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High-Grade Serous Ovarian, Fallopian Tube or Primary Peritoneal CancerPhase 2DENALINCT05128825

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

A Phase 2 study testing azenosertib in people with High-Grade Serous Ovarian, Fallopian Tube or Primary Peritoneal Cancer, run by K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc at 86 sites in 8 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
azenosertib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
310 participants
Where
86 sitesin 8 countries
Study dates
17 Feb 2022to 30 Jun 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
  • Subjects must have platinum-resistant disease
  • 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
Show all 12Show fewer
  • Prior bevacizumab treatment is required, if eligible per standard of care
  • Prior PARP inhibitor treatment is required if BRCA 1/2 mutation or HRD, if eligible per standard of care
  • 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

Who cannot join

  • 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:
  • Major surgery within 28 days
  • Hospitalization within 14 days
  • Any chemotherapy or targeted tumor therapy within 21 days or 5 half-lives (whichever is shorter);
Show all 26Show fewer
  • Radiation therapy within 21 days;
  • Autologous or allogeneic stem cell transplant within 3 months.
  • Current use of any other investigational drug therapy <28 days or 5 half-lives (whichever is shorter).
  • 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:
  • Clinically or radiographically unstable brain metastases or leptomeningeal disease that requires immediate treatment. Subjects with asymptomatic brain metastases are eligible.
  • Myocardial impairment resulting in heart failure (NYHA Class II-IV)
  • 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
  • Acute kidney injury requiring intervention or intravenous fluid in the last 14 days or presence of indwelling urinary catheter or percutaneous nephrostomy.
  • 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.
  • 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
  • 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.

Trial locations and contacts

86 sites in 8 countries. Contact the study team or a site near you to ask about taking part.

