New hope for drug-resistant ovarian cancer: experimental pill targets tumor weakness

NCT ID NCT05128825

Disease control Sponsor: K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jul 02, 2026 · Updated 2 times

Summary

This study tests an experimental drug called azenosertib (ZN-c3) in people with a specific type of ovarian, fallopian tube, or peritoneal cancer that no longer responds to platinum chemotherapy. The drug aims to shrink or control tumors by blocking a protein that cancer cells need to grow. About 310 adults with Cyclin E1 positive tumors will take part to see if the drug is safe and effective.

Why investors are watching

Zentalis Pharmaceuticals is running a Phase 2 trial of its drug azenosertib (ZN-c3) in patients with platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer. The trial focuses on patients whose tumors are Cyclin E1 positive, a biomarker that may predict response. For a small company like Zentalis, this readout is a key test of whether its lead drug works in a hard-to-treat cancer, which could shape the company's future value.

If it works: If the trial shows that azenosertib controls the disease in these patients, Zentalis could have a viable treatment option for a cancer with few choices. A positive result might support further development and eventual regulatory approval, giving the company a commercial product.

If it fails: Phase 2 trials often fail to meet their goals, and this one could show the drug does not work or causes unacceptable side effects. A failure or delay could hurt Zentalis's prospects, since the company's value depends heavily on this drug's success.

AI-written from the trial record. Speculative, and not investment advice.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 310 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2022

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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. 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 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.

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Conditions

The condition(s) this trial relates to.

fallopian tube serous adenocarcinoma ovarian cancer ovarian carcinoma ovarian serous adenocarcinoma primary peritoneal carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

High-grade serous ovarian, fallopian tube or primary peritoneal cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

The study's own enquiry address

This study publishes an address for enquiries. See it below .
The places running it

78 sites in 8 countries. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Show contact details

Study contacts

Contact

Email: •••••@•••••

Locations

Site 0101 - Barbara Ann Karmanos Cancer Institute
RECRUITING

Detroit, Michigan, 48201, United States
Site 0102 - University of Arizona Cancer Center
RECRUITING

Tucson, Arizona, 85724, United States
Site 0103 - University of Texas MD Anderson Cancer Center
RECRUITING

Houston, Texas, 77030, United States
Site 0104 - Dana Farber Cancer Institute
RECRUITING

Boston, Massachusetts, 02215, United States
Site 0108 - Emory University Hospital
RECRUITING

Atlanta, Georgia, 30322, United States
Site 0126 - Wilmot Cancer Center
RECRUITING

Rochester, New York, 14642, United States
Site 0132 - Avera Cancer Institute
RECRUITING

Sioux Falls, South Dakota, 57105, United States
Site 0135 - Rocky Mountain Cancer Centers
RECRUITING

Lone Tree, Colorado, 80218, United States
Site 0143 - HonorHealth
RECRUITING

Phoenix, Arizona, 85016, United States
Site 0146 - Maryland Oncology Hematology, PA
ACTIVE_NOT_RECRUITING

Rockville, Maryland, 20876, United States
Site 0147 - Trihealth Cancer Institute - Harold and Eugen
RECRUITING

Cincinnati, Ohio, 45242, United States
Site 0158 - Hartford HealthCare
RECRUITING

Hartford, Connecticut, 06106, United States
Site 0170-USA Mitchell Cancer Institute
RECRUITING

Mobile, Alabama, 36604, United States
Site 0173 - Mount Sinai Medical Center
RECRUITING

Miami Beach, Florida, 33140, United States
Site 0178 - Thomas Jefferson University
RECRUITING

Philadelphia, Pennsylvania, 19107, United States
Site 0203 - Texas Oncology
RECRUITING

Tyler, Texas, 75702, United States
Site 0213 - Center of Hope
RECRUITING

Reno, Nevada, 89511, United States
Site 0214-Ohio State University Comprehensive Cancer Center
RECRUITING

Hilliard, Ohio, 43026, United States
Site 0217 - St Vincent Hospital and Health Care Centers
RECRUITING

Indianapolis, Indiana, 46260, United States
Site 0221 - Tufts Medical Center - PPDS
RECRUITING

Boston, Massachusetts, 02111, United States
Site 0226 - CoxHealth
ACTIVE_NOT_RECRUITING

Springfield, Missouri, 65807, United States
Site 0228 - Corewell Health Medical Group West
RECRUITING

