung Kim
  - Seoul, South Korea, 05505
    - Recruiting
    - Site 2904 - Asan Medical Center
    - Principal Investigator:
      
      Shin Wha Lee
- Gyeonggi-do
  - Goyang-si, Gyeonggi-do, South Korea, 10408
    - Recruiting
    - Site 2908 - National Cancer Center
Spain
- - Madrid, Spain, 28046
    - Recruiting
    - Site 3502 - Hospital Universitario La Paz
    - Principal Investigator:
      
      Sanchez Redondo
- Barcelona
  - Barcelona, Barcelona, Spain, 8035
    - Recruiting
    - Site 3511 - Instituto de Investigacion Oncologica Vall d'Hebron
    - Principal Investigator:
      
      Carmen Garcia Duran
- Madrid
  - Madrid, Madrid, Spain, 28027
    - Recruiting
    - Site 3517 - Clinica Universidad de Navarra
    - Principal Investigator:
      
      Antonio Gonzalez Martin
- Murcia
  - Murcia, Murcia, Spain, 30120
    - Recruiting
    - Site 3516 - Hospital Universitario Virgen de La Arrixaca
    - Principal Investigator:
      
      Jeronimo Martinez Garcia
- Valencia
  - Valencia, Valencia, Spain, 46010
    - Recruiting
    - Site 3501 - Hospital Clinico Universitario de Valencia
    - Principal Investigator:
      
      Jose Alejandro Perez Fidalgo
United States
- Alabama
  - Mobile, Alabama, United States, 36604
    - Recruiting
    - Site 0170-USA Mitchell Cancer Institute
    - Contact:
      
      Joanie Broemmelsiek
      
      Phone Number: 251-445-9866
    - Principal Investigator:
      
      Jennifer Pierce
- Arizona
  - Phoenix, Arizona, United States, 85016
    - Recruiting
    - Site 0143 - HonorHealth
    - Contact:
      
      Phone Number: 602-277-4868
    - Principal Investigator:
      
      Lindsay Willmott
  - Tucson, Arizona, United States, 85724
    - Recruiting
    - Site 0102 - University of Arizona Cancer Center
    - Principal Investigator:
      
      Setsuko Chambers
- California
  - La Jolla, California, United States, 92037
    - Active, not recruiting
    - Site 0258 - UC San Diego Moores Cancer Center
  - Santa Barbara, California, United States, 93105
    - Active, not recruiting
    - Site 0287 - Ridley Tree Cancer Center
- Colorado
  - Lone Tree, Colorado, United States, 80218
    - Recruiting
    - Site 0135 - Rocky Mountain Cancer Centers
    - Principal Investigator:
      
      Manojkumar Bupathi
    - Contact:
      
      Jennifer Hege
      
      Phone Number: 303-385-2067
- Connecticut
  - Hartford, Connecticut, United States, 06106
    - Recruiting
    - Site 0158 - Hartford HealthCare
    - Principal Investigator:
      
      Amy Brown
- Florida
  - Daytona Beach, Florida, United States, 32117
    - Recruiting
    - Site 0239 - Florida Cancer Specialists - East
    - Principal Investigator:
      
      Sumithra Vattigunta
    - Contact:
      
      Martina Bedford
      
      Phone Number: 820-545-2318
  - Lecanto, Florida, United States, 34461
    - Recruiting
    - Site 0241 - Florida Cancer Specialist - North
  - Miami Beach, Florida, United States, 33140
    - Recruiting
    - Site 0173 - Mount Sinai Medical Center
    - Principal Investigator:
      
      Brian Slomovitz
  - Orlando, Florida, United States, 32803
    - Recruiting
    - Site 0308 - Advent Health
    - Principal Investigator:
      
      Robert Holloway
- Georgia
  - Atlanta, Georgia, United States, 30322
    - Recruiting
    - Site 0108 - Emory University Hospital
    - Principal Investigator:
      
      Jennifer Scalici
  - Savannah, Georgia, United States, 31404
    - Active, not recruiting
    - Site 0236 - Memorial Health
- Illinois
  - Niles, Illinois, United States, 60714
    - Active, not recruiting
    - Site 0324 - Illinois Cancer Specialists
- Indiana
  - Indianapolis, Indiana, United States, 46260
    - Recruiting
    - Site 0217 - St Vincent Hospital and Health Care Centers
    - Principal Investigator:
      
