ClinicalTrials.gg
RecruitingNCT05128825DENALIUpdated Oct 30, 2026

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

A Phase 2 interventional study of azenosertib in High-Grade Serous Ovarian, Fallopian Tube or Primary Peritoneal Cancer, sponsored by K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc. Recruiting at 89 sites in 9 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-30.

Sponsored by K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Feb 2022; still recruiting 4 years 8 months later.
Updated Oct 30, 2026First site in Puerto RicoEligibility revised+3 moreGo to Updates ↓

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Phase
Phase 2
Study type
Interventional
Enrollment
310
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 1,778 studies in Ovarian Neoplasms with a site in United States — 280 open to participants now, 455 under way, 46 of them phase 3. Ovarian Neoplasms · United States.

Planned enrollment
180th of 1,497
310 · median 47
Started
2022
with 75 others
Phase 2
485 of 1,778
53 open now
Primary completion
2026-12
later than 116 of 453 live
Registered
1,416th of 1,778
by date

Among the 1,778 studies in Ovarian Neoplasms with a site in United States, this one is the 180th largest by planned enrollment of the 1,497 interventional ones that give a count, is one of 76 that started in 2022, is one of 485 in phase 2, reaches primary completion later than 116 of the 453 other live ones, and was the 1,416th registered.

Ovarian Neoplasms

3,385 studies on the registry are indexed under Ovarian Neoplasms; 792 are open to participants now.

Browse Ovarian Neoplasms studies →

Open to participants now

280 of the 1,778 studies in Ovarian Neoplasms with a site in United States are open now. Recruiting first, the newest first:

275 more — sign in →

All 280 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 605 Ovarian Neoplasms studies recruiting now, 442 (73%) set no upper age limit and 107 (18%) stop at 75 or younger; 39 take children under 18; 45 take healthy volunteers.

This study: 18 Years and older · female · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 1,778 studies in Ovarian Neoplasms with a site in United States, or all of them as a file.
02

Study 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. 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

03

Conditions studied

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

Browse trials for

Keywords

  • Cyclin E1, CCNE1, Ovarian Cancer, Platinum Resistant, WEE1 inhibitor, DENALI, GOG-3066
04

Who can participate

The criteria were revised on the registry on Sep 29, 2026. See what changed

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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. per Version 1.1.
  6. Adequate hematologic and organ function, as defined in protocol
  7. 0-1

Exclusion criteria

Exclusion Criteria:

  1. Primary platinum- 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. or allogeneic stem cell transplant within 3 months.
    6. Current use of any other 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 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 or that requires immediate treatment. Subjects with asymptomatic brain metastases are eligible.
    2. Myocardial impairment resulting in heart failure ( 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 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 who has a positive serum pregnancy test within 14 days prior to C1D1.
  8. History of another 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 or -positive on highly active anti-retroviral therapy.
  10. Subjects with known active or 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.
Terms in these criteria, in plain language(17)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

RECIST

The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.

“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

Allogeneic and autologous transplant

Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.

CYP3A (CYP3A4) inhibitors and inducers

CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.

Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.

Brain metastases

Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).

Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.

Leptomeningeal disease

Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.

Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
310 participants (estimated)

Study arms

  • Experimental
    Part 1a/1b (Completed Enrollment)

    Azenosertib 400mg administered once daily on a 5 days on, 2 days off intermittent schedule.

    Drug: azenosertib

  • Experimental
    Part 2a: Arm 1 (Completed Enrollment)

    Azenosertib 400mg administered once daily on a 5 days on, 2 days off intermittent schedule

    Drug: azenosertib

  • Experimental
    Part 2a: Arm 2 (Completed Enrollment)

    Azenosertib 300mg administered once daily on a 5 days on, 2 days off intermittent schedule

    Drug: azenosertib

  • Experimental
    Part 2b (Completed Enrollment)

    Azenosertib 400mg administered once daily on a 5 days on, 2 days off intermittent schedule

    Drug: azenosertib

  • Experimental
    Part 2c (Enrolling)

    Azenosertib 400mg administered once daily on a 5 days on, 2 days off intermittent schedule

    Drug: azenosertib

Interventions

  • Azenosertib (ZN-c3) will be administered orally.

