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Ovarian CancerPhase 1/2NCT05198804

A Study of Azenosertib (ZN-c3) and Niraparib in Subjects With Platinum-Resistant Ovarian Cancer

A Phase 1/2 study testing Azenosertib and Niraparib in people with Ovarian Cancer and Platinum-resistant Ovarian Cancer, run by K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc at 22 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a Phase 1/2 study to evaluate the safety, clinical activity, pharmacokinetics (PK), and pharmacodynamics (PD) of ZN-c3 in combination with niraparib and of ZN-c3 Monotherapy in subjects with platinum-resistant ovarian cancer. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Azenosertib and Niraparib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
117 participants
Where
22 sitesin 2 countries
Study dates
27 Jan 2022to 19 Jan 2026
Phase
Phase 1/2
Are there results?
None posted in the registry

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

  • Histologically or cytologically confirmed recurrent high grade epithelial ovarian, primary peritoneal, or fallopian tube cancer with histologic subtypes of serous, clear cell or endometroid for which there is no known or established treatment available with curative intent.
  • Subjects must have platinum-resistant disease.
  • Must have evaluable or measurable disease according to RECIST v1.1 criterion: defined as at least one lesion that can be accurately measured.
  • Adequate hematologic and organ function.
  • Ability and willingness to take oral medication.
  • Subjects must provide formalin-fixed, paraffin-embedded tumor samples available from the primary or recurrent cancer.

Who cannot join

  • Prior therapy directed at the malignant tumor within the last four weeks prior to Cycle 1 Day 1 (6 weeks for nitrosoureas or mitomycin C).
  • A minimum of 10 days between termination of the prior PARPi and administration of ZN-c3 and niraparib treatment is required.
  • Any investigational drug therapy <28 days.
  • Prior treatment with a WEE1 inhibitor.
  • Known hypersensitivity to any drugs similar to ZN-c3 and/or niraparib in class or its excipients.
  • Participant has any known history or current diagnosis of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).
Show all 12Show fewer
  • Uncontrolled hypertension (Diastolic BP > 90 mmHg or Systolic BP > 140 mmHg).
  • Myocardial impairment of any cause (e.g., cardiomyopathy, ischemic heart disease, significant valvular dysfunction, hypertensive heart disease, and congestive heart failure) resulting in heart failure by New York Heart Association Criteria (Class III or IV).
  • Significant gastrointestinal abnormalities, 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.
  • 12-lead ECG demonstrating a corrected QT interval using Fridericia's formula (QTcF) of >480 ms, except for subjects with atrioventricular pacemakers or other conditions (e.g., right bundle branch block) that render the QT measurement invalid.
  • History or current evidence of congenital or family history of long QT syndrome or Torsades de Pointes (TdP).
  • Taking medications with a known risk of TdP (according to current information provided at https://crediblemeds.org).

Trial locations and contacts

22 sites in 2 countries.

22 sites in 2 countries

United States16 sites

  • Optimum Clinical Research Group- Women's Oncology

    Albuquerque, New Mexico, 87109

  • Rocky Mountain Cancer Centers

    Aurora, Colorado, 80012

  • University of Colorado

    Aurora, Colorado, 80045

  • University of Virginia

    Charlottesville, Virginia, 22908

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Willamette Valley Cancer Institute and Research Center

    Eugene, Oregon, 97401

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031

  • Texas Oncology-Fort Worth Cancer Center

    Fort Worth, Texas, 76104

  • Spectrum Health System

    Grand Rapids, Michigan, 49503

  • Mount Sinai Comprehensive Cancer Center

    Miami Beach, Florida, 33140

  • The Blavatnik Family - Chelsea Medical Center at Mount Sinai

    New York, New York, 10011

  • Rutgers New Jersey Medical School

    Newark, New Jersey, 07103

  • Women and Infants Hospital of Rhode Island

    Providence, Rhode Island, 02905

  • Virginia Commonwealth University

    Richmond, Virginia, 23298

  • MD Anderson Cancer Center, Gynecologic Oncology Center

    Texas City, Texas, 77030

  • Arizona Oncology Associates (Wilmot HOPE) - USOR

    Tucson, Arizona, 85711

Other trials in United States

France6 sites

  • Centre Georges François Leclerc

    Dijon

  • Centre Oscar Lambret

    Lille

  • Centre Hospitalier Lyon Sud

    Saint-Genis-Laval

  • ICANS - Institut de cancérologie Strasbourg Europe

    Strasbourg

  • EDOG - Institut Claudius Regaud

    Toulouse

  • Institut Gustave Roussy

    Villejuif

Other trials in France

About this study

Official title: A Phase 1/2 Dose-Escalation and Dose-Expansion Study of ZN-c3 in Combination With Niraparib and ZN-c3 Monotherapy in Subjects With Platinum-Resistant Ovarian Cancer

This is a Phase 1/2 study to evaluate the safety, clinical activity, pharmacokinetics (PK), and pharmacodynamics (PD) of ZN-c3 in combination with niraparib and of ZN-c3 Monotherapy in subjects with platinum-resistant ovarian cancer.

