[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":97},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,43,69],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100449157","phase-2-a-study-of-azenosertib-zn-c3-in-subjects-with-platinum-resistant-high-grade-serous-ovarian-fallopian-tube-or-primary-peritoneal-cancer-100449157",false,"NCT05128825","A Study of Azenosertib (ZN-c3) in Subjects With Platinum-Resistant High-Grade Serous Ovarian, Fallopian Tube or Primary Peritoneal Cancer","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 \u002F ZN-c3-005 \u002F GOG-3066)","DENALI","Inclusion Criteria:\n\n1. Age ≥18 years\n2. High-grade serous ovarian, fallopian tube or primary peritoneal cancer\n3. Tumor testing (archival acceptable) confirms a positive Cyclin E1 protein status result determined by IHC using the Sponsor's investigational clinical trial assay\n4. Prior therapy:\n\n   1. Subjects must have platinum-resistant disease\n   2. Parts 2a and 2b: One to 3 prior lines or regimens are allowed (1 to 4 prior lines are permitted, if prior mirvetuximab)\n   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\n   4. Prior bevacizumab treatment is required, if eligible per standard of care\n   5. Prior PARP inhibitor treatment is required if BRCA 1\u002F2 mutation or HRD, if eligible per standard of care\n   6. Prior mirvetuximab treatment is required, if eligible per standard of care\n5. Measurable disease per RECIST Version 1.1.\n6. Adequate hematologic and organ function, as defined in protocol\n7. ECOG 0-1\n\nExclusion Criteria:\n\n1. Primary platinum-refractory disease\n2. Subjects with endometrioid, clear cell, mucinous, or sarcomatous histology, mixed tumors containing any of the above histologies, low-grade, borderline, or other ovarian tumors\n3. Any of the following treatment interventions within the specified time frame prior to C1D1:\n\n   1. Major surgery within 28 days\n   2. Hospitalization within 14 days\n   3. Any chemotherapy or targeted tumor therapy within 21 days or 5 half-lives (whichever is shorter);\n   4. Radiation therapy within 21 days;\n   5. Autologous or allogeneic stem cell transplant within 3 months.\n   6. Current use of any other investigational drug therapy \\\u003C28 days or 5 half-lives (whichever is shorter).\n   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.\n4. Prior therapy with ZN-c3 or any other WEE1 inhibitor, ATR inhibitor, PKMYT1 inhibitor, or CHK1\u002F2 inhibitor.\n5. A serious illness or medical condition(s) including, but not limited to:\n\n   1. Clinically or radiographically unstable brain metastases or leptomeningeal disease that requires immediate treatment. Subjects with asymptomatic brain metastases are eligible.\n   2. Myocardial impairment resulting in heart failure (NYHA Class II-IV)\n   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\n   4. Acute kidney injury requiring intervention or intravenous fluid in the last 14 days or presence of indwelling urinary catheter or percutaneous nephrostomy.\n   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.\n   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\u002Fresolved (and afebrile) by the Investigator for at least 7 days before C1D1\n   7. Any evidence of bowel obstruction as determined by air\u002Ffluid 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.\n6. Unresolved toxicity of Grade \\>1 attributed to any prior therapies (excluding Grade ≤2 neuropathy, alopecia, or skin pigmentation).\n7. Pregnant or lactating female subject or female subject of childbearing potential who has a positive serum pregnancy test within 14 days prior to C1D1.\n8. 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.\n9. Subjects who are known to be immunocompromised or HIV-positive on highly active anti-retroviral therapy.\n10. Subjects with known active hepatitis B or hepatitis C infection.\n11. Individuals who are judged by the Investigator to be unsuitable as study subjects.\n12. Subjects who had prior wide-field radiotherapy affecting ≥ 20% of the bone marrow.","FEMALE","18 Years",{"count":20,"type":21},310,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","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.",[27],"High-Grade Serous Ovarian, Fallopian Tube or Primary Peritoneal Cancer",[29],"Cyclin E1, CCNE1, Ovarian Cancer, Platinum Resistant, WEE1 inhibitor, DENALI, GOG-3066","RECRUITING","2026-06-29",{"date":33,"type":34},"2026-07-01","ACTUAL",{"date":36,"type":34},"2022-02-17",{"date":38,"type":21},"2027-06-30",{"name":40,"class":41},"K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc","INDUSTRY",92,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":68},"100634962","phase-3-a-study-of-azenosertib-zn-c3-versus-investigators-choice-chemotherapy-in-subjects-with-platinum-resistant-high-grade-serous-ovarian-primary-peritoneal-or-fallopian-tube-cancers-positive-for-cyclin-e1-protein-expression-100634962","NCT07546500","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 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","ASPENOVA","Inclusion Criteria:\n\n1. Female age ≥ 18 years\n2. High-grade serous epithelial ovarian, primary peritoneal, or fallopian tube cancer\n3. Measurable disease per RECIST Version 1.1\n4. Eastern Cooperative Oncology Group (ECOG) performance status score 0-1\n5. 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\n6. Prior Therapy:\n\n   1. Subject must have platinum-resistant disease\n   2. One to 3 prior lines or regimens are allowed (1 to 4 prior lines are permitted, if prior mirvetuximab)\n   3. Prior bevacizumab treatment is required, if eligible per standard of care\n   4. Prior PARP inhibitor treatment is required if BRCA 1\u002F2 mutation or HRD, if eligible per standard of care\n   5. Prior mirvetuximab treatment is required, if eligible per standard of care\n7. Adequate hematologic and organ function during the screening period\n\nExclusion Criteria:\n\n1. 