[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100562219":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":38,"centralContacts":42,"locations":50,"responsibleParty":247,"collaborators":31,"id":249,"slug":31,"hasResults":250,"nctId":251,"briefTitle":252,"officialTitle":253,"acronym":31,"eligibilityCriteria":254,"healthyVolunteers":250,"sex":255,"minAge":256,"maxAge":31,"enrollmentInfo":257,"targetDuration":31,"studyType":260,"phases":261,"briefSummary":263,"conditions":264,"keywords":267,"overallStatus":53,"whyStopped":31,"lastUpdateSubmitDate":275,"lastUpdatePostDateStruct":276,"startDateStruct":279,"completionDateStruct":281,"leadSponsor":283,"locationsCount":284},{"fullName":5,"class":6},"Alnylam Pharmaceuticals","INDUSTRY",[8,14,17,22],{"label":9,"type":10,"description":11,"interventionNames":12},"Monotherapy: Dose Escalation","EXPERIMENTAL","Patients will be administered multiple doses of ALN-BCAT.",[13],"Drug: ALN-BCAT",{"label":15,"type":10,"description":11,"interventionNames":16},"Monotherapy: Dose Expansion",[13],{"label":18,"type":10,"description":19,"interventionNames":20},"Combination Therapy: Dose Escalation","Patients will be administered multiple doses of ALN-BCAT in combination with pembrolizumab.",[13,21],"Drug: Pembrolizumab",{"label":23,"type":10,"description":19,"interventionNames":24},"Combination Therapy: Dose Expansion",[13,21],[26,32],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DRUG","ALN-BCAT","Administered by intravenous (IV) infusion",[18,23,9,15],null,{"type":27,"name":33,"description":29,"armGroupLabels":34,"otherNames":35},"Pembrolizumab",[18,23],[36,37],"Keytruda","MK-3475",[39],{"name":40,"affiliation":5,"role":41},"Medical Director","STUDY_DIRECTOR",[43,48],{"name":44,"role":45,"phone":46,"phoneExt":31,"email":47},"Alnylam Clinical Trial Information Line","CONTACT","1-877-ALNYLAM","clinicaltrials@alnylam.com",{"name":44,"role":45,"phone":49,"phoneExt":31,"email":47},"1-877-256-9526",[51,64,73,81,90,99,108,117,126,134,140,149,158,167,175,183,192,201,209,217,226,234,239],{"facility":52,"status":53,"city":54,"state":55,"zip":56,"country":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":31},"Clinical Trial Site","RECRUITING","Phoenix","Arizona","85054","United States",{"type":59,"coordinates":60},"Point",[61,62],-112.07404,33.44838,{"lat":62,"lon":61},{"facility":52,"status":53,"city":65,"state":66,"zip":67,"country":57,"cosmosGeoPoint":68,"geoPoint":72,"contacts":31},"La Jolla","California","92037",{"type":59,"coordinates":69},[70,71],-117.2742,32.84727,{"lat":71,"lon":70},{"facility":52,"status":53,"city":74,"state":66,"zip":75,"country":57,"cosmosGeoPoint":76,"geoPoint":80,"contacts":31},"Los Angeles","90033",{"type":59,"coordinates":77},[78,79],-118.24368,34.05223,{"lat":79,"lon":78},{"facility":52,"status":53,"city":82,"state":83,"zip":84,"country":57,"cosmosGeoPoint":85,"geoPoint":89,"contacts":31},"Jacksonville","Florida","32224",{"type":59,"coordinates":86},[87,88],-81.65565,30.33218,{"lat":88,"lon":87},{"facility":52,"status":53,"city":91,"state":92,"zip":93,"country":57,"cosmosGeoPoint":94,"geoPoint":98,"contacts":31},"Atlanta","Georgia","30322",{"type":59,"coordinates":95},[96,97],-84.38798,33.749,{"lat":97,"lon":96},{"facility":52,"status":53,"city":100,"state":101,"zip":102,"country":57,"cosmosGeoPoint":103,"geoPoint":107,"contacts":31},"Chicago","Illinois","60637",{"type":59,"coordinates":104},[105,106],-87.65005,41.85003,{"lat":106,"lon":105},{"facility":52,"status":53,"city":109,"state":110,"zip":111,"country":57,"cosmosGeoPoint":112,"geoPoint":116,"contacts":31},"Ann Arbor","Michigan","48109",{"type":59,"coordinates":113},[114,115],-83.74088,42.27756,{"lat":115,"lon":114},{"facility":52,"status":53,"city":118,"state":119,"zip":120,"country":57,"cosmosGeoPoint":121,"geoPoint":125,"contacts":31},"Rochester","Minnesota","55905",{"type":59,"coordinates":122},[123,124],-92.4699,44.02163,{"lat":124,"lon":123},{"facility":52,"status":53,"city":127,"state":127,"zip":128,"country":57,"cosmosGeoPoint":129,"geoPoint":133,"contacts":31},"New