Project Director contact

858.263.4333

medicalaffairs@zentalis.com

86 sites in 8 countries

United States43 sites, 34 recruiting

  • Site 0241 - Florida Cancer Specialist - North

    Altamonte Springs, Florida, 32701

    Recruiting

  • Site 0108 - Emory University Hospital

    Atlanta, Georgia, 30322

    Recruiting

  • Site 0221 - Tufts Medical Center - PPDS

    Boston, Massachusetts, 02111

    Recruiting

  • Site 0104 - Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

    Recruiting

  • Site 0307 - Lahey Hospital and Medical Center

    Burlington, Massachusetts, 01805

    Recruiting

  • Site 0295 - Virginia Oncology Associates

    Chesapeake, Virginia, 23320

    Recruiting

  • Site 0147 - Trihealth Cancer Institute - Harold and Eugen

    Cincinnati, Ohio, 45242

    Recruiting

  • Site 0243 - Mark H Zangmeister Cancer Center

    Columbus, Ohio, 43219

    Recruiting

  • Site 0101 - Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201

    Robert Morris

    Recruiting

  • Site 0259 - Duke Cancer Center

    Durham, North Carolina, 27710

    Recruiting

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

    Eugene, Oregon, 97401

    Recruiting

  • Site 0322 - Inova Schar Cancer Institute

    Fairfax, Virginia, 22031

    Recruiting

  • Site 0228 - Corewell Health Medical Group West

    Grand Rapids, Michigan, 49503

    Recruiting

  • Site 0158 - Hartford HealthCare

    Hartford, Connecticut, 06106

    Recruiting

  • Site 0214-Ohio State University Comprehensive Cancer Center

    Hilliard, Ohio, 43026

    Recruiting

  • Site 0103 - University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

    Recruiting

  • Site 0284 - Community Cancer Center North

    Indianapolis, Indiana, 46250

    Recruiting

  • Site 0217 - St Vincent Hospital and Health Care Centers

    Indianapolis, Indiana, 46260

    Recruiting

  • Site 0258 - UC San Diego Moores Cancer Center

    La Jolla, California, 92037

    Active, not recruiting

  • Site 0135 - Rocky Mountain Cancer Centers

    Lone Tree, Colorado, 80218

    Recruiting

  • Site 0251 - Norton Cancer Institute

    Louisville, Kentucky, 40202

    Recruiting

  • Site 0231 - Northwell Health Cancer Institute

    Manhasset, New York, 11030

    Active, not recruiting

  • Site 0288 - Minnesota Oncology Hematology - Maplewood

    Maplewood, Minnesota, 55109

    Recruiting

  • Site 0173 - Mount Sinai Medical Center

    Miami Beach, Florida, 33140

    Recruiting

  • Site 0170-USA Mitchell Cancer Institute

    Mobile, Alabama, 36604

    Recruiting

  • Site 0324 - Illinois Cancer Specialists

    Niles, Illinois, 60714

    Active, not recruiting

  • Site 0317 - Nebraska Methodist Hospital

    Omaha, Nebraska, 68114

    Active, not recruiting

  • Site 0308 - Advent Health

    Orlando, Florida, 32803

    Recruiting

  • Site 0232 - University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

    Recruiting

  • Site 0178 - Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

    Recruiting

  • Site 0143 - HonorHealth

    Phoenix, Arizona, 85016

    Recruiting

  • Site 0213 - Center of Hope

    Reno, Nevada, 89511

    Recruiting

  • Site 0126 - Wilmot Cancer Center

    Rochester, New York, 14642

    Recruiting

  • Site 0146 - Maryland Oncology Hematology, PA

    Rockville, Maryland, 20876

    Active, not recruiting

  • Site 0287 - Ridley Tree Cancer Center

    Santa Barbara, California, 93105

    Active, not recruiting

  • Site 0236 - Memorial Health

    Savannah, Georgia, 31404

    Active, not recruiting

  • Site 0132 - Avera Cancer Institute

    Sioux Falls, South Dakota, 57105

    Recruiting

  • Site 0263 - Baystate Medical Center

    Springfield, Massachusetts, 01199

    Recruiting

  • Site 0226 - CoxHealth

    Springfield, Missouri, 65807

    Active, not recruiting

  • Site 0102 - University of Arizona Cancer Center

    Tucson, Arizona, 85724

    Recruiting

  • Site 0203 - Texas Oncology

    Tyler, Texas, 75702

    Recruiting

  • Site 0239 - Florida Cancer Specialists - East

    Wellington, Florida, 33414

    Recruiting

  • Site 0277 - Alliance Cancer Specialist, PC

    Wynnewood, Pennsylvania, 19096

    Active, not recruiting

Other trials in United States

France12 sites, 12 recruiting

  • Site 3613 - CHRU Besancon - Hopital Jean Minjoz

    Besançon, Doubs, 25030

    Recruiting

  • Site 3617 - CHU de Brest - Hôpital La Cavale Blanche

    Brest, Finistere, 29200

    Recruiting

  • Site 3601 - Centre Georges François Leclerc

    Dijon, Côte-d'Or, 21079

    Recruiting

  • Site 3602 - Centre Oscar Lambret

    Lille, Nord, 59000

    Recruiting

  • Site 3619 - Centre Léon Bérard

    Lyon, 69373

    Recruiting

  • Site 3616 - Centre Antoine Lacassagne

    Nice, Alpes-Maritimes, 06100

    Recruiting

  • Site 3615 - Hôpital Cochin Port-Royal AP-HP

    Paris, Paris, 75181

    Recruiting

  • Site 3608 - Hospices Civils de Lyon - Hôpital Lyon Sud

    Pierre-Bénite, Rhône, 69310

    Recruiting

  • Site 3614 - Institut de Cancerologie de l'oust

    Saint-Herblain, Pays de la Loire Region, 44800

    Recruiting

  • Site 3620 - CHU de Strasbourg - Hopital de Hautepierre

    Strasbourg, 67200

    Recruiting

  • Site 3603 - Institut Claudius Regaud

    Toulouse, Haute-Garonne, 31000

    Recruiting

  • Site 3604 - Institut Gustave Roussy

    Villejuif, 94800

    Recruiting

Other trials in France

Italy8 sites, 8 recruiting

  • Site 3312 - Centro di Riferimento Oncologico

    Aviano, Friuli Venezia Giulia, 33081

    Recruiting

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

    Bologna, 40138

    Recruiting

  • Site 3305 - Istituto Europeo di Oncologia

    Milan, Lombardy, 20141

    Recruiting

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

    Milan, Milano, 20132

    Recruiting

  • Site 3308 - Azienda Ospedaliero Universitaria Di Modena Policlinico

    Modena, Emilia-Romagna, 41124

    Recruiting

  • Site 3302 - Istituto Nazionale Tumori IRCCS Fondazione Giovanni Pascale

    Naples, Campania, 80131

    Recruiting

  • Site 3304 - Fondazione Policlinico Universitario A Gemelli

    Rome, Lazio, 168

    Recruiting

  • Site 3311 - Azienda Ospedaliera Universitaria Integrata Di Verona

    Verona, Veneto, 37126

    Recruiting

Other trials in Italy

Australia7 sites, 7 recruiting

  • Site 2709 - Cancer Research SA