Grand Rapids, Michigan, 49503, United States
Site 0231 - Northwell Health Cancer Institute
ACTIVE_NOT_RECRUITING

Manhasset, New York, 11030, United States
Site 0232 - University of Pennsylvania
RECRUITING

Philadelphia, Pennsylvania, 19104, United States
Site 0234 - University of Texas Health, Memorial Hermann Hospital
ACTIVE_NOT_RECRUITING

Houston, Texas, 77030, United States
Site 0236 - Memorial Health
ACTIVE_NOT_RECRUITING

Savannah, Georgia, 31404, United States
Site 0239 - Florida Cancer Specialists - East
RECRUITING

Daytona Beach, Florida, 32117, United States
Site 0241 - Florida Cancer Specialist - North
RECRUITING

Lecanto, Florida, 34461, United States
Site 0243 - Mark H Zangmeister Cancer Center
RECRUITING

Columbus, Ohio, 43219, United States
Site 0251 - Norton Cancer Institute
RECRUITING

Louisville, Kentucky, 40202, United States
Site 0258 - UC San Diego Moores Cancer Center
ACTIVE_NOT_RECRUITING

La Jolla, California, 92037, United States
Site 0259 - Duke Cancer Center
RECRUITING

Durham, North Carolina, 27710, United States
Site 0263 - Baystate Medical Center
RECRUITING

Springfield, Massachusetts, 01199, United States
Site 0277 - Alliance Cancer Specialist, PC
ACTIVE_NOT_RECRUITING

Wynnewood, Pennsylvania, 19096, United States
Site 0284 - Community Cancer Center North
RECRUITING

Indianapolis, Indiana, 46250, United States
Site 0287 - Ridley Tree Cancer Center
ACTIVE_NOT_RECRUITING

Santa Barbara, California, 93105, United States
Site 0288 - Minnesota Oncology Hematology - Maplewood
RECRUITING

Maplewood, Minnesota, 55109, United States
Site 0295 - Virginia Oncology Associates
RECRUITING

Chesapeake, Virginia, 23320, United States
Site 0307 - Lahey Hospital and Medical Center
RECRUITING

Burlington, Massachusetts, 01805, United States
Site 0308 - Advent Health
RECRUITING

Orlando, Florida, 32803, United States
Site 0316 - Willamette Valley Cancer Institute/Oncology Associates of Oregon
RECRUITING

Eugene, Oregon, 97401, United States
Site 0317 - Nebraska Methodist Hospital
ACTIVE_NOT_RECRUITING

Omaha, Nebraska, 68114, United States
Site 0322 - Inova Schar Cancer Institute
RECRUITING

Fairfax, Virginia, 22031, United States
Site 0323 - Compass Oncology
ACTIVE_NOT_RECRUITING

Vancouver, Washington, 98684, United States
Site 0324 - Illinois Cancer Specialists
ACTIVE_NOT_RECRUITING

Niles, Illinois, 60714, United States
Site 2404 - Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie
RECRUITING

Warsaw, Masovian Voivodeship, 02-781, Poland
Site 2405 - Centrum Badan Klinicznych JCI
RECRUITING

Krakow, Lesser Poland Voivodeship, 30-348, Poland
Site 2414 - Med-Polonia Sp. z o.o.
ACTIVE_NOT_RECRUITING

Poznan, Greater Poland Voivodeship, 60-693, Poland
Site 2419 - Bialostockie Centrum Onkologii im. Marii Sklodowskiej-Curie w Bialymstoku
RECRUITING

Bialystok, Podlaskie Voivodeship, 15-027, Poland
Site 2421 - Szpitale Pomorskie Sp. z o. o.
RECRUITING

Gdynia, Pomeranian Voivodeship, 81-519, Poland
Site 2701 - Sir Charles Gairdner Hospital
RECRUITING

Nedlands, Western Australia, 6009, Australia
Site 2702 - Burnside War Memorial Hospital - The Brian Fricker Oncology Centre
RECRUITING

Toorak Gardens, South Australia, 5065, Australia
Site 2707 - Mater Brisbane
RECRUITING

South Brisbane, Queensland, 4101, Australia
Site 2709 - Cancer Research SA
RECRUITING

Adelaide, South Australia, 5037, Australia
Site 2715 - Icon Cancer Centre - Chermside
RECRUITING

Chermside, Queensland, 4032, Australia
Site 2716 - Epworth Healthcare Freemasons
RECRUITING

East Melbourne, Victoria, 3002, Australia
Site 2717 - St John of God Hospital Subiaco
RECRUITING