York","10029",{"type":59,"coordinates":130},[131,132],-74.00597,40.71427,{"lat":132,"lon":131},{"facility":52,"status":135,"city":127,"state":127,"zip":136,"country":57,"cosmosGeoPoint":137,"geoPoint":139,"contacts":31},"COMPLETED","10032",{"type":59,"coordinates":138},[131,132],{"lat":132,"lon":131},{"facility":52,"status":53,"city":141,"state":142,"zip":143,"country":57,"cosmosGeoPoint":144,"geoPoint":148,"contacts":31},"Cleveland","Ohio","44106",{"type":59,"coordinates":145},[146,147],-81.69541,41.4995,{"lat":147,"lon":146},{"facility":52,"status":53,"city":150,"state":151,"zip":152,"country":57,"cosmosGeoPoint":153,"geoPoint":157,"contacts":31},"Pittsburgh","Pennsylvania","15232",{"type":59,"coordinates":154},[155,156],-79.99589,40.44062,{"lat":156,"lon":155},{"facility":52,"status":53,"city":159,"state":160,"zip":161,"country":57,"cosmosGeoPoint":162,"geoPoint":166,"contacts":31},"Dallas","Texas","75390",{"type":59,"coordinates":163},[164,165],-96.80667,32.78306,{"lat":165,"lon":164},{"facility":52,"status":53,"city":168,"state":160,"zip":169,"country":57,"cosmosGeoPoint":170,"geoPoint":174,"contacts":31},"Houston","77030",{"type":59,"coordinates":171},[172,173],-95.36327,29.76328,{"lat":173,"lon":172},{"facility":52,"status":53,"city":176,"state":160,"zip":177,"country":57,"cosmosGeoPoint":178,"geoPoint":182,"contacts":31},"San Antonio","78229",{"type":59,"coordinates":179},[180,181],-98.49363,29.42412,{"lat":181,"lon":180},{"facility":52,"status":53,"city":184,"state":185,"zip":186,"country":57,"cosmosGeoPoint":187,"geoPoint":191,"contacts":31},"Richmond","Virginia","23298",{"type":59,"coordinates":188},[189,190],-77.46026,37.55376,{"lat":190,"lon":189},{"facility":52,"status":53,"city":193,"state":31,"zip":194,"country":195,"cosmosGeoPoint":196,"geoPoint":200,"contacts":31},"Milan","20132","Italy",{"type":59,"coordinates":197},[198,199],12.59836,42.78235,{"lat":199,"lon":198},{"facility":52,"status":53,"city":202,"state":31,"zip":203,"country":195,"cosmosGeoPoint":204,"geoPoint":208,"contacts":31},"Rozzano","20089",{"type":59,"coordinates":205},[206,207],9.1559,45.38193,{"lat":207,"lon":206},{"facility":52,"status":53,"city":210,"state":31,"zip":211,"country":195,"cosmosGeoPoint":212,"geoPoint":216,"contacts":31},"Verona","37134",{"type":59,"coordinates":213},[214,215],10.9938,45.43854,{"lat":215,"lon":214},{"facility":52,"status":53,"city":218,"state":31,"zip":219,"country":220,"cosmosGeoPoint":221,"geoPoint":225,"contacts":31},"Busan","49241","South Korea",{"type":59,"coordinates":222},[223,224],129.03004,35.10168,{"lat":224,"lon":223},{"facility":52,"status":53,"city":227,"state":31,"zip":228,"country":220,"cosmosGeoPoint":229,"geoPoint":233,"contacts":31},"Seongnam","13496",{"type":59,"coordinates":230},[231,232],127.7548,36.4052,{"lat":232,"lon":231},{"facility":52,"status":53,"city":227,"state":31,"zip":235,"country":220,"cosmosGeoPoint":236,"geoPoint":238,"contacts":31},"13620",{"type":59,"coordinates":237},[231,232],{"lat":232,"lon":231},{"facility":52,"status":53,"city":240,"state":31,"zip":241,"country":220,"cosmosGeoPoint":242,"geoPoint":246,"contacts":31},"Seoul","03722",{"type":59,"coordinates":243},[244,245],126.9784,37.566,{"lat":245,"lon":244},{"type":248,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","100562219",false,"NCT06600321","A Study to Evaluate ALN-BCAT in Patients With Hepatocellular Carcinoma","A Phase 1 Study of ALN-BCAT as Monotherapy and in Combination With Pembrolizumab in Patients With Advanced or Metastatic Hepatocellular Carcinoma","Inclusion Criteria:\n\n* Has HCC confirmed histologically or cytologically, or, for patients with liver cirrhosis, clinically by the American Association for the Study of Liver Diseases (AASLD) criteria\n* Has had at least one line of systemic therapy for unresectable advanced or metastatic disease\n* Has at least one wingless-related integration site (WNT)-pathway activating mutation\n* Child-Pugh class A or B7\n\nExclusion Criteria:\n\n* Has fibrolamellar HCC, sarcomatoid HCC, or mixed cholangio-HCC tumors\n* Has symptomatic extrahepatic disease\n* Has received anti-cancer therapy or investigational drugs ≤3 weeks prior to the first dose of study drug\n\nNote: other protocol defined inclusion \u002F exclusion criteria apply","ALL","18 Years",{"count":258,"type":259},158,"ESTIMATED","INTERVENTIONAL",[262],"PHASE1","The purpose of the dose escalation part of the study is to characterize the safety and tolerability of ALN-BCAT as monotherapy and in combination with pembrolizumab; and to determine the recommended dose(s) for expansion (RDFE) of ALN-BCAT as monotherapy and in combination with pembrolizumab. The purpose of the dose expansion part of the of the study is to evaluate the antitumor activity of ALN-BCAT as monotherapy and in combination with pembrolizumab; to characterize the safety and tolerability of ALN-BCAT as monotherapy and in combination with pembrolizumab.",[265,266],"Advanced Hepatocellular Carcinoma","Metastatic Hepatocellular Carcinoma",[268,33,269,270,271,272,273,274],"Hepatocellular carcinoma (HCC)","CTNNB1","Liver disease","Liver cancer","Liver neoplasms","Carcinoma, hepatocellular","WNT pathway activating","2026-06-16",{"date":277,"type":278},"2026-06-17","ACTUAL",{"date":280,"type":278},"2024-12-30",{"date":282,"type":259},"2027-10-31",{"name":5,"class":6},23]