    Also known as: ZN-c3

06

What researchers measure

Primary outcomes

  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.

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

Secondary outcomes

  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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

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

  5. 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

07

Study locations

80 of 89 sites recruiting
  • Site 0170-USA Mitchell Cancer Institute
    Mobile, Alabama 36604, United States
    Recruiting
  • Site 0143 - HonorHealth
    Phoenix, Arizona 85016, United States
    Recruiting
  • Site 0102 - University of Arizona Cancer Center
    Tucson, Arizona 85724, United States
    Recruiting
  • Site 0258 - UC San Diego Moores Cancer Center
    La Jolla, California 92037, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Site 0287 - Ridley Tree Cancer Center
    Santa Barbara, California 93105, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Site 0135 - Rocky Mountain Cancer Centers
    Lone Tree, Colorado 80218, United States
    Recruiting
  • Site 0158 - Hartford HealthCare
    Hartford, Connecticut 06106, United States
    Recruiting
  • Site 0241 - Florida Cancer Specialist - North
    Altamonte Springs, Florida 32701, United States
    Recruiting
  • Site 0173 - Mount Sinai Medical Center
    Miami Beach, Florida 33140, United States
    Recruiting
  • Site 0308 - Advent Health
    Orlando, Florida 32803, United States
    Recruiting
  • Site 0239 - Florida Cancer Specialists - East
    Wellington, Florida 33414, United States
    Recruiting
  • Site 0108 - Emory University Hospital
    Atlanta, Georgia 30322, United States
    Recruiting
  • Site 0236 - Memorial Health
    Savannah, Georgia 31404, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Site 0324 - Illinois Cancer Specialists
    Niles, Illinois 60714, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Site 0284 - Community Cancer Center North
    Indianapolis, Indiana 46250, United States
    Recruiting
  • Site 0217 - St Vincent Hospital and Health Care Centers
    Indianapolis, Indiana 46260, United States
    Recruiting
  • Site 0251 - Norton Cancer Institute
    Louisville, Kentucky 40202, United States
    Recruiting
  • Site 0146 - Maryland Oncology Hematology, PA
    Rockville, Maryland 20876, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Site 0221 - Tufts Medical Center - PPDS
    Boston, Massachusetts 02111, United States
    Recruiting
  • Site 0104 - Dana Farber Cancer Institute
    Boston, Massachusetts 02215, United States
    Recruiting
  • Site 0307 - Lahey Hospital and Medical Center
    Burlington, Massachusetts 01805, United States
    Recruiting
  • Site 0263 - Baystate Medical Center
    Springfield, Massachusetts 01199, United States
    Recruiting
  • Site 0101 - Barbara Ann Karmanos Cancer Institute
    Detroit, Michigan 48201, United States
    Recruiting
    • Robert Morris · Principal investigator
  • Site 0228 - Corewell Health Medical Group West
    Grand Rapids, Michigan 49503, United States
    Recruiting
  • Site 0288 - Minnesota Oncology Hematology - Maplewood
    Maplewood, Minnesota 55109, United States
    Recruiting
  • Site 0226 - CoxHealth
    Springfield, Missouri 65807, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Site 0317 - Nebraska Methodist Hospital
