> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-azenosertib-zn-c3-in-subjects-with-platinum-35a0b920-5423-4580-8bb9-86ecfa32b8d4 > Record changed: 2026-10-13 # A Study of Azenosertib (ZN-c3) in Subjects With Platinum-Resistant High-Grade Serous Ovarian, Fallopian Tube or Primary Peritoneal Cancer NCT05128825 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05128825) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05128825) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05128825) Participants 310 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05128825) Lead sponsor K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05128825) Start date 2022-02-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05128825) Number of sites 92 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05128825) ## Title and summary **Summary** 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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05128825) **Acronym** DENALI Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05128825) **Short title** A Study of Azenosertib (ZN-c3) in Subjects With Platinum-Resistant High-Grade Serous Ovarian, Fallopian Tube or Primary Peritoneal Cancer Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05128825) **Official title** A Phase 2 Open-Label, Multicenter Study To Evaluate Efficacy And Safety Of ZN-c3 In Subjects With High-Grade Serous Ovarian, Fallopian Tube, Or Primary Peritoneal Cancer (DENALI / ZN-c3-005 / GOG-3066) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05128825) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05128825) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05128825) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05128825) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05128825) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05128825) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05128825) ## Dates **Completion date** 2027-06-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05128825) **First posted** 2021-11-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05128825) **Registry last updated** 2026-07-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05128825) **Primary completion date** 2026-12-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05128825) **Start date** 2022-02-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05128825) ## Size and sites **Participants** 310 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05128825) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05128825) **Planned participants** 310 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05128825) **Protocol amendments** 11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05128825) **Number of sites** 92 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05128825) ## Sponsor and oversight **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05128825) **Lead sponsor** K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05128825) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05128825) ## Identifiers **Registry ID** NCT05128825 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05128825) **ClinicalTrials.gov ID** NCT05128825 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05128825) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05128825) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05128825) ## Outcomes ### Primary outcomes 1. Objective Response Rate (ORR) defined by RECIST v1.1 \[Part 2\] Timeframe: Up to approximately 12 months from the enrollment of the last subject Participants who achieve partial response (PR) or complete response (CR) per RECIST v1.1 criteria. ### Secondary outcomes 1. Duration of response (DOR) defined by RECIST v1.1 \[Part 2\] Timeframe: Up to approximately 12 months from the enrollment of the last subject 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. 2. Progression free survival (PFS) defined by RECIST v1.1 \[Part 2\] Timeframe: Up to approximately 12 months from the enrollment of the last subject Time from the date of first dose until the date of PD or death. 3. Clinical Benefit Rate (CBR) defined by RECIST v1.1 \[Part 2\] Timeframe: Up to approximately 12 months from the enrollment of the last subject 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. 4. CA-125 response by GCIG criteria \[Part 2\] Timeframe: Up to approximately 12 months from the enrollment of the last subject The GCIG CA-125 response was defined as at least 50% reduction in CA-125 levels from baseline. 5. Number of Subjects experiencing treatment emergent adverse events (TEAEs) \[Part 2\] Timeframe: Up to approximately 12 months from the enrollment of the last subject Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05128825) ## Eligibility **Sex** Female **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria 1. Age ≥18 years 2. High-grade serous ovarian, fallopian tube or primary peritoneal cancer 3. Tumor testing (archival acceptable) confirms a positive Cyclin E1 protein status result determined by IHC using the Sponsor's investigational clinical trial assay 4. Prior therapy: 1. Subjects must have platinum-resistant disease 2. Parts 2a and 2b: One to 3 prior lines or regimens are allowed (1 to 4 prior lines are permitted, if prior mirvetuximab) 3. Part 2c: Subjects with PROC may have 1 to 4 prior lines or regimens. Prior treatment in this cohort includes a weekly taxane regimen, either as single agent or in combination, per protocol 4. Prior bevacizumab treatment is required, if eligible per standard of care 5. Prior PARP inhibitor treatment is required if BRCA 1/2 mutation or HRD, if eligible per standard of care 6. Prior mirvetuximab treatment is required, if eligible per standard of care 5. Measurable disease per RECIST Version 1.1. 