NCT05128825From ClinicalTrials.govRecruiting

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)

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

At a glance

Phase: Phase 2
Study type: Interventional
Sponsor: K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc
Enrolment target: 310
Started: 17 February 2022
Main results due: 1 December 2026
Study sites: 86
Registry updated: 29 September 2026

Can you take part?

Aged 18 years and over.
Women only.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria

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. 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
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. Subjects with endometrioid, clear cell, mucinous, or sarcomatous histology, mixed tumors containing any of the above histologies, low-grade, borderline, or other ovarian tumors
3. 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.
4. Prior therapy with ZN-c3 or any other WEE1 inhibitor, ATR inhibitor, PKMYT1 inhibitor, or CHK1/2 inhibitor.
5. 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.
6. Unresolved toxicity of Grade \>1 attributed to any prior therapies (excluding Grade ≤2 neuropathy, alopecia, or skin pigmentation).
7. Pregnant or lactating female subject or female subject of childbearing potential who has a positive serum pregnancy test within 14 days prior to C1D1.
8. 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.
9. Subjects who are known to be immunocompromised or HIV-positive on highly active anti-retroviral therapy.
10. Subjects with known active hepatitis B or hepatitis C infection.
11. Individuals who are judged by the Investigator to be unsuitable as study subjects.
12. Subjects who had prior wide-field radiotherapy affecting ≥ 20% of the bone marrow.

What this study is about

In the sponsor’s own words, from the registry.

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 sites(86)

Site 0170-USA Mitchell Cancer Institute
Mobile, Alabama, United States
Recruiting
Site 0143 - HonorHealth
Phoenix, Arizona, United States
Recruiting
Site 0102 - University of Arizona Cancer Center
Tucson, Arizona, United States
Recruiting
Site 0258 - UC San Diego Moores Cancer Center
La Jolla, California, United States
Active, not recruiting
Site 0287 - Ridley Tree Cancer Center
Santa Barbara, California, United States
Active, not recruiting
Site 0135 - Rocky Mountain Cancer Centers
Lone Tree, Colorado, United States
Recruiting
Site 0158 - Hartford HealthCare
Hartford, Connecticut, United States
Recruiting
Site 0241 - Florida Cancer Specialist - North
Altamonte Springs, Florida, United States
Recruiting
Site 0173 - Mount Sinai Medical Center
Miami Beach, Florida, United States
Recruiting
Site 0308 - Advent Health
Orlando, Florida, United States
Recruiting
Site 0239 - Florida Cancer Specialists - East
Wellington, Florida, United States
Recruiting
Site 0108 - Emory University Hospital
Atlanta, Georgia, United States
Recruiting
Site 0236 - Memorial Health
Savannah, Georgia, United States
Active, not recruiting
Site 0324 - Illinois Cancer Specialists
Niles, Illinois, United States
Active, not recruiting
Site 0284 - Community Cancer Center North
Indianapolis, Indiana, United States
Recruiting
Site 0217 - St Vincent Hospital and Health Care Centers
Indianapolis, Indiana, United States
Recruiting
Site 0251 - Norton Cancer Institute
Louisville, Kentucky, United States
Recruiting
Site 0146 - Maryland Oncology Hematology, PA
Rockville, Maryland, United States
Active, not recruiting
Site 0221 - Tufts Medical Center - PPDS
Boston, Massachusetts, United States
Recruiting
Site 0104 - Dana Farber Cancer Institute
Boston, Massachusetts, United States
Recruiting
Site 0307 - Lahey Hospital and Medical Center
Burlington, Massachusetts, United States
Recruiting
Site 0263 - Baystate Medical Center
Springfield, Massachusetts, United States
Recruiting
Site 0101 - Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Recruiting
Site 0228 - Corewell Health Medical Group West
Grand Rapids, Michigan, United States
Recruiting
Site 0288 - Minnesota Oncology Hematology - Maplewood
Maplewood, Minnesota, United States
Recruiting
Site 0226 - CoxHealth
Springfield, Missouri, United States
Active, not recruiting
Site 0317 - Nebraska Methodist Hospital
Omaha, Nebraska, United States
Active, not recruiting
Site 0213 - Center of Hope
Reno, Nevada, United States
Recruiting
Site 0231 - Northwell Health Cancer Institute
Manhasset, New York, United States
Active, not recruiting
Site 0126 - Wilmot Cancer Center
Rochester, New York, United States
Recruiting
Site 0259 - Duke Cancer Center
Durham, North Carolina, United States
Recruiting
Site 0147 - Trihealth Cancer Institute - Harold and Eugen
Cincinnati, Ohio, United States
Recruiting
Site 0243 - Mark H Zangmeister Cancer Center
Columbus, Ohio, United States
Recruiting
Site 0214-Ohio State University Comprehensive Cancer Center
Hilliard, Ohio, United States
Recruiting
Site 0316 - Willamette Valley Cancer Institute/Oncology Associates of Oregon
Eugene, Oregon, United States
Recruiting
Site 0232 - University of Pennsylvania
Philadelphia, Pennsylvania, United States
Recruiting
Site 0178 - Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Recruiting
Site 0277 - Alliance Cancer Specialist, PC
Wynnewood, Pennsylvania, United States
Active, not recruiting
Site 0132 - Avera Cancer Institute
Sioux Falls, South Dakota, United States
Recruiting
Site 0103 - University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Recruiting
Site 0203 - Texas Oncology
Tyler, Texas, United States
Recruiting
Site 0295 - Virginia Oncology Associates
Chesapeake, Virginia, United States
Recruiting
Site 0322 - Inova Schar Cancer Institute
Fairfax, Virginia, United States
Recruiting
Site 2715 - Icon Cancer Centre - Chermside
Chermside, Queensland, Australia
Recruiting
Site 2707 - Mater Brisbane
South Brisbane, Queensland, Australia
Recruiting
Site 2709 - Cancer Research SA
Adelaide, South Australia, Australia
Recruiting
Site 2702 - Burnside War Memorial Hospital - The Brian Fricker Oncology Centre
Toorak Gardens, South Australia, Australia
Recruiting
Site 2716 - Epworth Healthcare Freemasons
East Melbourne, Victoria, Australia
Recruiting
Site 2701 - Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia
Recruiting
Site 2717 - St John of God Hospital Subiaco
Subiaco, Western Australia, Australia
Recruiting
Site 3102 - Cliniques Universitaires Saint-Luc
Brussels, Brussels Capital, Belgium
Recruiting
Site 3105 - UZ Leuven
Leuven, Vlaams Brabant, Belgium
Recruiting
Site 3616 - Centre Antoine Lacassagne
Nice, Alpes-Maritimes, France
Recruiting
Site 3601 - Centre Georges François Leclerc
Dijon, Côte-d'Or, France
Recruiting
Site 3613 - CHRU Besancon - Hopital Jean Minjoz
Besançon, Doubs, France
Recruiting
Site 3617 - CHU de Brest - Hôpital La Cavale Blanche
Brest, Finistere, France
Recruiting
Site 3603 - Institut Claudius Regaud
Toulouse, Haute-Garonne, France
Recruiting
Site 3602 - Centre Oscar Lambret
Lille, Nord, France
Recruiting
Site 3615 - Hôpital Cochin Port-Royal AP-HP
Paris, Paris, France
Recruiting
Site 3614 - Institut de Cancerologie de l'oust
Saint-Herblain, Pays de la Loire Region, France
Recruiting

Showing 60 of 86 sites — filter to narrow it down. 77 of the 86 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT05128825. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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