    Omaha, Nebraska 68114, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Site 0213 - Center of Hope
    Reno, Nevada 89511, United States
    Recruiting
  • Site 0231 - Northwell Health Cancer Institute
    Manhasset, New York 11030, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Site 0126 - Wilmot Cancer Center
    Rochester, New York 14642, United States
    Recruiting
  • Site 0259 - Duke Cancer Center
    Durham, North Carolina 27710, United States
    Recruiting
  • Site 0147 - Trihealth Cancer Institute - Harold and Eugen
    Cincinnati, Ohio 45242, United States
    Recruiting
  • Site 0243 - Mark H Zangmeister Cancer Center
    Columbus, Ohio 43219, United States
    Recruiting
  • Site 0214-Ohio State University Comprehensive Cancer Center
    Hilliard, Ohio 43026, United States
    Recruiting
  • Site 0316 - Willamette Valley Cancer Institute/Oncology Associates of Oregon
    Eugene, Oregon 97401, United States
    Recruiting
  • Site 0232 - University of Pennsylvania
    Philadelphia, Pennsylvania 19104, United States
    Recruiting
  • Site 0178 - Thomas Jefferson University
    Philadelphia, Pennsylvania 19107, United States
    Recruiting
  • Site 0277 - Alliance Cancer Specialist, PC
    Wynnewood, Pennsylvania 19096, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Site 0132 - Avera Cancer Institute
    Sioux Falls, South Dakota 57105, United States
    Recruiting
  • Site 0103 - University of Texas MD Anderson Cancer Center
    Houston, Texas 77030, United States
    Recruiting
  • Site 0203 - Texas Oncology
    Tyler, Texas 75702, United States
    Recruiting
  • Site 0295 - Virginia Oncology Associates
    Chesapeake, Virginia 23320, United States
    Recruiting
  • Site 0322 - Inova Schar Cancer Institute
    Fairfax, Virginia 22031, United States
    Recruiting
  • Site 2715 - Icon Cancer Centre - Chermside
    Chermside, Queensland 4032, Australia
    Recruiting
  • Site 2707 - Mater Brisbane
    South Brisbane, Queensland 4101, Australia
    Recruiting
  • Site 2709 - Cancer Research SA
    Adelaide, South Australia 5037, Australia
    Recruiting
  • Site 2702 - Burnside War Memorial Hospital - The Brian Fricker Oncology Centre
    Toorak Gardens, South Australia 5065, Australia
    Recruiting
  • Site 2716 - Epworth Healthcare Freemasons
    East Melbourne, Victoria 3002, Australia
    Recruiting
  • Site 2701 - Sir Charles Gairdner Hospital
    Nedlands, Western Australia 6009, Australia
    Recruiting
  • Site 2717 - St John of God Hospital Subiaco
    Subiaco, Western Australia 6008, Australia
    Recruiting
  • Site 3102 - Cliniques Universitaires Saint-Luc
    Brussels, Brussels Capital 1200, Belgium
    Recruiting
  • Site 3105 - UZ Leuven
    Leuven, Vlaams Brabant 3000, Belgium
    Recruiting
  • Site 3616 - Centre Antoine Lacassagne
    Nice, Alpes-Maritimes 06100, France
    Recruiting
  • Site 3601 - Centre Georges François Leclerc
    Dijon, Côte-d'Or 21079, France
    Recruiting
  • Site 3613 - CHRU Besancon - Hopital Jean Minjoz
    Besançon, Doubs 25030, France
    Recruiting
  • Site 3617 - CHU de Brest - Hôpital La Cavale Blanche
    Brest, Finistere 29200, France
    Recruiting
  • Site 3603 - Institut Claudius Regaud
    Toulouse, Haute-Garonne 31000, France
    Recruiting
  • Site 3602 - Centre Oscar Lambret
    Lille, Nord 59000, France
    Recruiting
  • Site 3615 - Hôpital Cochin Port-Royal AP-HP
    Paris, Paris 75181, France
    Recruiting
  • Site 3614 - Institut de Cancerologie de l'oust
    Saint-Herblain, Pays de la Loire Region 44800, France
    Recruiting
  • Site 3608 - Hospices Civils de Lyon - Hôpital Lyon Sud
    Pierre-Bénite, Rhône 69310, France
    Recruiting
  • Site 3619 - Centre Léon Bérard
    Lyon, 69373, France
    Recruiting
  • Site 3620 - CHU de Strasbourg - Hopital de Hautepierre
    Strasbourg, 67200, France
    Recruiting
  • Site 3604 - Institut Gustave Roussy
    Villejuif, 94800, France
    Recruiting
  • Site 3302 - Istituto Nazionale Tumori IRCCS Fondazione Giovanni Pascale
    Naples, Campania 80131, Italy
    Recruiting
  • Site 3308 - Azienda Ospedaliero Universitaria Di Modena Policlinico
    Modena, Emilia-Romagna 41124, Italy
    Recruiting
  • Site 3312 - Centro di Riferimento Oncologico
    Aviano, Friuli Venezia Giulia 33081, Italy
    Recruiting
  • Site 3304 - Fondazione Policlinico Universitario A Gemelli
    Rome, Lazio 168, Italy
    Recruiting
  • Site 3305 - Istituto Europeo di Oncologia
    Milan, Lombardy 20141, Italy
    Recruiting
  • Site 3314 - Humanitas San Pio X
    Milan, Lombardy 20159, Italy
    Recruiting
  • Site 3307 - Ospedale San Raffaele S.r.l.
    Milan, Milano 20132, Italy
    Recruiting
  • Site 3311 - Azienda Ospedaliera Universitaria Integrata Di Verona
    Verona, Veneto 37126, Italy
    Recruiting
  • Site 3303 - Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi-Via Massarenti
    Bologna, 40138, Italy
    Recruiting
  • Site 2405 - Centrum Badan Klinicznych JCI
    Krakow, Lesser Poland Voivodeship 30-348, Poland
    Recruiting
  • Site 2419 - Bialostockie Centrum Onkologii im. Marii Sklodowskiej-Curie w Bialymstoku
    Bialystok, Podlaskie Voivodeship 15-027, Poland
    Recruiting
  • Site 2421 - Szpitale Pomorskie Sp. z o. o.
    Gdynia, Pomeranian Voivodeship 81-519, Poland
    Recruiting
  • Site 0326 - Pan American Center for Oncology Trials LLC
    San Juan, Puerto Rico 935, Puerto Rico
    Recruiting
  • Site 2908 - National Cancer Center
    Goyang-si, Gyeonggi-do 10408, South Korea
    Recruiting
  • Site 2905 - Seoul National University Hospital
    Seoul, 03080, South Korea
    Recruiting
  • Site 2909 - Severance Hospital Yonsei University Health System
    Seoul, 03722, South Korea
    Recruiting
  • Site 2904 - Asan Medical Center
    Seoul, 05505, South Korea
    Recruiting
  • Site 2906 - Gangnam Severance Hospital, Yonsei University Health System
    Seoul, 06273, South Korea
    Recruiting
  • Site 2907 - Samsung Medical Center
    Seoul, 06351, South Korea
    Recruiting
  • Site 3511 - Instituto de Investigacion Oncologica Vall d'Hebron
    Barcelona, Barcelona 8035, Spain
    Recruiting
  • Site 3517 - Clinica Universidad de Navarra
    Madrid, Madrid 28027, Spain
    Recruiting
  • Site 3519 - Hospital Universitario Puerta de Hierro
    Majadahonda, Madrid 28222, Spain
    Recruiting
  • Site 3516 - Hospital Universitario Virgen de La Arrixaca
    Murcia, Murcia 30120, Spain
    Recruiting
  • Site 3501 - Hospital Clinico Universitario de Valencia
    Valencia, Valencia 46010, Spain
    Recruiting
  • Site 3502 - Hospital Universitario La Paz
    Madrid, 28046, Spain
    Recruiting
08

