Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New drug azenosertib takes on Chemo-Resistant ovarian cancer in phase 3 trial

NCT ID NCT07546500

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 13, 2026 · Updated 5 times

Summary

This phase 3 study tests whether a new drug called azenosertib works better than standard chemotherapy for people with a specific type of ovarian cancer that no longer responds to platinum-based treatments. The trial enrolls 420 women whose tumors have a high level of a protein called cyclin E1. The main goal is to see how long the cancer stays under control with azenosertib compared to chemotherapy.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

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

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 420 people

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

Started

Apr 2026

Expected to finish

Apr 2030

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. Female age ≥ 18 years 2. High-grade serous epithelial ovarian, primary peritoneal, or fallopian tube cancer 3. Measurable disease per RECIST Version 1.1 4. Eastern Cooperative Oncology Group (ECOG) performance status score 0-1 5. The subject's tumor tissue must be positive for cyclin E1 protein expression per the Sponsor's clinically validated cyclin E1 IHC investigational, in vitro diagnostic assay 6. Prior Therapy: 1. Subject must have platinum-resistant disease 2. One to 3 prior lines or regimens are allowed (1 to 4 prior lines are permitted, if prior mirvetuximab) 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 7. Adequate hematologic and organ function during the screening period Exclusion Criteria: 1. 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, nonmelanoma skin carcinoma, Stage 1 uterine cancer, or other malignancies with an expected curative outcome. 2. Subjects with primary platinum-refractory disease. 3. Prior therapy with azenosertib or any other WEE1 inhibitor, ATR inhibitor, CHK1/2 inhibitor, or (PKMYT1) inhibitor for PROC. 4. A serious illness or medical condition(s) including, but not limited to, the following: 1. Clinically or radiographically unstable brain metastases or leptomeningeal disease that requires immediate treatment. Subjects with asymptomatic brain metastases are eligible. 2. Acute kidney injury requiring intervention, or presence of indwelling urinary catheter or percutaneous nephrostomy. 3. Significant gastrointestinal abnormalities, including an inability to take oral medication, requirement for IV 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. 4. Any evidence of small bowel obstruction as determined by air/fluid levels on computed tomography (CT) scan, recent hospitalization for small bowel obstruction within 3 months before randomization, or recurrent paracentesis or thoracentesis within 6 weeks before randomization. 5. 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 randomization 6. Myocardial impairment of any cause resulting in heart failure by New York Heart Association criteria (Class II, III or IV). 7. Medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results 5. Any of the following treatment interventions within the specified time frame before randomization: 1. Hospitalization within 14 days 2. Major surgery within 28 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) 6. Inability to discontinue treatment with prescription or nonprescription drugs that are prohibited per protocol. 7. Inability to discontinue consumption of food and herbal supplements that are prohibited per protocol 8. Prior wide-field radiotherapy affecting ≥ 20% of the bone marrow. 9. Unresolved toxicity of Grade \> 1 attributed to any prior therapies (excluding Grade ≤ 2 neuropathy, alopecia, or skin pigmentation). 10. Subjects who are immunocompromised or HIV-positive on highly active anti-retroviral therapy 11. Subjects with known active hepatitis B or hepatitis C infection 12. Individuals who are judged by the Investigator to be unsuitable as study subjects

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Ovarian cancer are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

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

As listed by the trial registrant

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

Ovarian cancer

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    59 sites in 12 countries. The list below names each one and where it is.

  3. 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 ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Site 0101

