[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"high-grade-serous-ovarian-cancer-hgsoc\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:high-grade-serous-ovarian-cancer-hgsoc":90},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,43,76],{"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":26,"conditions":27,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100530572","phase-1-a-first-in-human-dose-escalation-and-expansion-study-to-evaluate-the-safety-and-tolerability-of-azd8421-alone-or-in-combination-in-participants-with-selected-advanced-or-metastatic-solid-tumors-100530572",false,"NCT06188520","A First-in-human Dose Escalation and Expansion Study to Evaluate the Safety, and Tolerability of AZD8421 Alone or in Combination in Participants With Selected Advanced or Metastatic Solid Tumors","A Phase I\u002FIIa, First-in-human, Open-label, Dose Escalation and Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of AZD8421 Alone or in Combination in Participants With Selected Advanced or Metastatic Solid Tumors","CYCAD-1","Inclusion Criteria:\n\n* Female participants only, aged 18 or above\n* Participants with advanced solid tumors must have received prior adequate therapy in accordance with local practice for their tumor type and stage of disease, or, in the opinion of the Investigator, a clinical study is the best option for their next treatment based on response to and\u002For tolerability of prior therapy.\n* Metastatic or locoregionally recurrent disease and radiological or objective evidence of progression on or after the last systemic therapy prior to starting IMP.\n* ECOG\u002FWHO performance status 0 to 1, and a minimum life expectancy of 12 weeks.\n* At least one lesion that is measurable and\u002For non-measurable, as per RECIST v1.1 and that can be accurately assessed at baseline and is suitable for repeated assessment.\n\nExclusion Criteria:\n\n* Intervention with any of the following:\n* Any cytotoxic chemotherapy, investigational agents, or other anti-cancer drugs for the treatment of advanced cancer from a previous treatment regimen or clinical study within 14 days or 5 half-lives (whichever is shorter) of the first dose of IMP (21 days for myelosuppressive therapies) other than GnRHa (eg, goserelin) and bone-stabilizing agents (eg, zoledronic acid, denosumab).\n* Any prescription or non-prescription drugs or other products, including herbal products, known to be moderate or strong inhibitors\u002Finducers of CYP3A4\u002F5 which cannot be discontinued prior to first dose of IMP and withheld throughout the study until 2 weeks after the last dose of study drug.\n* Drugs that have a known risk of Torsades de Pointes.\n* Radiotherapy with a limited field of radiation for palliation within 1 week of the first dose of IMP.\n* Major surgical procedure or significant traumatic injury, within 4 weeks of the first dose of IMP, or an anticipated need for major surgery and\u002For any surgery requiring general anesthesia during the study.\n* Any unresolved toxicities of Grade ≥ 2 from prior anti-cancer therapy (with the exception of alopecia). Participants with stable ≤ Grade 2 neuropathy are eligible.\n* Presence of life-threatening metastatic visceral disease, as judged by the Investigator, uncontrolled CNS metastatic disease. Participants with spinal cord compression and\u002For brain metastases may be enrolled if definitively treated (eg, surgery or radiotherapy) and stable off steroids for at least 4 weeks prior to start of IMP.\n* Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses, or eg, infection requiring IV antibiotic therapy, or active infection including hepatitis B, hepatitis C, and HIV (active viral infection is defined as requiring antiviral therapy; screening for chronic conditions is not required).\n* Any of the following cardiac criteria:\n* Mean resting QTcF \\> 470 msec obtained from a triplicate ECG\n* Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG (eg, complete left bundle branch block, second- and third-degree heart block), or clinically significant sinus pause. Participants with controlled atrial fibrillation can be enrolled.\n* Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as symptomatic heart failure, hypokalemia, congenital long QT syndrome, immediate family history of long QT syndrome or unexplained sudden death at \\\u003C 40 years of age. Hypertrophic cardiomyopathy and clinically significant stenotic valve disease.\n* LVEF \\\u003C 50%, and\u002For experience of any of the following procedures or conditions in the preceding 6 months: coronary artery bypass graft, angioplasty, vascular stent, myocardial infarction, unstable angina pectoris, congestive heart failure NYHA Grade ≥ 2, cerebrovascular accident, or transient ischemic attack.\n* Uncontrolled hypertension.\n* Inadequate bone marrow reserve or organ function as demonstrated by relevant laboratory values:\n* Refractory nausea and vomiting, uncontrolled chronic gastrointestinal diseases, or previous significant bowel resection that would preclude adequate absorption of IMP(s).\n* History of hypersensitivity to active or inactive excipients of AZD8421 or drugs with a similar chemical structure or class to AZD8421.\n* Previous treatment with AZD8421 or with any CDK2-selective inhibitor, or protein kinase membrane-associated tyrosine- and threonine-specific cdc2-inhibitory kinase 1 (PKMYT1) inhibitor, or WEE1 inhibitor.