[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"malignant-solid-tumour\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:malignant-solid-tumour":54},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":27,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":53},"100596352",false,"NCT07044336","Puxitatug Samrotecan (AZD8205) Monotherapy vs Chemotherapy in B7-H4-selected Endometrial Cancer (Bluestar-Endometrial01)","Puxitatug Samrotecan (AZD8205) Monotherapy vs Chemotherapy in B7-H4 Selected Advanced\u002FMetastatic Endometrial Cancer Who Progressed On or After Platinum Based Chemotherapy and Anti-PD-1\u002FAnti-PD-L1 Therapy (Bluestar-Endometrial01)","The main inclusion criteria include but are not limited to the following:\n\n* Histologically confirmed diagnosis of endometrial carcinoma or carcinosarcoma.\n* Recurrent\u002Fmetastatic EC ie, with radiological or objective evidence of recurrence or progression.\n* Has received prior platinum-based chemotherapy and anti-programmed cell death 1 protein (PD-1)\u002Fanti- programmed cell death ligand 1 (PD-L1) therapy, either separately or in combination.\n* A WHO\u002FECOG performance status of 0 or 1 at Screening.\n* Has radiographically measurable disease by RECIST 1.1\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Had uterine sarcomas or uterine neuroendocrine carcinoma.\n* Has had a recurrence of endometrial carcinoma or carcinosarcoma more than \\> 12 months after completing platinum-based therapy administered in the curative-intent setting without any additional platinum-based therapy received in the recurrent setting.\n* Had previously received treatment with any therapy (approved or investigational) that contained a TOP1i including ADCs .\n* Had previously received treatment with Puxi-Sam or another B7-H4 targeting agent.\n* History of (non-infectious) ILD\u002Fpneumonitis that required steroids, has current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at screening.\n* Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses.\n* Active or previously documented autoimmune or inflammatory disorders","FEMALE","18 Years",{"count":18,"type":19},800,"ESTIMATED","INTERVENTIONAL",[22],"PHASE3","This is a Phase III, 2-arm, randomized, open label, multicenter, global study assessing the efficacy and safety of puxitatug samrotecan compared to physician's choice of chemotherapy (doxorubicin or paclitaxel) in participants with B7-H4 selected advanced\u002Fmetastatic EC that progressed following platinum based chemotherapy and anti-PD-1\u002Fanti-PD-L1 therapy.",[25,26],"Endometrial Cancer","Malignant Solid Tumour",[28,29,30,31,32,33,34,25,35,36,37,38,39,40],"Bluestar-Endometrial01","AZD8205","Puxitatug Samrotecan","Puxi-Sam","Platinum-based chemotherapy","B7-H4","advanced\u002Fmetastatic","Anti-PD-1","Anti-PD-L1","antibody-drug conjugate","Topoisomerase 1 Inhibitors","uterine neoplasm","female urogenital neoplasm","RECRUITING","2026-06-09",{"date":44,"type":45},"2026-06-10","ACTUAL",{"date":47,"type":45},"2025-08-01",{"date":49,"type":19},"2029-07-17",{"name":51,"class":52},"AstraZeneca","INDUSTRY",317,""]