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.\n2. Subjects with primary platinum-refractory disease.\n3. Prior therapy with azenosertib or any other WEE1 inhibitor, ATR inhibitor, CHK1\u002F2 inhibitor, or (PKMYT1) inhibitor for PROC.\n4. A serious illness or medical condition(s) including, but not limited to, the following:\n\n   1. Clinically or radiographically unstable brain metastases or leptomeningeal disease that requires immediate treatment. Subjects with asymptomatic brain metastases are eligible.\n   2. Acute kidney injury requiring intervention, or presence of indwelling urinary catheter or percutaneous nephrostomy.\n   3. 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.\n   4. Any evidence of small bowel obstruction as determined by air\u002Ffluid 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.\n   5. 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\u002Fresolved (and afebrile) by the Investigator for at least 7 days before randomization\n   6. Myocardial impairment of any cause resulting in heart failure by New York Heart Association criteria (Class II, III or IV).\n   7. 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\n5. Any of the following treatment interventions within the specified time frame before randomization:\n\n   1. Hospitalization within 14 days\n   2. Major surgery within 28 days\n   3. Any chemotherapy or targeted tumor therapy within 21 days or 5 half-lives (whichever is shorter)\n   4. Radiation therapy within 21 days\n   5. Autologous or allogeneic stem cell transplant within 3 months\n   6. Current use of any other investigational drug therapy \\\u003C 28 days or 5 half-lives (whichever is shorter)\n6. Inability to discontinue treatment with prescription or nonprescription drugs that are prohibited per protocol.\n7. Inability to discontinue consumption of food and herbal supplements that are prohibited per protocol\n8. Prior wide-field radiotherapy affecting ≥ 20% of the bone marrow.\n9. Unresolved toxicity of Grade \\> 1 attributed to any prior therapies (excluding Grade ≤ 2 neuropathy, alopecia, or skin pigmentation).\n10. Subjects who are immunocompromised or HIV-positive on highly active anti-retroviral therapy\n11. Subjects with known active hepatitis B or hepatitis C infection\n12. Individuals who are judged by the Investigator to be unsuitable as study subjects",{"count":52,"type":21},420,[54],"PHASE3","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.",[57],"Ovarian Cancer",[59,60],"Platinum-Resistant Ovarian Cancer (PROC)","OvCa","2026-06-26",{"date":31,"type":34},{"date":64,"type":34},"2026-04-17",{"date":66,"type":21},"2030-04-30",{"name":40,"class":41},58,{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":77,"targetDuration":4,"studyType":22,"phases":79,"briefSummary":81,"conditions":82,"keywords":87,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},"100402145","phase-1-a-study-of-azenosertib-zn-c3-in-patients-with-ovarian-cancer-100402145","NCT04516447","A Study of Azenosertib (ZN-c3) in Patients With Ovarian Cancer","A Phase 1b Study of ZN-c3 in Combination With Chemotherapy or Bevacizumab in Subjects With Ovarian, Peritoneal, or Fallopian Tube Cancer","MUIR","INCLUSION CRITERIA:\n\nFor Part 1:\n\n* Histologically or cytologically confirmed FIGO Stage III\u002FIV high-grade serous or endometrioid ovarian, fallopian tube, or peritoneal carcinoma.\n* Subjects must have received 1 or 2 prior therapeutic regimens\u002Flines of therapy in the advanced or metastatic setting. At least one regimen must have contained cisplatin or carboplatin.\n* The disease must be platinum resistant (ie, the PFI must have been \\\u003C 6 months). Platinum refractory disease (ie, PD during first-line platinum-based therapy) is allowed.\n\nFor Part 2 Dose Escalation:\n\nPrior therapy:\n\n• Subjects must have received 6 cycles of platinum-based doublet chemotherapy in the 1L or 2L setting as their most recent therapy\n\nResponse to prior platinum therapy:\n\n1. In the 1L setting: Complete Response, Partial Response, or Stable Disease to platinum-based chemotherapy.\n2. In the 2L setting:\n\n   1. Progressive Disease \\>183 days after receiving the last dose of platinum chemotherapy in the 1L setting,\n   2. Complete Response, Partial Response, or Stable Disease to 2L platinum-based chemotherapy.\n\n      * Adequate hematologic, and organ function\n\nFor Part 2 Dose Expansion:\n\n* Subjects must have at least 4 cycles of platinum-based chemotherapy in 2L and have Complete Response, Partial Response, or Stable Disease\n* Subjects must have progressed while on a PARP inhibitor for 1L maintenance Additional protocol-defined inclusion criteria may apply\n\nEXCLUSION CRITERIA:\n\n* Histology of abdominal adenocarcinoma of unknown origin or diagnosis of a borderline ovarian tumor.\n* Subjects with carcinosarcomas (even if there is a serous component)\n* A serious illness or medical condition(s)\n* Subjects with active (uncontrolled, metastatic) second malignancies or requiring therapy.\n\nAdditional protocol-defined exclusion criteria may apply",{"count":78,"type":21},172,[80],"PHASE1","This is a Phase 1b open-label, multicenter study, evaluating the safety, tolerability, preliminary clinical activity, pharmacokinetics (PK), and pharmacodynamics of azenosertib (ZN-c3) in combination with other drugs.",[83,84,85,86],"Solid Tumor","Epithelial Ovarian Cancer","Fallopian Tube Cancer","Peritoneal Cancer",[83],"2026-04-01",{"date":90,"type":34},"2026-04-07",{"date":92,"type":34},"2020-10-26",{"date":94,"type":21},"2028-06-30",{"name":40,"class":41},24,""]