Subiaco, Western Australia, 6008, Australia
Site 2904 - Asan Medical Center
RECRUITING

Seoul, 05505, South Korea
Site 2905 - Seoul National University Hospital
RECRUITING

Seoul, 03080, South Korea
Site 2906 - Gangnam Severance Hospital, Yonsei University Health System
RECRUITING

Seoul, 06273, South Korea
Site 2907 - Samsung Medical Center
RECRUITING

Seoul, 06351, South Korea
Site 2908 - National Cancer Center
RECRUITING

Goyang-si, Gyeonggi-do, 10408, South Korea
Site 2909 - Severance Hospital Yonsei University Health System
RECRUITING

Seoul, 03722, South Korea
Site 3101 - AZORG - Aalst
ACTIVE_NOT_RECRUITING

Aalst, Oost-Vlaanderen, 9300, Belgium
Site 3102 - Cliniques Universitaires Saint-Luc
RECRUITING

Brussels, Brussels Capital, 1200, Belgium
Site 3105 - UZ Leuven
RECRUITING

Leuven, Vlaams Brabant, 3000, Belgium
Site 3302 - Istituto Nazionale Tumori IRCCS Fondazione Giovanni Pascale
RECRUITING

Naples, Campania, 80131, Italy
Site 3303 - Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi-Via Massarenti
RECRUITING

Bologna, 40138, Italy
Site 3304 - Fondazione Policlinico Universitario A Gemelli
RECRUITING

Rome, Lazio, 168, Italy
Site 3305 - Istituto Europeo di Oncologia
RECRUITING

Milan, Lombardy, 20141, Italy
Site 3307 - Ospedale San Raffaele S.r.l.
RECRUITING

Milan, Milano, 20132, Italy
Site 3308 - Azienda Ospedaliero Universitaria Di Modena Policlinico
RECRUITING

Modena, Emilia-Romagna, 41124, Italy
Site 3311 - Azienda Ospedaliera Universitaria Integrata Di Verona
RECRUITING

Verona, Veneto, 37126, Italy
Site 3312 - Centro di Riferimento Oncologico
RECRUITING

Aviano, Friuli Venezia Giulia, 33081, Italy
Site 3501 - Hospital Clinico Universitario de Valencia
RECRUITING

Valencia, Valencia, 46010, Spain
Site 3502 - Hospital Universitario La Paz
RECRUITING

Madrid, 28046, Spain
Site 3511 - Instituto de Investigacion Oncologica Vall d'Hebron
RECRUITING

Barcelona, Barcelona, 8035, Spain
Site 3516 - Hospital Universitario Virgen de La Arrixaca
RECRUITING

Murcia, Murcia, 30120, Spain
Site 3517 - Clinica Universidad de Navarra
RECRUITING

Madrid, Madrid, 28027, Spain
Site 3601 - Centre Georges François Leclerc
RECRUITING

Dijon, Côte-d'Or, 21079, France
Site 3602 - Centre Oscar Lambret
RECRUITING

Lille, Nord, 59000, France
Site 3603 - Institut Claudius Regaud
RECRUITING

Toulouse, Haute-Garonne, 31000, France
Site 3604 - Institut Gustave Roussy
RECRUITING

Villejuif, 94800, France
Site 3608 - Hospices Civils de Lyon - Hôpital Lyon Sud
RECRUITING

Pierre-Bénite, Rhône, 69310, France
Site 3611 - ICANS - Institut de cancérologie Strasbourg Europe
ACTIVE_NOT_RECRUITING

Strasbourg, Bas-Rhin, 67200, France
Site 3613 - CHRU Besancon - Hopital Jean Minjoz
RECRUITING

Besançon, Doubs, 25030, France
Site 3614 - Institut de Cancerologie de l'oust
RECRUITING

Saint-Herblain, Pays de la Loire Region, 44800, France
Site 3615 - Hôpital Cochin Port-Royal AP-HP
RECRUITING

Paris, Paris, 75181, France
Site 3616 - Centre Antoine Lacassagne
RECRUITING

Nice, Alpes-Maritimes, 06100, France
Site 3617 - CHU de Brest - Hôpital La Cavale Blanche
RECRUITING

Brest, Finistere, 29200, France
Site 3619 - Centre Léon Bérard
RECRUITING

Lyon, 69373, France
Site 3620 - CHU de Strasbourg - Hopital de Hautepierre
RECRUITING

Strasbourg, 67200, France

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