\n* Currently pregnant (confirmed with positive pregnancy test), breast feeding, or planning to become pregnant. Participants of childbearing potential must agree to use one highly effective contraceptive measure.","FEMALE","18 Years",{"count":20,"type":21},564,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","This study is designed to evaluate AZD8421 alone and in combination with selected targeted anti-cancer drugs in patients with ER+HER2- advanced breast cancer, and patients with metastatic high-grade serious ovarian cancer.",[28,29],"ER+ HER2- Advanced Breast Cancer","High-grade Serous Ovarian Cancer (HGSOC)","RECRUITING","2026-06-22",{"date":33,"type":34},"2026-06-23","ACTUAL",{"date":36,"type":34},"2023-12-05",{"date":38,"type":21},"2027-08-04",{"name":40,"class":41},"AstraZeneca","INDUSTRY",14,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":53,"conditions":54,"keywords":57,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":4},"100626204","phase-2-neoadjuvant-aitua-pd-1ctla-4-bispecific-plus-nab-paclitaxel-and-carboplatin-for-advanced-high-grade-serous-ovarian-cancer-100626204","NCT07432594","Neoadjuvant Aitua (PD-1\u002FCTLA-4 Bispecific) Plus Nab-Paclitaxel and Carboplatin for Advanced High-Grade Serous Ovarian Cancer","A Prospective, Randomized, Controlled Phase II Clinical Study of Albumin-Bound Paclitaxel\u002FCarboplatin Combined With Aitua Combination Antibody (PD-1\u002FCTLA-4 Bispecific Antibody) for the Neoadjuvant Treatment of Advanced High-Grade Serous Ovarian Cancer With Unsatisfactory Debulking","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Histologically confirmed high-grade serous ovarian cancer (HGSC), fallopian tube cancer, or primary peritoneal cancer.\n* International Federation of Gynecology and Obstetrics (FIGO) stage IIIC-IV.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n* Assessed by a multidisciplinary team (MDT) based on imaging (± laparoscopic exploration) as initially unable to achieve satisfactory tumor debulking (R0 resection).\n* At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria.\n* Major organ function is basically normal.\n* Willing to provide tumor tissue, peripheral blood, and ascites samples for translational research.\n\nExclusion Criteria:\n\n* Pathological types other than high-grade serous carcinoma (HGSC).\n* Prior receipt of any form of anti-tumor therapy.\n* History of autoimmune disease or requiring immunosuppressive therapy.\n* Known allergy to study drug components.\n* Pregnant or lactating women.",{"count":51,"type":21},82,[25],"This is a prospective, randomized, controlled Phase II clinical study designed to evaluate the efficacy and safety of adding Aitua Combination Antibody (a PD-1\u002FCTLA-4 bispecific antibody) to standard neoadjuvant chemotherapy for patients with advanced high-grade serous ovarian cancer.\n\nThe study focuses on patients who are newly diagnosed with Stage IIIC-IV ovarian, fallopian tube, or primary peritoneal cancer and are assessed as unable to achieve satisfactory tumor debulking (R0 resection) initially.\n\nParticipants will be randomized in a 1:1 ratio into two groups:\n\nExperimental Group: Receives Nab-paclitaxel and Carboplatin combined with Aitua Combination Antibody.\n\nControl Group: Receives Nab-paclitaxel and Carboplatin alone.\n\nBoth groups will receive 3 cycles of neoadjuvant treatment followed by Interval Debulking Surgery (IDS). The primary goal is to compare the R0 resection rate (complete removal of macroscopic tumor) between the two groups during surgery. Secondary goals include assessing pathological complete response (pCR), objective response rate, progression-free survival, and safety. The study also aims to explore how this combination therapy affects the tumor immune microenvironment.",[29,55,56],"Fallopian Tube Cancers","Primary Peritoneal Cancer",[58,59,60,61,62,63,64],"Neoadjuvant Chemotherapy","Interval Debulking Surgery","PD-1\u002FCTLA-4 Bispecific Antibody","Aitua Combination Antibody","Nab-paclitaxel","Carboplatin","Immunotherapy","NOT_YET_RECRUITING","2026-02-21",{"date":68,"type":34},"2026-02-25",{"date":70,"type":21},"2026-03-01",{"date":72,"type":21},"2027-06-30",{"name":74,"class":75},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences","OTHER",{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":22,"phases":86,"briefSummary":88,"conditions":89,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":4},"100512718","68ga-fapi-petct-in-the-staging-of-high-grade-epithelial-ovarian-cancers-a-pilot-study-100512718","NCT05956093","68Ga-FAPI PET\u002FCT in the Staging of High-Grade Epithelial Ovarian Cancers: A Pilot Study","FAST HOC-FAPI PET for Staging of High-Grade Serous Ovarian Cancer .","FAST HOC","Inclusion Criteria:\n\n* Patients will be eligible for inclusion in this study if they meet the following criteria:\n\n  * Age ≥18 years.\n  * Cytological or histological diagnosis of HGSOC, or clinical suspicion of HGSOC based on symptoms, physical exam, tumour markers, and imaging findings.\n  * Clinical stage III or IV, being considered for PCS or NACT.\n  * Contrast-enhanced CT abdomen and pelvis within 6 weeks of PET (prior to enrolment).\n\nExclusion Criteria:\n\nPatients will be ineligible to participate in this study if they meet any of the following criteria:\n\n* Inability to provide informed consent.\n* Contraindications for PET examination as per institutional safety guidelines, including but not limited to pregnancy, or inability to lie still for PET examination.\n* Evidence of the following epithelial ovarian cancer histological subtypes: Mucinous, low-grade serous, low-grade endometrioid, and low-malignant potential tumours.\n* Non-ovarian advanced gynecological malignancy",{"count":85,"type":21},30,[87],"NA","The investigator will use a technology called PET-CT that combines a Positron Emission Tomography (PET) scan with a computed tomography (CT) scan. This combined imaging test, where PET and CT data are gathered at one time, will be performed on an integrated PET-CT scanner located at Princess Margaret Cancer Centre.\n\nThe purpose of this study is to find out if the use of 68Ga-PNT6555 (FAPI) PET-CT will improve the assessment of disease extent as compared to routine CT scans.",[90],"High Grade Serous Ovarian Cancer (HGSOC)","2025-08-14",{"date":93,"type":34},"2025-08-15",{"date":95,"type":21},"2025-09-25",{"date":97,"type":21},"2026-05-30",{"name":99,"class":75},"University Health Network, Toronto"]