    RECRUITING

    Torrance, California, 90505, United States

  • Site 0104

    RECRUITING

    Beverly Hills, California, 90212, United States

  • Site 0105

    NOT_YET_RECRUITING

    Portland, Oregon, 97210, United States

  • Site 0107

    NOT_YET_RECRUITING

    Phoenix, Arizona, 85016, United States

  • Site 0108

    NOT_YET_RECRUITING

    Columbus, Ohio, 43026, United States

  • Site 0109

    NOT_YET_RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Site 0110

    NOT_YET_RECRUITING

    Antioch, California, 94531, United States

  • Site 0111

    NOT_YET_RECRUITING

    Camden, New Jersey, 08103, United States

  • Site 0112

    NOT_YET_RECRUITING

    Sioux Falls, South Dakota, 57105, United States

  • Site 0113

    NOT_YET_RECRUITING

    Philadelphia, Pennsylvania, 19111, United States

  • Site 0114

    NOT_YET_RECRUITING

    Willow Grove, Pennsylvania, 19090, United States

  • Site 0115

    NOT_YET_RECRUITING

    San Francisco, California, 94109, United States

  • Site 0201

    NOT_YET_RECRUITING

    Toronto, Ontario, M5G 2M9, Canada

  • Site 0202

    NOT_YET_RECRUITING

    Sherbrooke, Quebec, J1H 5N4, Canada

  • Site 0203

    NOT_YET_RECRUITING

    Montreal, Quebec, H2X 0C1, Canada

  • Site 0204

    NOT_YET_RECRUITING

    Montreal, Quebec, H1T 2M4, Canada

  • Site 1101

    NOT_YET_RECRUITING

    Randwick, New South Wales, 2031, Australia

  • Site 1102

    RECRUITING

    Adelaide, South Australia, 5000, Australia

  • Site 1103

    NOT_YET_RECRUITING

    Nedlands, 6009, Australia

  • Site 1201

    RECRUITING

    Seoul, 06351, South Korea

  • Site 1202

    RECRUITING

    Seoul, 03080, South Korea

  • Site 1203

    RECRUITING

    Daegu, 42601, South Korea

  • Site 1204

    NOT_YET_RECRUITING

    Seoul, 06273, South Korea

  • Site 1205

    RECRUITING

    Seoul, 03722, South Korea

  • Site 1206

    NOT_YET_RECRUITING

    Goyang-si, 10408, South Korea

  • Site 1301

    NOT_YET_RECRUITING

    Taichung, 40705, Taiwan

  • Site 1302

    NOT_YET_RECRUITING

    Taipei, 11217, Taiwan

  • Site 3001

    NOT_YET_RECRUITING

    Leuven, 3000, Belgium

  • Site 3002

    NOT_YET_RECRUITING

    Brussels, 1020, Belgium

  • Site 3501

    NOT_YET_RECRUITING

    Pierre-Bénite, 69495, France

  • Site 3502

    NOT_YET_RECRUITING

    Brest, 29609, France

  • Site 3503

    NOT_YET_RECRUITING

    Paris, 75014, France

  • Site 3504

    NOT_YET_RECRUITING

    Lyon, 69373, France

  • Site 3505

    NOT_YET_RECRUITING

    Strasbourg, 67098, France

  • Site 3506

    NOT_YET_RECRUITING

    Villejuif, 94805, France

  • Site 3507

    NOT_YET_RECRUITING

    Dijon, 21079, France

  • Site 3508

    NOT_YET_RECRUITING

    Besançon, 25000, France

  • Site 3509

    NOT_YET_RECRUITING

    Saint-Herblain, 44805, France

  • Site 3601

    NOT_YET_RECRUITING

    Dresden, 01307, Germany

  • Site 3602

    NOT_YET_RECRUITING

    Berlin, D-13353, Germany

  • Site 3702

    NOT_YET_RECRUITING

    Dublin, D08 NYH1, Ireland

  • Site 3703

    NOT_YET_RECRUITING

    Cork, T12 DC4A, Ireland

  • Site 3801

    NOT_YET_RECRUITING

    Bologna, 40138, Italy

  • Site 3802

    NOT_YET_RECRUITING

    Naples, 80131, Italy

  • Site 3803

    NOT_YET_RECRUITING

    Milan, 20159, Italy

  • Site 3804

    NOT_YET_RECRUITING

    Milan, 20141, Italy

  • Site 3805

    NOT_YET_RECRUITING

    Milan, 20132, Italy

  • Site 3806

    NOT_YET_RECRUITING

    Rome, 00168, Italy

  • Site 3807

    NOT_YET_RECRUITING

    Prato, 59100, Italy

  • Site 4001

    NOT_YET_RECRUITING

    Lodz, 93-338, Poland

  • Site 4003

    NOT_YET_RECRUITING

    Szczecin, 70-111, Poland

  • Site 4004

    NOT_YET_RECRUITING

    Poznan, 61-848, Poland

  • Site 4006

    NOT_YET_RECRUITING

    Krakow, 30-348, Poland

  • Site 4201

    NOT_YET_RECRUITING

    Barcelona, 08028, Spain

  • Site 4202

    NOT_YET_RECRUITING

    Madrid, 28034, Spain

  • Site 4203

    NOT_YET_RECRUITING

    Málaga, 29011, Spain

  • Site 4204

    NOT_YET_RECRUITING

    Vigo, 36212, Spain

  • Site 4205

    NOT_YET_RECRUITING

    Barcelona, 08041, Spain

  • Site 4206

    NOT_YET_RECRUITING

    Madrid, 28040, Spain

More trials for these conditions

Other studies related to the condition(s) this trial covers.