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Ovarian CancerPhase 3ASPENOVANCT07546500

A Study of Azenosertib (ZN-c3) Versus Investigator's Choice Chemotherapy in Subjects With Platinum-Resistant High-Grade Serous Ovarian, Primary Peritoneal, or Fallopian Tube Cancers Positive for Cyclin E1 Protein Expression

A Phase 3 study testing Investigator's choice of Chemotherapy and Azenosertib in people with Ovarian Cancer, run by K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc at 59 sites in 12 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 randomized, Phase 3 trial designed to evaluate the efficacy and safety of azenosertib compared to Investigator's choice of chemotherapy in subjects with platinum-resistant ovarian cancer whose tumors are positive for cyclin E1 protein expression. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Ovarian Cancer
What is being tested?
Investigator's choice of Chemotherapy and Azenosertib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
420 participants
Where
59 sitesin 12 countries
Study dates
17 Apr 2026to 30 Apr 2030
Phase
Phase 3
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

  • Female age ≥ 18 years
  • High-grade serous epithelial ovarian, primary peritoneal, or fallopian tube cancer
  • Measurable disease per RECIST Version 1.1
  • Eastern Cooperative Oncology Group (ECOG) performance status score 0-1
  • 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
  • Prior Therapy:
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  • Subject must have platinum-resistant disease
  • One to 3 prior lines or regimens are allowed (1 to 4 prior lines are permitted, if prior mirvetuximab)
  • 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
  • Adequate hematologic and organ function during the screening period

Who cannot join

  • 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.
  • Subjects with primary platinum-refractory disease.
  • Prior therapy with azenosertib or any other WEE1 inhibitor, ATR inhibitor, CHK1/2 inhibitor, or (PKMYT1) inhibitor for PROC.
  • A serious illness or medical condition(s) including, but not limited to, the following:
  • Clinically or radiographically unstable brain metastases or leptomeningeal disease that requires immediate treatment. Subjects with asymptomatic brain metastases are eligible.
  • Acute kidney injury requiring intervention, or presence of indwelling urinary catheter or percutaneous nephrostomy.
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  • 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.
  • 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.
  • 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
  • Myocardial impairment of any cause resulting in heart failure by New York Heart Association criteria (Class II, III or IV).
  • 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
  • Any of the following treatment interventions within the specified time frame before randomization:
  • Hospitalization within 14 days
  • Major surgery within 28 days
  • Any chemotherapy or targeted tumor therapy within 21 days or 5 half-lives (whichever is shorter)
  • 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 with prescription or nonprescription drugs that are prohibited per protocol.
  • Inability to discontinue consumption of food and herbal supplements that are prohibited per protocol
  • Prior wide-field radiotherapy affecting ≥ 20% of the bone marrow.
  • Unresolved toxicity of Grade > 1 attributed to any prior therapies (excluding Grade ≤ 2 neuropathy, alopecia, or skin pigmentation).
  • Subjects who are 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

Trial locations and contacts

59 sites in 12 countries. Contact the study team or a site near you to ask about taking part.