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Feb 2022 (actual). Primary completion is estimated for Dec 2026, 57 months after the start.

Of 116 industry-sponsored phase 2 interventional studies under Ovarian Neoplasms, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 51. This study's planned 57 months is above that.

Counting every sponsor, half of 344 studies reached it within 47 months; a quarter within 33 and three quarters within 72.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 28, 2021
First posted
Nov 22, 2021
StartActual
Feb 17, 2022
Primary completionEst.
Dec 1, 2026
CompletionEst.
Jun 30, 2027
Last update
Oct 30, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Sites
5 sites added, 8 sites removed — first site in Puerto Rico
Show 5 added (2 United States, 1 Italy, 1 Puerto Rico, 1 Spain)
  • Site 0241 - Florida Cancer Specialist - North · Altamonte Springs, United States
  • Site 0239 - Florida Cancer Specialists - East · Wellington, United States
  • Site 3314 - Humanitas San Pio X · Milan, Italy
  • Site 0326 - Pan American Center for Oncology Trials LLC · San Juan, Puerto Rico
  • Site 3519 - Hospital Universitario Puerta de Hierro · Majadahonda, Spain
Show 8 removed
  • Site 0239 - Florida Cancer Specialists - East · Daytona Beach, United States
  • Site 0241 - Florida Cancer Specialist - North · Lecanto, United States
  • Site 0234 - University of Texas Health, Memorial Hermann Hospital · Houston, United States
  • Site 0323 - Compass Oncology · Vancouver, United States
  • Site 3101 - AZORG - Aalst · Aalst, Belgium
  • Site 3611 - ICANS - Institut de cancérologie Strasbourg Europe · Strasbourg, France
  • Site 2414 - Med-Polonia Sp. z o.o. · Poznan, Poland
  • Site 2404 - Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie · Warsaw, Poland
across 2 updates, Sep 29, 2026 – Oct 30, 2026
Eligibility
1 inclusion criterion removed
What changed in the criteria
Inclusion criteria
  • RemovedParts 2a and 2b: One to 3 prior lines or regimens are allowed (1 to 4 prior lines are permitted, if prior mirvetuximab)
Sep 29, 2026
Interventions
Arms added: Part 2b (Completed Enrollment)·Part 2c (Enrolling); arms removed: Part 2b·Part 2c
Sep 29, 2026
Show all 2 updates
  1. Oct 30, 2026
    3 sites added — first site in Puerto Rico
    Show 3 added (1 Italy, 1 Puerto Rico, 1 Spain)
    • Site 3314 - Humanitas San Pio X · Milan, Italy
    • Site 0326 - Pan American Center for Oncology Trials LLC · San Juan, Puerto Rico
    • Site 3519 - Hospital Universitario Puerta de Hierro · Majadahonda, Spain
    + 1 other change: verification date
  2. Sep 29, 2026
    2 sites added, 8 sites removed
    Show 2 added (2 United States)
    • Site 0241 - Florida Cancer Specialist - North · Altamonte Springs, United States
    • Site 0239 - Florida Cancer Specialists - East · Wellington, United States
    Show 8 removed
    • Site 0239 - Florida Cancer Specialists - East · Daytona Beach, United States
    • Site 0241 - Florida Cancer Specialist - North · Lecanto, United States
    • Site 0234 - University of Texas Health, Memorial Hermann Hospital · Houston, United States
    • Site 0323 - Compass Oncology · Vancouver, United States
    • Site 3101 - AZORG - Aalst · Aalst, Belgium
    • Site 3611 - ICANS - Institut de cancérologie Strasbourg Europe · Strasbourg, France
    • Site 2414 - Med-Polonia Sp. z o.o. · Poznan, Poland
    • Site 2404 - Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie · Warsaw, Poland
    Eligibility 1 inclusion criterion removed
    What changed in the criteria
    Inclusion criteria
    • RemovedParts 2a and 2b: One to 3 prior lines or regimens are allowed (1 to 4 prior lines are permitted, if prior mirvetuximab)
    Interventions Arms added: Part 2b (Completed Enrollment)·Part 2c (Enrolling); arms removed: Part 2b·Part 2c
    + 3 other changes: verification date, description and design details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT05128825
Lead sponsor
K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc
Responsible party
Sponsor
First posted
Nov 22, 2021
Start date
Feb 17, 2022
Primary completion
Dec 1, 2026 (estimated)
Completion
Jun 30, 2027 (estimated)
Last update
Oct 30, 2026

Study contacts

Project Director
Contact
medicalaffairs@zentalis.com
858.263.4333

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Azenosertib

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