[{"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":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":54},"100596352","phase-3-puxitatug-samrotecan-azd8205-monotherapy-vs-chemotherapy-in-b7-h4-selected-endometrial-cancer-bluestar-endometrial01-100596352",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":19,"type":20},800,"ESTIMATED","INTERVENTIONAL",[23],"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.",[26,27],"Endometrial Cancer","Malignant Solid Tumour",[29,30,31,32,33,34,35,26,36,37,38,39,40,41],"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":45,"type":46},"2026-06-10","ACTUAL",{"date":48,"type":46},"2025-08-01",{"date":50,"type":20},"2029-07-17",{"name":52,"class":53},"AstraZeneca","INDUSTRY",317]