Read the detailed description

This is a Phase 1/2 open-label, multicenter study to evaluate the safety, clinical activity, PK, and PD of ZN-c3 in combination with niraparib and of ZN-c3 Monotherapy in subjects with platinum-resistant ovarian cancer who have failed Poly (ADP-ribose) polymerase inhibitor (PARPi) maintenance treatment.

Being tested
Azenosertib, Niraparib
Keywords
Wee1, Wee-1
Medical subject headings
Ovarian Neoplasms, Fallopian Tube 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

  • NiraparibDrug

    Niraparib

Study groups in NCT05198804
Study groupRoleWhat they receive
Azenosertib and NiraparibExperimentalAzenosertib in combination with Niraparib
Receives: Drug: Azenosertib; Drug: Niraparib
AzenosertibExperimentalAzenosertib Monotherapy
Receives: Drug: Azenosertib

What is being measured

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

  1. To investigate the safety and tolerability of ZN-c3 in combination with niraparib, including identification of the MTD and RP2D

    Incidence and severity of Dose Limiting Toxicities (DLTs) in DLT-evaluable subjects during Cycle 1

    Measured: 6 months

  2. To determine the safety and tolerability of ZN-c3 monotherapy

    Frequency and severity of AEs and dose modifications

    Measured: 12 months

  3. To investigate the antitumor activity of ZN-c3 monotherapy

    ORR as defined by the revised RECIST Guideline version 1.1 and assessed by ICR.

    Measured: 12 months

Secondary outcomes (10)

  1. To further investigate the antitumor activity of ZN-c3 in combination with niraparib and ZN-c3 monotherapy

    Duration of response (DOR) as key secondary endpoint

    Measured: 30 months

  2. To further investigate the antitumor activity of ZN-c3 in combination with niraparib and ZN-c3 monotherapy

    Clinical Benefit Rate (CBR), Progression Free Survival (PFS) (median and 4-month rate), as defined by the revised RECIST version 1.1

    Measured: 30 months

  3. To further investigate the antitumor activity of ZN-c3 in combination with niraparib and ZN-c3 monotherapy

    Objective Response Rate (ORR) based on investigator assessment

    Measured: 30 months

  4. To investigate the OS of subjects receiving ZN-c3 in combination with niraparib and ZN-c3 monotherapy

    OS (median and at 12 months)

    Measured: 30 months

  5. To investigate the safety and tolerability of ZN-c3 in combination with niraparib and ZN-c3 monotherapy

    Frequency and severity of AEs and dose modifications

    Measured: 30 months

  6. To evaluate changes in Patient Reported Outcomes (PROs) and quality of life

    Ongoing measurement of subject-reported symptomatic toxicity according to the PRO-CTCAE, and determination of change from Baseline in self-reported quality of life using EQ-5D-5L

    Measured: 30 months

  7. To investigate the plasma PK of ZN-c3 and niraparib when given in combination - Maximum Plasma Concentration

    The maximum plasma concentration (Cmax) of ZN-c3 (and its potential metabolites, as applicable) and niraparib (and their potential metabolites, as applicable) will be determined

    Measured: 30 months

  8. To investigate the plasma PK of ZN-c3 and niraparib when given in combination - Area under the plasma concentration-time curve from 0 to 24h

    Area under the plasma concentration-time curve from 0 to 24h [AUC0-24h] of ZN-c3 (and its potential metabolites, as applicable) and niraparib (and their potential metabolites, as applicable) will be determined

    Measured: 30 months

  9. To investigate the plasma PK of ZN-c3 and niraparib when given in combination - Trough concentration

    Trough concentration [Ctrough] of ZN-c3 (and its potential metabolites, as applicable) and niraparib (and their potential metabolites, as applicable) will be determined

    Measured: 30 months

  10. To investigate the plasma PK of ZN-c3 and niraparib when given in combination - Time to maximum plasma concentration

    Time to maximum plasma concentration (Tmax) of ZN-c3 (and its potential metabolites, as applicable) and niraparib (and their potential metabolites, as applicable) will be determined

    Measured: 30 months

Timeline

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

  1. First posted20 Jan 2022
  2. Study start27 Jan 2022
  3. Primary completion15 Oct 2025
  4. Study completion19 Jan 2026

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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
117 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05198804
Sponsor's protocol ID
ZN-c3-006
Other IDs
2021-004161-13, GOG-3067, 2024-515196-35-00
Status last verified
Mar 2026
First submitted
8 Dec 2021
Last updated
18 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Azenosertib and Niraparib in people with Ovarian Cancer and Platinum-resistant Ovarian Cancer, run by K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc at 22 sites in 2 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 6 inclusion and 12 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: finished, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in United States, France. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To investigate the safety and tolerability of ZN-c3 in combination with niraparib, including identification of the MTD and RP2D (time frame: 6 months). The study lists 3 primary outcomes in all. 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 NCT05198804.

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 18 Mar 2026.

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