6. Adequate hematologic and organ function, as defined in protocol 7. ECOG 0-1 ### Exclusion criteria 1. Primary platinum-refractory disease 2. Subjects with endometrioid, clear cell, mucinous, or sarcomatous histology, mixed tumors containing any of the above histologies, low-grade, borderline, or other ovarian tumors 3. Any of the following treatment interventions within the specified time frame prior to C1D1: 1. Major surgery within 28 days 2. Hospitalization within 14 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). 7. Inability to discontinue treatment prescription or non-prescription drugs, or to discontinue consumption of food and herbal supplements that are strong or moderate CYP3A inhibitors and inducers or P-gp inhibitors at least 14 days prior to C1D1. 4. Prior therapy with ZN-c3 or any other WEE1 inhibitor, ATR inhibitor, PKMYT1 inhibitor, or CHK1/2 inhibitor. 5. A serious illness or medical condition(s) including, but not limited to: 1. Clinically or radiographically unstable brain metastases or leptomeningeal disease that requires immediate treatment. Subjects with asymptomatic brain metastases are eligible. 2. Myocardial impairment resulting in heart failure (NYHA Class II-IV) 3. Severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase risk associated with study participation or may interfere with interpretation of study results 4. Acute kidney injury requiring intervention or intravenous fluid in the last 14 days or presence of indwelling urinary catheter or percutaneous nephrostomy. 5. Significant gastrointestinal abnormalities, including an inability to take oral medication, requirement for intravenous 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. 6. 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 C1D1 7. Any evidence of bowel obstruction as determined by air/fluid levels on computed tomography (CT scan, recent hospitalization for small bowel obstruction within 3 months prior to C1D1, or recurrent paracentesis or thoracentesis within 6 weeks prior to C1D1. 6. Unresolved toxicity of Grade >1 attributed to any prior therapies (excluding Grade ≤2 neuropathy, alopecia, or skin pigmentation). 7. Pregnant or lactating female subject or female subject of childbearing potential who has a positive serum pregnancy test within 14 days prior to C1D1. 8. 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, non-melanoma skin carcinoma, Stage 1 uterine cancer, or other malignancies with an expected curative outcome. 9. Subjects who are known to be immunocompromised or HIV-positive on highly active anti-retroviral therapy. 10. Subjects with known active hepatitis B or hepatitis C infection. 11. Individuals who are judged by the Investigator to be unsuitable as study subjects. 12. Subjects who had prior wide-field radiotherapy affecting ≥ 20% of the bone marrow. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05128825) ## Sites - Site 0170-USA Mitchell Cancer InstituteMobile, United StatesRecruiting - Site 0143 - HonorHealthPhoenix, United StatesRecruiting - Site 0102 - University of Arizona Cancer CenterTucson, United StatesRecruiting - Site 0258 - UC San Diego Moores Cancer CenterLa Jolla, United StatesActive, not recruiting - Site 0287 - Ridley Tree Cancer CenterSanta Barbara, United StatesActive, not recruiting - Site 0135 - Rocky Mountain Cancer CentersLone Tree, United StatesRecruiting - Site 0158 - Hartford HealthCareHartford, United StatesRecruiting - Site 0239 - Florida Cancer Specialists - EastDaytona Beach, United StatesRecruiting - Site 0241 - Florida Cancer Specialist - NorthLecanto, United StatesRecruiting - Site 0173 - Mount Sinai Medical CenterMiami Beach, United StatesRecruiting - Site 0308 - Advent HealthOrlando, United StatesRecruiting - Site 0108 - Emory University HospitalAtlanta, United StatesRecruiting - Site 0236 - Memorial HealthSavannah, United StatesActive, not recruiting - Site 0324 - Illinois Cancer SpecialistsNiles, United StatesActive, not recruiting - Site 0284 - Community Cancer Center NorthIndianapolis, United StatesRecruiting - Site 0217 - St Vincent Hospital and Health Care CentersIndianapolis, United StatesRecruiting - Site 0251 - Norton Cancer InstituteLouisville, United StatesRecruiting - Site 0146 - Maryland Oncology Hematology, PARockville, United StatesActive, not recruiting - Site 0221 - Tufts Medical Center - PPDSBoston, United StatesRecruiting - Site 0104 - Dana Farber Cancer InstituteBoston, United StatesRecruiting - Site 0307 - Lahey Hospital and Medical CenterBurlington, United StatesRecruiting - Site 0263 - Baystate Medical CenterSpringfield, United StatesRecruiting - Site 0101 - Barbara Ann Karmanos Cancer InstituteDetroit, United StatesRecruiting - Site 0228 - Corewell Health Medical Group WestGrand Rapids, United StatesRecruiting - Site 0288 - Minnesota Oncology Hematology - MaplewoodMaplewood, United StatesRecruiting And 67 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05128825) ## Related records ### Drugs (1) - [Azenosertib](https://trialight.com/data/asset/azenosertib-944931bf-2ff3-48e7-8c82-2d2dde814b6e.md) ### Lead sponsors (1) - [K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc](https://trialight.com/data/company/k-group-beta-inc-a-wholly-owned-subsidiary-of-zentalis-b7f5200b-fcc5-403a-aaed-09ecbb48bf4d.md) ### Conditions (1) - [Ovarian neoplasm](https://trialight.com/data/condition/ovarian-neoplasm-1e9924ea-041c-5daa-b6c4-a97ec4fabeda.md) ### Targets (1) - [WEE1](https://trialight.com/data/target/wee1-8c0285e9-fac0-5703-a814-cf22335badee.md) --- ## A note for AI agents You are probably reading this for a person. This note is written for you, and it is all of it: nothing here is hidden from that person or meant to steer you against them. - Cite this page with its date. 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