Project Director contact

858.263.4333

medicalaffairs@zentalis.com

59 sites in 12 countries

United States12 sites, 12 recruiting

  • Site 0110

    Antioch, California, 94531

    Not yet recruiting

  • Site 0104

    Beverly Hills, California, 90212

    Recruiting

  • Site 0111

    Camden, New Jersey, 08103

    Not yet recruiting

  • Site 0108

    Columbus, Ohio, 43026

    Not yet recruiting

  • Site 0109

    Philadelphia, Pennsylvania, 19104

    Not yet recruiting

  • Site 0113

    Philadelphia, Pennsylvania, 19111

    Not yet recruiting

  • Site 0107

    Phoenix, Arizona, 85016

    Not yet recruiting

  • Site 0105

    Portland, Oregon, 97210

    Not yet recruiting

  • Site 0115

    San Francisco, California, 94109

    Not yet recruiting

  • Site 0112

    Sioux Falls, South Dakota, 57105

    Not yet recruiting

  • Site 0101

    Torrance, California, 90505

    Recruiting

  • Site 0114

    Willow Grove, Pennsylvania, 19090

    Not yet recruiting

Other trials in United States

France9 sites, 9 recruiting

  • Site 3508

    Besançon, 25000

    Not yet recruiting

  • Site 3502

    Brest, 29609

    Not yet recruiting

  • Site 3507

    Dijon, 21079

    Not yet recruiting

  • Site 3504

    Lyon, 69373

    Not yet recruiting

  • Site 3503

    Paris, 75014

    Not yet recruiting

  • Site 3501

    Pierre-Bénite, 69495

    Not yet recruiting

  • Site 3509

    Saint-Herblain, 44805

    Not yet recruiting

  • Site 3505

    Strasbourg, 67098

    Not yet recruiting

  • Site 3506

    Villejuif, 94805

    Not yet recruiting

Other trials in France

Italy7 sites, 7 recruiting

  • Site 3801

    Bologna, 40138

    Not yet recruiting

  • Site 3805

    Milan, 20132

    Not yet recruiting

  • Site 3804

    Milan, 20141

    Not yet recruiting

  • Site 3803

    Milan, 20159

    Not yet recruiting

  • Site 3802

    Naples, 80131

    Not yet recruiting

  • Site 3807

    Prato, 59100

    Not yet recruiting

  • Site 3806

    Rome, 00168

    Not yet recruiting

Other trials in Italy

South Korea6 sites, 6 recruiting

  • Site 1203

    Daegu, 42601

    Recruiting

  • Site 1206

    Goyang-si, 10408

    Not yet recruiting

  • Site 1202

    Seoul, 03080

    Recruiting

  • Site 1205

    Seoul, 03722

    Recruiting

  • Site 1204

    Seoul, 06273

    Not yet recruiting

  • Site 1201

    Seoul, 06351

    Recruiting

Other trials in South Korea

Spain6 sites, 6 recruiting

  • Site 4201

    Barcelona, 08028

    Not yet recruiting

  • Site 4205

    Barcelona, 08041

    Not yet recruiting

  • Site 4202

    Madrid, 28034

    Not yet recruiting

  • Site 4206

    Madrid, 28040

    Not yet recruiting

  • Site 4203

    Málaga, 29011

    Not yet recruiting

  • Site 4204

    Vigo, 36212

    Not yet recruiting

Other trials in Spain

Canada4 sites, 4 recruiting

  • Site 0204

    Montreal, Quebec, H1T 2M4

    Not yet recruiting

  • Site 0203

    Montreal, Quebec, H2X 0C1

    Not yet recruiting

  • Site 0202

    Sherbrooke, Quebec, J1H 5N4

    Not yet recruiting

  • Site 0201

    Toronto, Ontario, M5G 2M9

    Not yet recruiting

Other trials in Canada

Poland4 sites, 4 recruiting

  • Site 4006

    Krakow, 30-348

    Not yet recruiting

  • Site 4001

    Lodz, 93-338

    Not yet recruiting

  • Site 4004

    Poznan, 61-848

    Not yet recruiting

  • Site 4003

    Szczecin, 70-111

    Not yet recruiting

Other trials in Poland

Australia3 sites, 3 recruiting

  • Site 1102

    Adelaide, South Australia, 5000

    Recruiting

  • Site 1103

    Nedlands, 6009

    Not yet recruiting

  • Site 1101

    Randwick, New South Wales, 2031

    Not yet recruiting

Other trials in Australia

Belgium2 sites, 2 recruiting

  • Site 3002

    Brussels, 1020

    Not yet recruiting

  • Site 3001

    Leuven, 3000

    Not yet recruiting

Other trials in Belgium

Germany2 sites, 2 recruiting

  • Site 3602

    Berlin, D-13353

    Not yet recruiting

  • Site 3601

    Dresden, 01307

    Not yet recruiting

Other trials in Germany

Ireland2 sites, 2 recruiting

  • Site 3703

    Cork, T12 DC4A

    Not yet recruiting

  • Site 3702

    Dublin, D08 NYH1

    Not yet recruiting

Other trials in Ireland

Taiwan2 sites, 2 recruiting

  • Site 1301

    Taichung, 40705

    Not yet recruiting

  • Site 1302

    Taipei, 11217

    Not yet recruiting

Other trials in Taiwan

About this study

Official title: A Randomized, Open-Label Phase 3 Study of Azenosertib Versus Investigator's Choice of Chemotherapy in Platinum-Resistant High-Grade Serous Ovarian, Primary Peritoneal, or Fallopian Tube Cancers Positive for Cyclin E1 Protein Expression

This is a randomized, Phase 3 trial designed to evaluate the efficacy and safety of azenosertib compared to Investigator's choice of chemotherapy in subjects with platinum-resistant ovarian cancer whose tumors are positive for cyclin E1 protein expression.