      Michael Callahan
  - Indianapolis, Indiana, United States, 46250
    - Recruiting
    - Site 0284 - Community Cancer Center North
    - Principal Investigator:
      
      Natraj Reddy Ammakkanavar
    - Contact:
      
      Nan Ash
      
      Phone Number: 317-621-4290
- Kentucky
  - Louisville, Kentucky, United States, 40202
    - Recruiting
    - Site 0251 - Norton Cancer Institute
    - Contact:
      
      GYN-NCIResearch@nortonhealthcare.org
      
      Phone Number: 502-899-3366
    - Principal Investigator:
      
      Justin Gorski
- Maryland
  - Rockville, Maryland, United States, 20876
    - Active, not recruiting
    - Site 0146 - Maryland Oncology Hematology, PA
- Massachusetts
  - Boston, Massachusetts, United States, 02111
    - Recruiting
    - Site 0221 - Tufts Medical Center - PPDS
    - Principal Investigator:
      
      Sarah Paraghamian
    - Contact:
      
      Fatim Kragbe
      
      Phone Number: 617-636-2616
  - Boston, Massachusetts, United States, 02215
    - Recruiting
    - Site 0104 - Dana Farber Cancer Institute
    - Principal Investigator:
      
      Joyce Liu
  - Burlington, Massachusetts, United States, 01805
    - Recruiting
    - Site 0307 - Lahey Hospital and Medical Center
    - Contact:
      
      Alexa Ribatt, CRC
      
      Phone Number: 781-744-3421
    - Principal Investigator:
      
      Corrine Zarwan
    - Contact:
      
      Nancy Wan, MD
      
      Phone Number: 781-744-3055
  - Springfield, Massachusetts, United States, 01199
    - Recruiting
    - Site 0263 - Baystate Medical Center
    - Principal Investigator:
      
      Tashanna Myers
- Michigan
  - Detroit, Michigan, United States, 48201
    - Recruiting
    - Site 0101 - Barbara Ann Karmanos Cancer Institute
    - Principal Investigator:
      
      Robert Morris
  - Grand Rapids, Michigan, United States, 49503
    - Recruiting
    - Site 0228 - Corewell Health Medical Group West
    - Principal Investigator:
      
      Gregory Gressel
- Minnesota
  - Maplewood, Minnesota, United States, 55109
    - Recruiting
    - Site 0288 - Minnesota Oncology Hematology - Maplewood
    - Principal Investigator:
      
      Jessica Thomes Pepin
    - Contact:
      
      Hannah Sanchez-Garcia
      
      Phone Number: 612-884-6321
- Missouri
  - Springfield, Missouri, United States, 65807
    - Active, not recruiting
    - Site 0226 - CoxHealth
- Nebraska
  - Omaha, Nebraska, United States, 68114
    - Active, not recruiting
    - Site 0317 - Nebraska Methodist Hospital
- Nevada
  - Reno, Nevada, United States, 89511
    - Recruiting
    - Site 0213 - Center of Hope
    - Contact:
      
      Shannon Pierpoint
      
      Phone Number: 775-327-4673
    - Principal Investigator:
      
      Peter Lim
- New York
  - Manhasset, New York, United States, 11030
    - Active, not recruiting
    - Site 0231 - Northwell Health Cancer Institute
  - Rochester, New York, United States, 14642
    - Recruiting
    - Site 0126 - Wilmot Cancer Center
    - Principal Investigator:
      
      Rachael Turner
- North Carolina
  - Durham, North Carolina, United States, 27710
    - Recruiting
    - Site 0259 - Duke Cancer Center
    - Principal Investigator:
      
      Angeles Secord
    - Contact:
      
      Scott Andrews
      
      Phone Number: 919-684-3780
- Ohio
  - Cincinnati, Ohio, United States, 45242
    - Recruiting
    - Site 0147 - Trihealth Cancer Institute - Harold and Eugen
    - Contact:
      
      Akshitha Kasireddy
      
      Phone Number: 513-862-1650
    - Principal Investigator:
      
      Rachel Bramblet
  - Columbus, Ohio, United States, 43219
    - Recruiting
    - Site 0243 - Mark H Zangmeister Cancer Center
    - Principal Investigator:
      
      Emily Whitman-Purves
    - Contact:
      
      Katie Szeligo
      
      Phone Number: 614-383-6194
  - Hilliard, Ohio, United States, 43026
    - Recruiting
    - Site 0214-Ohio State University Comprehensive Cancer Center
    - Contact:
      
      Macy Kuhar
    - Principal Investigator:
      
      Floor Backes
    - Contact:
      
      Phone Number: 614-257-3753
- Oregon
  - Eugene, Oregon, United States, 97401
    - Recruiting
    - Site 0316 - Willamette Valley Cancer Institute/Oncology Associates of Oregon
    - Principal Investigator:
      
      Charles Anderson
    - Contact:
      
      Jeanne Schaffer
      
      Phone Number: 541-638-5012
- Pennsylvania
  - Philadelphia, Pennsylvania, United States, 19104
    - Recruiting
    - Site 0232 - University of Pennsylvania
    - Principal Investigator:
      
      Fiona Simpkins
    - Contact:
      
      Kristina Powell
      
      Phone Number: 215-220-9535
  - Philadelphia, Pennsylvania, United States, 19107
    - Recruiting
    - Site 0178 - Thomas Jefferson University
    - Principal Investigator:
      
      Ida Micaily
  - Wynnewood, Pennsylvania, United States, 19096
    - Active, not recruiting
    - Site 0277 - Alliance Cancer Specialist, PC
- South Dakota
  - Sioux Falls, South Dakota, United States, 57105
    - Recruiting
    - Site 0132 - Avera Cancer Institute
    - Principal Investigator:
      
      David Starks
    - Contact:
      
      Natasha Flier
- Texas
  - Houston, Texas, United States, 77030
    - Recruiting
    - Site 0103 - University of Texas MD Anderson Cancer Center
    - Principal Investigator:
      
      Shannon Westin
  - Houston, Texas, United States, 77030
    - Active, not recruiting
    - Site 0234 - University of Texas Health, Memorial Hermann Hospital
  - Tyler, Texas, United States, 75702
    - Recruiting
    - Site 0203 - Texas Oncology
    - Principal Investigator:
      
      Anna M Priebe
    - Contact:
      
      Shelly Maxfield
      
      Phone Number: 903-579-9840
- Virginia
  - Chesapeake, Virginia, United States, 23320
    - Recruiting
    - Site 0295 - Virginia Oncology Associates
    - Principal Investigator:
      
      Devin Miller
    - Contact:
      
      Jenny Marks
      
      Phone Number: 757-873-9832
  - Fairfax, Virginia, United States, 22031
    - Recruiting
    - Site 0322 - Inova Schar Cancer Institute
    - Principal Investigator:
      
      Leslie Randall
- Washington
  - Vancouver, Washington, United States, 98684
    - Active, not recruiting
    - Site 0323 - Compass Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Description

Inclusion Criteria:

Age ≥18 years
High-grade serous ovarian, fallopian tube or primary peritoneal cancer
Tumor testing (archival acceptable) confirms a positive Cyclin E1 protein status result determined by IHC using the Sponsor's investigational clinical trial assay
Prior therapy:
1. Subjects must have platinum-resistant disease
2. Parts 2a and 2b: One to 3 prior lines or regimens are allowed (1 to 4 prior lines are permitted, if prior mirvetuximab)
3. Part 2c: Subjects with PROC may have 1 to 4 prior lines or regimens. Prior treatment in this cohort includes a weekly taxane regimen, either as single agent or in combination, per protocol
4. Prior bevacizumab treatment is required, if eligible per standard of care
5. Prior PARP inhibitor treatment is required if BRCA 1/2 mutation or HRD, if eligible per standard of care
6. Prior mirvetuximab treatment is required, if eligible per standard of care
Measurable disease per RECIST Version 1.1.
Adequate hematologic and organ function, as defined in protocol
ECOG 0-1

Exclusion Criteria:

Primary platinum-refractory disease
Subjects with endometrioid, clear cell, mucinous, or sarcomatous histology, mixed tumors containing any of the above histologies, low-grade, borderline, or other ovarian tumors
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.
Prior therapy with ZN-c3 or any other WEE1 inhibitor, ATR inhibitor, PKMYT1 inhibitor, or CHK1/2 inhibitor.
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.
Unresolved toxicity of Grade >1 attributed to any prior therapies (excluding Grade ≤2 neuropathy, alopecia, or skin pigmentation).
Pregnant or lactating female subject or female subject of childbearing potential who has a positive serum pregnancy test within 14 days prior to C1D1.
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.
Subjects who are known to be immunocompromised or HIV-positive on highly active anti-retroviral therapy.
Subjects with known active hepatitis B or hepatitis C infection.
Individuals who are judged by the Investigator to be unsuitable as study subjects.
Subjects who had prior wide-field radiotherapy affecting ≥ 20% of the bone marrow.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1a/1b (Completed Enrollment) Azenosertib 400mg administered once daily on a 5 days on, 2 days off intermittent schedule.	Drug: azenosertib Azenosertib (ZN-c3) will be administered orally. Other Names: ZN-c3
Experimental: Part 2a: Arm 1 (Completed Enrollment) Azenosertib 400mg administered once daily on a 5 days on, 2 days off intermittent schedule	Drug: azenosertib Azenosertib (ZN-c3) will be administered orally. Other Names: ZN-c3
Experimental: Part 2a: Arm 2 (Completed Enrollment) Azenosertib 300mg administered once daily on a 5 days on, 2 days off intermittent schedule	Drug: azenosertib Azenosertib (ZN-c3) will be administered orally. Other Names: ZN-c3
Experimental: Part 2b Azenosertib 400mg administered once daily on a 5 days on, 2 days off intermittent schedule	Drug: azenosertib Azenosertib (ZN-c3) will be administered orally. Other Names: ZN-c3
Experimental: Part 2c Azenosertib 400mg administered once daily on a 5 days on, 2 days off intermittent schedule	Drug: azenosertib Azenosertib (ZN-c3) will be administered orally. Other Names: ZN-c3

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate (ORR) defined by RECIST v1.1 [Part 2] Time Frame: Up to approximately 12 months from the enrollment of the last subject	Participants who achieve partial response (PR) or complete response (CR) per RECIST v1.1 criteria.	Up to approximately 12 months from the enrollment of the last subject

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of response (DOR) defined by RECIST v1.1 [Part 2] Time Frame: Up to approximately 12 months from the enrollment of the last subject	Time from the date of first documented response (CR or PR that is subsequently confirmed per RECIST v1.1) until the date of progressive disease (PD) or death.	Up to approximately 12 months from the enrollment of the last subject
Progression free survival (PFS) defined by RECIST v1.1 [Part 2] Time Frame: Up to approximately 12 months from the enrollment of the last subject	Time from the date of first dose until the date of PD or death.	Up to approximately 12 months from the enrollment of the last subject
Clinical Benefit Rate (CBR) defined by RECIST v1.1 [Part 2] Time Frame: Up to approximately 12 months from the enrollment of the last subject	The percentage of participants who have at least 1 confirmed response of CR or PR, or stable disease for at least 16 weeks before any evidence of progression.	Up to approximately 12 months from the enrollment of the last subject
CA-125 response by GCIG criteria [Part 2] Time Frame: Up to approximately 12 months from the enrollment of the last subject	The GCIG CA-125 response was defined as at least 50% reduction in CA-125 levels from baseline.	Up to approximately 12 months from the enrollment of the last subject
Number of Subjects experiencing treatment emergent adverse events (TEAEs) [Part 2] Time Frame: Up to approximately 12 months from the enrollment of the last subject		Up to approximately 12 months from the enrollment of the last subject

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 17, 2022

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

October 28, 2021

First Submitted That Met QC Criteria

November 9, 2021

First Posted (Actual)

November 22, 2021

Study Record Updates

Last Update Posted (Actual)

July 1, 2026

Last Update Submitted That Met QC Criteria

June 29, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Cyclin E1, CCNE1, Ovarian Cancer, Platinum Resistant, WEE1 inhibitor, DENALI, GOG-3066

Additional Relevant MeSH Terms

Other Study ID Numbers

ZN-c3-005

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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

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)

Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Estimated)

Phase

Contacts and Locations

Study Contact

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.