    Adelaide, South Australia, 5037

    Recruiting

  • Site 2715 - Icon Cancer Centre - Chermside

    Chermside, Queensland, 4032

    Recruiting

  • Site 2716 - Epworth Healthcare Freemasons

    East Melbourne, Victoria, 3002

    Recruiting

  • Site 2701 - Sir Charles Gairdner Hospital

    Nedlands, Western Australia, 6009

    Recruiting

  • Site 2707 - Mater Brisbane

    South Brisbane, Queensland, 4101

    Recruiting

  • Site 2717 - St John of God Hospital Subiaco

    Subiaco, Western Australia, 6008

    Recruiting

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

    Toorak Gardens, South Australia, 5065

    Recruiting

Other trials in Australia

South Korea6 sites, 6 recruiting

  • Site 2908 - National Cancer Center

    Goyang-si, Gyeonggi-do, 10408

    Recruiting

  • Site 2905 - Seoul National University Hospital

    Seoul, 03080

    Recruiting

  • Site 2909 - Severance Hospital Yonsei University Health System

    Seoul, 03722

    Recruiting

  • Site 2904 - Asan Medical Center

    Seoul, 05505

    Recruiting

  • Site 2906 - Gangnam Severance Hospital, Yonsei University Health System

    Seoul, 06273

    Recruiting

  • Site 2907 - Samsung Medical Center

    Seoul, 06351

    Recruiting

Other trials in South Korea

Spain5 sites, 5 recruiting

  • Site 3511 - Instituto de Investigacion Oncologica Vall d'Hebron

    Barcelona, Barcelona, 8035

    Recruiting

  • Site 3517 - Clinica Universidad de Navarra

    Madrid, Madrid, 28027

    Recruiting

  • Site 3502 - Hospital Universitario La Paz

    Madrid, 28046

    Recruiting

  • Site 3516 - Hospital Universitario Virgen de La Arrixaca

    Murcia, Murcia, 30120

    Recruiting

  • Site 3501 - Hospital Clinico Universitario de Valencia

    Valencia, Valencia, 46010

    Recruiting

Other trials in Spain

Poland3 sites, 3 recruiting

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

    Bialystok, Podlaskie Voivodeship, 15-027

    Recruiting

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

    Gdynia, Pomeranian Voivodeship, 81-519

    Recruiting

  • Site 2405 - Centrum Badan Klinicznych JCI

    Krakow, Lesser Poland Voivodeship, 30-348

    Recruiting

Other trials in Poland

Belgium2 sites, 2 recruiting

  • Site 3102 - Cliniques Universitaires Saint-Luc

    Brussels, Brussels Capital, 1200

    Recruiting

  • Site 3105 - UZ Leuven

    Leuven, Vlaams Brabant, 3000

    Recruiting

Other trials in Belgium

About this study

Official title: 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.

Read the detailed description

A 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. 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

Being tested
azenosertib
Keywords
Cyclin E1, CCNE1, Ovarian Cancer, Platinum Resistant, WEE1 inhibitor, DENALI, GOG-3066
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • azenosertibDrug

    Also called ZN-c3

    Azenosertib (ZN-c3) will be administered orally.

Study groups in NCT05128825
Study groupRoleWhat they receive
Part 1a/1b (Completed Enrollment)ExperimentalAzenosertib 400mg administered once daily on a 5 days on, 2 days off intermittent schedule.
Receives: Drug: azenosertib
Part 2a: Arm 1 (Completed Enrollment)ExperimentalAzenosertib 400mg administered once daily on a 5 days on, 2 days off intermittent schedule
Receives: Drug: azenosertib
Part 2a: Arm 2 (Completed Enrollment)ExperimentalAzenosertib 300mg administered once daily on a 5 days on, 2 days off intermittent schedule
Receives: Drug: azenosertib
Part 2b (Completed Enrollment)ExperimentalAzenosertib 400mg administered once daily on a 5 days on, 2 days off intermittent schedule
Receives: Drug: azenosertib
Part 2c (Enrolling)ExperimentalAzenosertib 400mg administered once daily on a 5 days on, 2 days off intermittent schedule
Receives: Drug: azenosertib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate (ORR) defined by RECIST v1.1 [Part 2]

    Participants who achieve partial response (PR) or complete response (CR) per RECIST v1.1 criteria.

    Measured: Up to approximately 12 months from the enrollment of the last subject

Secondary outcomes (5)

  1. Duration of response (DOR) defined by RECIST v1.1 [Part 2]

    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.

    Measured: Up to approximately 12 months from the enrollment of the last subject

  2. Progression free survival (PFS) defined by RECIST v1.1 [Part 2]

    Time from the date of first dose until the date of PD or death.

    Measured: Up to approximately 12 months from the enrollment of the last subject

  3. Clinical Benefit Rate (CBR) defined by RECIST v1.1 [Part 2]

    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.

    Measured: Up to approximately 12 months from the enrollment of the last subject

  4. CA-125 response by GCIG criteria [Part 2]

    The GCIG CA-125 response was defined as at least 50% reduction in CA-125 levels from baseline.

    Measured: Up to approximately 12 months from the enrollment of the last subject

  5. Number of Subjects experiencing treatment emergent adverse events (TEAEs) [Part 2]

    Measured: Up to approximately 12 months from the enrollment of the last subject

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Nov 2021
  2. Study start17 Feb 2022
  3. Primary completion1 Dec 2026 (estimated)
  4. Study completion30 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Part 1a/1b (Arm completed enrollment); Part 2a-Arm 1 (Arm completed enrollment); Part 2a-Arm 2 (Arm completed enrollment); Part 2b (Arm completed enrollment); Part 2c (Enrolling)
Masking
None (open label)
Enrolment
310 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05128825
Sponsor's protocol ID
ZN-c3-005
Acronym
DENALI
Status last verified
Sep 2026
First submitted
28 Oct 2021
Last updated
29 Sep 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing azenosertib in people with High-Grade Serous Ovarian, Fallopian Tube or Primary Peritoneal Cancer, run by K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc at 86 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 86 sites in United States, France, Italy, Australia, South Korea and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Project Director (858.263.4333, medicalaffairs@zentalis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05128825.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.

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