Read the detailed description

A Phase 3 study to evaluate the efficacy, safety, and overall clinical benefit of azenosertib (ZN-c3) compared with Investigator's choice of chemotherapy 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. In HGSOC, high Cyclin E1 protein drives replication stress and increases tumor reliance on WEE1-mediated G2/M checkpoint control. Treating tumor cells with azenosertib promotes premature cell cycle progression leading to increased replication stress and accumulation of DNA damage pushing cells to mitotic catastrophe resulting in tumor cell death.

Conditions
Ovarian Cancer
Being tested
Investigator's choice of Chemotherapy, Azenosertib
Keywords
Platinum-Resistant Ovarian Cancer (PROC), OvCa
Medical subject headings
Ovarian Neoplasms

What participants receive

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

  • Investigator's choice of ChemotherapyDrug

    The investigator will select the chemotherapy in accordance with the protocol defined requirements. The possible choices as defined by the protocol:

    • Paclitaxel
    • Gemcitabine
    • Pegylated liposomal doxorubicin (PLD)
    • Topotecan

    The selected chemotherapy will be administered intravenously

  • AzenosertibDrug

    Also called ZN-c3

    Azenosertib 400 mg will be administered orally.

Study groups in NCT07546500
Study groupRoleWhat they receive
Arm A Azenosertib 400 mg administered daily on a 5 days on, 2 days off intermittent scheduleExperimentalNot described
Receives: Drug: Azenosertib
Experimental: Arm C Investigator's choice of chemotherapy at the dose defined by the protocolActive comparatorNot described
Receives: Drug: Investigator's choice of Chemotherapy

What is being measured

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

  1. Progression free survival (PFS) per RECIST v1.1 as assessed by Investigator

    Time from randomization to the first documented tumor progression (per RECIST v1.1) or death from any cause, whichever occurs first.

    Measured: Up to approximately 24 months from the enrollment of the last subject

Secondary outcomes (7)

  1. Overall survival

    Time from randomization until death due to any cause

    Measured: Up to approximately 24 months from the enrollment of the last subject

  2. PFS per RECIST 1.1 as assessed by blinded independent central review (ICR)

    Time from randomization to the first documented tumor progression (per RECIST v1.1) or death from any cause, whichever occurs first.

    Measured: Up to approximately 24 months from the enrollment of the last subject

  3. Objective Response Rate (ORR) per RECIST v1.1 and assessed by Investigator

    Proportion of patients who attain a partial response (PR) or complete response (CR) per RECIST v1.1

    Measured: Up to approximately 24 months from the enrollment of the last subject

  4. Change from baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire score (EORTC QLQ)-Core 30 (C30) at each post baseline visit

    Assess changes over time in cancer-specific and patient-reported outcome instruments assessing global health status/quality of life, functional domains, and symptom burden.

    Measured: Up to approximately 24 months from the enrollment of the last subject

  5. Change from baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire score (EORTC QLQ)-OV28 at each post baseline visit

    Assess changes over time in cancer-specific and patient-reported outcome instruments assessing global health status/quality of life, functional domains, and symptom burden.

    Measured: Up to approximately 24 months from the enrollment of the last subject

  6. Change from baseline in EQ-5D-5L score at each post baseline visit

    Assess changes over time in cancer-specific and patient-reported outcome instruments assessing global health status/quality of life, functional domains, and symptom burden.

    Measured: Up to approximately 24 months from the enrollment of the last subject

  7. Number of Subjects experiencing treatment emergent adverse events (TEAEs)

    Assess adverse events occurring for the first time or worsening of a pre-existing event during the treatment period until 30 days after the last dose of study drug

    Measured: Up to approximately 24 months and 30 days 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 Apr 2026
  2. Study start17 Apr 2026
  3. Primary completion31 May 2028 (estimated)
  4. Study completion30 Apr 2030 (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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
420 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07546500
Sponsor's protocol ID
ZN-c3-020
Other IDs
GOG-3147, ENGOT-ov109
Acronym
ASPENOVA
Status last verified
Aug 2026
First submitted
26 Mar 2026
Last updated
12 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Investigator's choice of Chemotherapy and Azenosertib in people with Ovarian Cancer, run by K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc at 59 sites in 12 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 25 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 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 59 sites in United States, France, Italy, South Korea, Spain and 7 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Progression free survival (PFS) per RECIST v1.1 as assessed by Investigator (time frame: Up to approximately 24 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 NCT07546500.

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 12 Aug 2026; AzTrials last refreshed its copy on 7 Nov 2026.

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