A Phase 1/2 interventional study of Azenosertib and Niraparib in Ovarian Cancer, Platinum-resistant Ovarian Cancer and Primary Peritoneal Carcinoma, sponsored by K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc. Completed at 22 sites in 2 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-18.
Sponsored by K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc · Phase 1/2, Interventional, and Treatment
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.
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.
Key Inclusion Criteria:
Key Exclusion Criteria:
Azenosertib in combination with Niraparib
Drug: Azenosertib · Drug: Niraparib
Azenosertib Monotherapy
Drug: Azenosertib
Azenosertib
Also known as: ZN-c3
Niraparib
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
Time frame: 6 months
To determine the safety and tolerability of ZN-c3 monotherapy
Frequency and severity of AEs and dose modifications
Time frame: 12 months
To investigate the antitumor activity of ZN-c3 monotherapy
ORR as defined by the revised RECIST Guideline version 1.1 and assessed by ICR.
Time frame: 12 months
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
Time frame: 30 months
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
Time frame: 30 months
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
Time frame: 30 months
To investigate the OS of subjects receiving ZN-c3 in combination with niraparib and ZN-c3 monotherapy
OS (median and at 12 months)
Time frame: 30 months
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
Time frame: 30 months
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
Time frame: 30 months
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
Time frame: 30 months
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
Time frame: 30 months
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
Time frame: 30 months
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
Time frame: 30 months
To investigate the PD and downstream effects of ZN-c3 when given in combination with niraparib - Baseline Cyclin E expression
Baseline Cyclin E expression in pre-dose tumor tissue
Time frame: 30 months
To investigate the PD and downstream effects of ZN-c3 when given in combination with niraparib - Molecular determinants of sensitivity to ZN-c3
Molecular determinants of sensitivity to ZN-c3 including but not limited to Baseline DNA Damage Repair (DDR) gene mutations, deletions, copy number variations or indices of genetic instability in either tumor tissue or cell-free DNA (cfDNA)
Time frame: 30 months
To investigate the PD and downstream effects of ZN-c3 when given in combination with niraparib - Changes in genomic or protein biomarkers
Changes in genomic or protein biomarkers in peripheral blood samples
Time frame: 30 months
Plan to share: No
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K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc