[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100623056":3},{"organization":4,"outcomesModule":7,"designInfo":48,"detailedDescription":54,"studyPopulation":47,"armGroups":55,"interventions":72,"overallOfficials":47,"centralContacts":88,"locations":94,"responsibleParty":248,"collaborators":47,"id":250,"slug":251,"hasResults":252,"nctId":253,"briefTitle":254,"officialTitle":255,"acronym":256,"eligibilityCriteria":257,"healthyVolunteers":252,"sex":258,"minAge":259,"maxAge":47,"enrollmentInfo":260,"targetDuration":47,"studyType":263,"phases":264,"briefSummary":266,"conditions":267,"keywords":269,"overallStatus":125,"whyStopped":47,"lastUpdateSubmitDate":280,"lastUpdatePostDateStruct":281,"startDateStruct":284,"completionDateStruct":286,"leadSponsor":288,"locationsCount":289},{"fullName":5,"class":6},"AstraZeneca","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":47},[9,13],{"measure":10,"description":11,"timeFrame":12},"Area under the concentration-time curve","To characterise the AUC of SC durvalumab.","From first dose of study intervention (Day 1), at predefined intervals throughout the administration of durvalumab (approximately 17 months).",{"measure":14,"description":15,"timeFrame":12},"Observed lowest concentration before the next dose is administered (Ctrough)","To characterise the Ctrough of SC durvalumab",[17,20,23,26,29,32,35,38,41,45],{"measure":18,"description":19,"timeFrame":12},"Area under the concentration-time curve from time 0 to last quantifiable concentration (AUClast)","To characterise the AUClast of SC durvalumab.",{"measure":21,"description":22,"timeFrame":12},"Maximum observed concentration (Cmax)","To characterise the Cmax of SC durvalumab.",{"measure":24,"description":25,"timeFrame":12},"Time to reach maximum concentration following drug administration (tmax)","To characterise the tmax of SC durvalumab.",{"measure":27,"description":28,"timeFrame":12},"Terminal elimination half-life (t1\u002F2λz)","To characterise the t1\u002F2λz of SC durvalumab.",{"measure":30,"description":31,"timeFrame":12},"Total body clearance\u002Fapparent total body clearance (CL[\u002FF])","To characterise the CL(\u002FF) of SC durvalumab.",{"measure":33,"description":34,"timeFrame":12},"Apparent volume of distribution based on the terminal phase volume (Vz[\u002FF])","To characterise the VZ(\u002FF) of SC durvalumab.",{"measure":36,"description":37,"timeFrame":12},"Average drug concentration over a dosing interval (Cavg)","To characterise the Cavg of SC durvalumab.",{"measure":39,"description":40,"timeFrame":12},"Serum concentration of durvalumab","To characterise the serum concentration of SC durvalumab at specified timepoints.",{"measure":42,"description":43,"timeFrame":44},"Number of participants with adverse events (AEs)","To assess the safety and tolerability of SC durvalumab.","Up to Survival Follow-up (approximately 17 months)",{"measure":46,"description":43,"timeFrame":44},"Number of participants with dose-limiting toxicities (DLTs)",null,{"allocation":49,"interventionModel":50,"interventionModelDescription":47,"primaryPurpose":51,"observationalModel":47,"timePerspective":47,"maskingInfo":52},"RANDOMIZED","SEQUENTIAL","TREATMENT",{"masking":53,"maskingDescription":47,"whoMasked":47},"NONE","This is a Phase I, multicentre study that will consist of 2 parts -\n\n* Part 1: Dose Escalation\n* Part 2: Dose Expansion\n\nPart 1 may include participants with solid tumours - non-small cell lung cancer (NSCLC), hepatocellular carcinoma (HCC) or limited-stage small cell lung cancer (LS-SCLC). It will further consist of 2 planned dose levels of SC durvalumab - Dose level 1 (DL1) and Dose level 2 (DL2).\n\nPart 2 will include participants with unresectable HCC. It will be initiated once a dose has been identified based on Part 1.",[56,64,68],{"label":57,"type":58,"description":59,"interventionNames":60},"Part 1: SC Durvalumab DL1","EXPERIMENTAL","Participants will receive DL1 of SC durvalumab + rHu followed by IV durvalumab at predefined intervals.",[61,62,63],"Drug: SC durvalumab + rHu","Drug: IV durvalumab","Drug: Tremelimumab",{"label":65,"type":58,"description":66,"interventionNames":67},"Part 1: SC Durvalumab DL2","Participants will receive DL2 of SC durvalumab + rHu followed by IV durvalumab at predefined intervals.",[61,62,63],{"label":69,"type":58,"description":70,"interventionNames":71},"Part 2: Expansion Cohort, SC Durvalumab Dose Level X","Participants will receive dose level X (determined from data analysis in Part 1) of SC durvalumab + rHu followed by IV durvalumab at predefined intervals.",[61,62,63],[73,78,84],{"type":74,"name":75,"description":76,"armGroupLabels":77,"otherNames":47},"DRUG","SC durvalumab + rHu","Durvalumab + rHu will be administered subcutaneously.",[57,65,69],{"type":74,"name":79,"description":80,"armGroupLabels":81,"otherNames":82},"IV durvalumab","Durvalumab will be administered intravenously.",[57,65,69],[83],"MEDI4736",{"type":74,"name":85,"description":86,"armGroupLabels":87,"otherNames":47},"Tremelimumab","Tremelimumab will be administered to participants with unresectable HCC as an IV infusion.",[57,65,69],[89],{"name":90,"role":91,"phone":92,"phoneExt":47,"email":93},"AstraZeneca Clinical Study Information Center","CONTACT","1-877-240-9479","information.center@astrazeneca.com",[95,108,116,124,135,143,148,158,166,174,182,190,199,207,212,217,227,235,240],{"facility":96,"status":97,"city":98,"state":47,"zip":99,"country":100,"countryCode":101,"cosmosGeoPoint":102,"geoPoint":107,"contacts":47},"Research 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Korea",{"type":103,"coordinates":195},[196,197],127.13778,37.43861,{"lat":197,"lon":196},{"facility":96,"status":125,"city":200,"state":47,"zip":201,"country":193,"countryCode":47,"cosmosGeoPoint":202,"geoPoint":206,"contacts":47},"Seoul","03722",{"type":103,"coordinates":203},[204,205],126.9784,37.566,{"lat":205,"lon":204},{"facility":96,"status":125,"city":200,"state":47,"zip":208,"country":193,"countryCode":47,"cosmosGeoPoint":209,"geoPoint":211,"contacts":47},"06351",{"type":103,"coordinates":210},[204,205],{"lat":205,"lon":204},{"facility":96,"status":125,"city":200,"state":47,"zip":213,"country":193,"countryCode":47,"cosmosGeoPoint":214,"geoPoint":216,"contacts":47},"5505",{"type":103,"coordinates":215},[204,205],{"lat":205,"lon":204},{"facility":96,"status":125,"city":218,"state":47,"zip":219,"country":220,"countryCode":221,"cosmosGeoPoint":222,"geoPoint":226,"contacts":47},"Tainan","73657","Taiwan","TW",{"type":103,"coordinates":223},[224,225],120.21333,22.99083,{"lat":225,"lon":224},{"facility":96,"status":125,"city":228,"state":47,"zip":229,"country":220,"countryCode":221,"cosmosGeoPoint":230,"geoPoint":234,"contacts":47},"Taipei","110",{"type":103,"coordinates":231},[232,233],121.52639,25.05306,{"lat":233,"lon":232},{"facility":96,"status":97,"city":228,"state":47,"zip":236,"country":220,"countryCode":221,"cosmosGeoPoint":237,"geoPoint":239,"contacts":47},"112",{"type":103,"coordinates":238},[232,233],{"lat":233,"lon":232},{"facility":96,"status":97,"city":241,"state":47,"zip":242,"country":220,"countryCode":221,"cosmosGeoPoint":243,"geoPoint":247,"contacts":47},"Taoyuan","333",{"type":103,"coordinates":244},[245,246],121.29696,24.99368,{"lat":246,"lon":245},{"type":249,"investigatorFullName":47,"investigatorTitle":47,"investigatorAffiliation":47,"oldNameTitle":47,"oldOrganization":47},"SPONSOR","100623056","phase-1-a-phase-i-dose-escalation-and-dose-expansion-study-to-investigate-the-pharmacokinetics-and-safety-of-subcutaneous-durvalumab-100623056",false,"NCT07391670","A Phase I Dose Escalation and Dose Expansion Study to Investigate the Pharmacokinetics and Safety of Subcutaneous Durvalumab","A Phase I, Multicentre, Dose Escalation and Dose Expansion Study to Investigate the Pharmacokinetics and Safety of Subcutaneous Durvalumab in Adult Participants With Solid Tumours","IMFINZI-subQ","Inclusion Criteria:\n\n* An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Life expectancy of ≥ 12 weeks at enrolment.\n* Adequate organ and marrow function.\n* Minimum body weight \\> 30 kg.\n\nPart 1 only:\n\nLocally Advanced Unresectable (Stage III) NSCLC Participants -\n\n* Histological or cytological documented evidence of NSCLC (locally advanced, unresectable, Stage III).\n* Must have received at least 2 cycles of platinum-based chemotherapy concurrent with definitive radiation therapy.\n* Have not progressed following definitive concurrent chemoradiation.\n\nLS-SCLC Participants -\n\n* Histologically or cytologically documented LS-SCLC (Stage I-III).\n* Received 4 cycles of chemotherapy concurrent with radiotherapy, which must be completed within 1 to 42 days prior to enrolment.\n* Have not progressed following definitive concurrent chemoradiation.\n\nPart 1 and 2:\n\nUnresectable HCC Participants -\n\n* Unresectable HCC based on histopathological confirmation.\n* No prior systemic therapy for unresectable HCC.\n* Must not be eligible for locoregional therapy for unresectable HCC.\n* Child-Pugh Score class A.\n* Measurable disease as defined by RECIST v1.1.\n\nExclusion Criteria:\n\n* Active or prior documented autoimmune disease requiring systemic treatment.\n* Uncontrolled infection (including human immunodeficiency virus \\[HIV\\], hepatitis B or C).\n* Prior exposure to immune checkpoint inhibitors.\n\nPart 1 only:\n\nLocally Advanced Unresectable (Stage III) NSCLC Participants -\n\n* Mixed SCLC and NSCLC histology.\n* Active pneumonitis or interstitial lung disease requiring systemic therapy.\n\nLS SCLC Participants -\n\n* Mixed SCLC and NSCLC histology.\n* Extensive-stage disease.\n* History of Grade ≥ 2 pneumonitis.\n\nPart 1 and 2:\n\nUnresectable HCC Participants -\n\n* Hepatic encephalopathy.\n* Uncontrolled ascites.\n* Active gastrointestinal (GI) bleeding.","ALL","18 Years",{"count":261,"type":262},40,"ESTIMATED","INTERVENTIONAL",[265],"PHASE1","The purpose of the study is to determine a subcutaneous (SC: under the skin) durvalumab + recombinant human hyaluronidase (rHu) dose that yields systemic drug exposure similar to intravenous (IV: into the veins) durvalumab administration and to evaluate the pharmacokinetics and safety of SC durvalumab + rHu injection in participants with different types of solid tumours (cancers).",[268],"Solid Tumours",[270,271,272,273,274,275,276,277,278,279],"Pharmacokinetics","Non-small cell lung cancer (Stage III, unresectable)","Small cell lung cancer (Limited stage)","Hepatocellular carcinoma (Unresectable)","Subcutaneous","Human hyaluronidase","Monoclonal antibody","Programmed cell death ligand 1 (PD-L1)","Programmed cell death protein 1","Anticancer therapy","2026-08-24",{"date":282,"type":283},"2026-08-25","ACTUAL",{"date":285,"type":283},"2026-03-31",{"date":287,"type":262},"2027-08-30",{"name":5,"class":6},19]