A Phase 2 interventional study of azenosertib in High-Grade Serous Ovarian, Fallopian Tube or Primary Peritoneal Cancer, sponsored by K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc. Recruiting at 86 sites in 8 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc · Phase 2, Interventional, and Treatment
This is a multi-part Phase 2 study to evaluate the efficacy and safety of azenosertib (ZN-c3) in subjects with Platinum-Resistant, High-Grade Serous Ovarian, Fallopian Tube, or Primary Peritoneal Cancer. Part 2 of the study will be conducted in subjects whose tumors are Cyclin E1 positive as determined by central review using the Sponsor's investigational clinical trial assay.
A Phase 2 study to evaluate the efficacy and safety of azenosertib (ZN-c3) 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. By inhibiting WEE1, azenosertib enables cell cycle progression, despite high levels of DNA damage, thereby resulting in the accumulation of DNA damage leading to mitotic catastrophe and cancer cell death.
The study consists of two parts:
Part 1: All comers, no biomarker status required (completed enrollment)
Part 2: Cyclin E1 positive protein expression required
Prior therapy:
Exclusion Criteria:
Any of the following treatment interventions within the specified time frame prior to C1D1:
A serious illness or medical condition(s) including, but not limited to:
Azenosertib 400mg administered once daily on a 5 days on, 2 days off intermittent schedule.
Drug: azenosertib
Azenosertib 400mg administered once daily on a 5 days on, 2 days off intermittent schedule
Drug: azenosertib
Azenosertib 300mg administered once daily on a 5 days on, 2 days off intermittent schedule
Drug: azenosertib
Azenosertib 400mg administered once daily on a 5 days on, 2 days off intermittent schedule
Drug: azenosertib
Azenosertib 400mg administered once daily on a 5 days on, 2 days off intermittent schedule
Drug: azenosertib
Azenosertib (ZN-c3) will be administered orally.
Also known as: ZN-c3
Objective Response Rate (ORR) defined by RECIST v1.1 [Part 2]
Participants who achieve partial response (PR) or complete response (CR) per RECIST v1.1 criteria.
Time frame: Up to approximately 12 months from the enrollment of the last subject
Duration of response (DOR) defined by RECIST v1.1 [Part 2]
Time from the date of first documented response (CR or PR that is subsequently confirmed per RECIST v1.1) until the date of progressive disease (PD) or death.
Time frame: Up to approximately 12 months from the enrollment of the last subject
Progression free survival (PFS) defined by RECIST v1.1 [Part 2]
Time from the date of first dose until the date of PD or death.
Time frame: Up to approximately 12 months from the enrollment of the last subject
Clinical Benefit Rate (CBR) defined by RECIST v1.1 [Part 2]
The percentage of participants who have at least 1 confirmed response of CR or PR, or stable disease for at least 16 weeks before any evidence of progression.
Time frame: Up to approximately 12 months from the enrollment of the last subject
CA-125 response by GCIG criteria [Part 2]
The GCIG CA-125 response was defined as at least 50% reduction in CA-125 levels from baseline.
Time frame: Up to approximately 12 months from the enrollment of the last subject
Number of Subjects experiencing treatment emergent adverse events (TEAEs) [Part 2]
Time frame: Up to approximately 12 months from the enrollment of the last subject
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K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc