[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100574825":3},{"organization":4,"outcomesModule":7,"designInfo":98,"detailedDescription":97,"studyPopulation":97,"armGroups":104,"interventions":113,"overallOfficials":97,"centralContacts":126,"locations":132,"responsibleParty":324,"collaborators":97,"id":326,"slug":327,"hasResults":328,"nctId":329,"briefTitle":330,"officialTitle":331,"acronym":332,"eligibilityCriteria":333,"healthyVolunteers":328,"sex":334,"minAge":335,"maxAge":97,"enrollmentInfo":336,"targetDuration":97,"studyType":339,"phases":340,"briefSummary":342,"conditions":343,"keywords":345,"overallStatus":135,"whyStopped":97,"lastUpdateSubmitDate":350,"lastUpdatePostDateStruct":351,"startDateStruct":354,"completionDateStruct":356,"leadSponsor":358,"locationsCount":359},{"fullName":5,"class":6},"Bayer","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":44,"otherOutcomes":97},[9,13,16,18,21,24,27,30,32,35,38,41],{"measure":10,"description":11,"timeFrame":12},"Part 1 (dose escalation): Occurrence and severity of TEAEs","TEAE=Treatment emergent adverse event","up to 60 months after first administration",{"measure":14,"description":15,"timeFrame":12},"Part 1 (dose escalation): Recommended safe and active dose (RSAD)","The RSAD is based on incidence of DLT and preliminary anti-tumor activity (ORR using RECIST 1.1 by Investigator assessment) informed by TITE-CRM.\n\nRSAD=Recommended safe and active dose DLT=Dose limiting toxicity ORR=Objective reponse rate RECIST=Response Evaluation Criteria in Solid Tumors TITE-CRM =Time-to-event continual reassessment method",{"measure":17,"description":11,"timeFrame":12},"Part 2 (dose expansion): Occurrence and severity of TEAEs",{"measure":19,"description":20,"timeFrame":12},"Part 2 (dose expansion): ORR using RECIST 1.1 by investigator assessment","ORR=Objective reponse rate RECIST=Response Evaluation Criteria in Solid Tumors",{"measure":22,"description":23,"timeFrame":12},"Part 2 (dose expansion): DCR using RECIST 1.1 by investigator assessment","DCR=Disease control rate RECIST=Response Evaluation Criteria in Solid Tumors",{"measure":25,"description":26,"timeFrame":12},"Part 2 (dose expansion): DoR using RECIST 1.1 by investigator assessment","DoR=Duration of response RECIST=Response Evaluation Criteria in Solid Tumors",{"measure":28,"description":29,"timeFrame":12},"Part 2 (dose expansion): PFS using RECIST 1.1 by investigator assessment","PFS=Progression free survival RECIST=Response Evaluation Criteria in Solid Tumors",{"measure":31,"description":11,"timeFrame":12},"Parts 3 and 4 (dose expansion in combination): Occurrence and severity of TEAEs",{"measure":33,"description":34,"timeFrame":12},"Parts 3 and 4 (dose expansion in combination): ORR using RECIST 1.1 by investigator assessment","ORR= Objective response rate",{"measure":36,"description":37,"timeFrame":12},"Parts 3 and 4 (dose expansion in combination): DCR using RECIST 1.1 by investigator assessment","DCR=Disease control rate",{"measure":39,"description":40,"timeFrame":12},"Parts 3 and 4 (dose expansion in combination): DoR using RECIST 1.1 by investigator assessment","DoR=Duration of response",{"measure":42,"description":43,"timeFrame":12},"Parts 3 and 4 (dose expansion in combination): PFS using RECIST 1.1 by investigator assessment","PFS=Progression free survivial",[45,48,50,53,55,58,60,64,67,70,74,76,79,82,84,87,89,91,93,95],{"measure":46,"description":47,"timeFrame":12},"Part 1 (dose escalation): Recommended dose level(s) based on occurrence and severity of TEAEs and DLTs, PK, immunogenicity, and preliminary anit-tumor activity (ORR using RECIST 1.1 by Investigator assessment)","TEAE=Treatment emergent adverse event DLT=Dose limiting toxicity PK=Pharmacokinetic ORR=Objective response rate RECIST=Response Evaluation Criteria in Solid Tumors",{"measure":49,"description":47,"timeFrame":12},"Part 1 (dose escalation): Recommended dosing regimen based on occurrence and severity of TEAEs and DLTs, PK, immunogenicity, and preliminary anti-tumor activity (ORR using RECIST 1.1 by Investigator assessment)",{"measure":51,"description":52,"timeFrame":12},"Part 1 (dose escalation): ORR using RECIST 1.1 by investigator assessment","ORR=Objective response rate RECIST=Response Evaluation Criteria in Solid Tumors",{"measure":54,"description":23,"timeFrame":12},"Part 1 (dose escalation): DCR using RECIST 1.1 by investigator assessment",{"measure":56,"description":26,"timeFrame":57},"Part 1 (dose escalation): DoR using RECIST 1.1 by investigator assessment","Up to 60 months after first administration",{"measure":59,"description":29,"timeFrame":12},"Part 1 (dose escalation): PFS using RECIST 1.1 by investigator assessment",{"measure":61,"description":62,"timeFrame":63},"Part 1 (dose escalation): Cmax of BAY 3547926 after a single dose and after multiple doses","Cmax=Maximal blood concentration","up to 36 weeks after first administration",{"measure":65,"description":66,"timeFrame":63},"Part 1 (dose escalation): AUC of BAY 3547926 after a single dose and after multiple doses","AUC=Area under the blood concentration versus time curve",{"measure":68,"description":69,"timeFrame":63},"Part 1 (dose escalation): Clearance of BAY 3547926 after a single dose and after multiple doses if data allow","PK=Pharmacokinetic",{"measure":71,"description":72,"timeFrame":73},"Part 2 (dose expansion): Recommended dose based on safety, PK, IG and markers of pharmacodynamic activity and efficacy assessments","PK=Pharmacokinetic IG=Immunogenicity","up to 36 months after first administration",{"measure":75,"description":72,"timeFrame":73},"Part 2 (dose expansion): Recommended schedule based on safety, PK, IG and markers of pharmacodynamic activity and efficacy assessments",{"measure":77,"description":78,"timeFrame":63},"Part 2 (dose expansion): Cmax of BAY 3547926 after a single dose and after multiple doses","Cmax=maximal blood concentration",{"measure":80,"description":81,"timeFrame":63},"Part 2 (dose expansion): AUC of BAY 3547926 after a single dose and after multiple doses","AUC=Area under curve of blood concentration versus time curve",{"measure":83,"description":69,"timeFrame":63},"Part 2 (dose expansion): Clearance of BAY 3547926 after single dose and after multiple doses, where applicable and if data allow",{"measure":85,"description":86,"timeFrame":12},"Parts 3 and 4 (dose expansion in combination): Recommended dose level(s) of BAY 3547926 based on clinical data including, but not limited to, occurrence and severity of TEAEs and DLTs, PK and IG","TEAE=Treatment emergent adverse event DLT=Dose limiting toxicity PK=Pharmacokinetic IG=Immunogenicity",{"measure":88,"description":86,"timeFrame":12},"Parts 3 and 4 (dose expansion in combination): Recommended dosing regimen of BAY 3547926 based on clinical data including, but not limited to, occurrence and severity of TEAEs and DLTs, PK and IG",{"measure":90,"description":86,"timeFrame":12},"Parts 3 and 4 (dose expansion in combination): Recommended schedule of BAY 3547926 based on severity of TEAEs, PK, IG",{"measure":92,"description":78,"timeFrame":12},"Parts 3 and 4 (dose expansion in combination): Cmax of BAY 3547926 after a single dose and after multiple doses of BAY 3547926 in combination",{"measure":94,"description":81,"timeFrame":12},"Parts 3 and 4 (dose expansion in combination): AUC of BAY 3547926 after single dose and after multiple doses of BAY 3547926 in combination",{"measure":96,"description":69,"timeFrame":12},"Parts 3 and 4 (dose expansion in combination): Clearance of BAY 3547926 after single dose and after multiple doses of BAY 3547926 in combination, where applicable and if data allow",null,{"allocation":99,"interventionModel":100,"interventionModelDescription":97,"primaryPurpose":101,"observationalModel":97,"timePerspective":97,"maskingInfo":102},"NA","SINGLE_GROUP","OTHER",{"masking":103,"maskingDescription":97,"whoMasked":97},"NONE",[105],{"label":106,"type":107,"description":108,"interventionNames":109},"BAY 3547926","EXPERIMENTAL","actinium-225 labeled antibody conjugate",[110,111,112],"Drug: BAY 3547926","Drug: BAY 3547922","Drug: BAY 3713391",[114,118,122],{"type":115,"name":106,"description":116,"armGroupLabels":117,"otherNames":97},"DRUG","antibody conjugate with actinium-225 label",[106],{"type":115,"name":119,"description":120,"armGroupLabels":121,"otherNames":97},"BAY 3547922","antibody conjugate without actinium-225 label as preinjection",[106],{"type":115,"name":123,"description":124,"armGroupLabels":125,"otherNames":97},"BAY 3713391","Radioactive imaging agent - optional preinjection",[106],[127],{"name":128,"role":129,"phone":130,"phoneExt":97,"email":131},"Bayer Clinical Trials Contact","CONTACT","(+)1-888-84 22937","clinical-trials-contact@bayer.com",[133,150,159,170,179,188,199,208,213,221,233,244,253,264,275,283,290,301,306,315],{"facility":134,"status":135,"city":134,"state":136,"zip":137,"country":138,"countryCode":139,"cosmosGeoPoint":140,"geoPoint":145,"contacts":146},"Dothan","RECRUITING","Alabama","36303","United States","US",{"type":141,"coordinates":142},"Point",[143,144],-85.39049,31.22323,{"lat":144,"lon":143},[147],{"name":97,"role":129,"phone":97,"phoneExt":148,"email":149},"+13347929500","jlove@alocentclinical.com",{"facility":151,"status":135,"city":151,"state":152,"zip":153,"country":138,"countryCode":139,"cosmosGeoPoint":154,"geoPoint":158,"contacts":97},"Duarte","California","91010",{"type":141,"coordinates":155},[156,157],-117.97729,34.13945,{"lat":157,"lon":156},{"facility":160,"status":135,"city":160,"state":161,"zip":162,"country":163,"countryCode":164,"cosmosGeoPoint":165,"geoPoint":169,"contacts":97},"Edegem","Antwerp","2650","Belgium","BE",{"type":141,"coordinates":166},[167,168],4.44504,51.15662,{"lat":168,"lon":167},{"facility":171,"status":135,"city":171,"state":172,"zip":173,"country":163,"countryCode":164,"cosmosGeoPoint":174,"geoPoint":178,"contacts":97},"Leuven","Flemish Brabant","3000",{"type":141,"coordinates":175},[176,177],4.70093,50.87959,{"lat":177,"lon":176},{"facility":180,"status":135,"city":180,"state":181,"zip":182,"country":163,"countryCode":164,"cosmosGeoPoint":183,"geoPoint":187,"contacts":97},"Kortrijk","West Flanders","8500",{"type":141,"coordinates":184},[185,186],3.26487,50.82803,{"lat":186,"lon":185},{"facility":189,"status":135,"city":189,"state":190,"zip":191,"country":192,"countryCode":193,"cosmosGeoPoint":194,"geoPoint":198,"contacts":97},"Toronto","Ontario","M5G 2C4","Canada","CA",{"type":141,"coordinates":195},[196,197],-79.39864,43.70643,{"lat":197,"lon":196},{"facility":200,"status":135,"city":200,"state":201,"zip":202,"country":192,"countryCode":193,"cosmosGeoPoint":203,"geoPoint":207,"contacts":97},"Montreal","Quebec","H2X 0C1",{"type":141,"coordinates":204},[205,206],-73.58781,45.50884,{"lat":206,"lon":205},{"facility":200,"status":135,"city":200,"state":201,"zip":209,"country":192,"countryCode":193,"cosmosGeoPoint":210,"geoPoint":212,"contacts":97},"H4A 3J1",{"type":141,"coordinates":211},[205,206],{"lat":206,"lon":205},{"facility":214,"status":135,"city":214,"state":201,"zip":215,"country":192,"countryCode":193,"cosmosGeoPoint":216,"geoPoint":220,"contacts":97},"Sherbrooke","J1H 5N4",{"type":141,"coordinates":217},[218,219],-71.89908,45.40008,{"lat":219,"lon":218},{"facility":222,"status":135,"city":223,"state":224,"zip":225,"country":226,"countryCode":227,"cosmosGeoPoint":228,"geoPoint":232,"contacts":97},"Xuhui District","Xuhui","Shanghai Municipality","200032","China","CN",{"type":141,"coordinates":229},[230,231],121.44709,31.19594,{"lat":231,"lon":230},{"facility":234,"status":135,"city":234,"state":235,"zip":236,"country":237,"countryCode":238,"cosmosGeoPoint":239,"geoPoint":243,"contacts":97},"Tampere","Pirkanmaa","33520","Finland","FI",{"type":141,"coordinates":240},[241,242],23.78712,61.49911,{"lat":242,"lon":241},{"facility":245,"status":135,"city":245,"state":246,"zip":247,"country":237,"countryCode":238,"cosmosGeoPoint":248,"geoPoint":252,"contacts":97},"Turku","Southwest Finland","20540",{"type":141,"coordinates":249},[250,251],22.26869,60.45148,{"lat":251,"lon":250},{"facility":254,"status":135,"city":254,"state":255,"zip":256,"country":257,"countryCode":258,"cosmosGeoPoint":259,"geoPoint":263,"contacts":97},"Montpellier","Occitanie","34298","France","FR",{"type":141,"coordinates":260},[261,262],3.87635,43.61093,{"lat":262,"lon":261},{"facility":265,"status":135,"city":265,"state":266,"zip":267,"country":268,"countryCode":269,"cosmosGeoPoint":270,"geoPoint":274,"contacts":97},"L'Hospitalet de Llobregat","Barcelona","08908","Spain","ES",{"type":141,"coordinates":271},[272,273],2.10028,41.35967,{"lat":273,"lon":272},{"facility":276,"status":135,"city":276,"state":97,"zip":277,"country":268,"countryCode":269,"cosmosGeoPoint":278,"geoPoint":282,"contacts":97},"Madrid","28050",{"type":141,"coordinates":279},[280,281],-3.70256,40.4165,{"lat":281,"lon":280},{"facility":284,"status":135,"city":284,"state":97,"zip":97,"country":268,"countryCode":269,"cosmosGeoPoint":285,"geoPoint":289,"contacts":97},"Pamplona",{"type":141,"coordinates":286},[287,288],-1.64323,42.81687,{"lat":288,"lon":287},{"facility":291,"status":135,"city":291,"state":292,"zip":293,"country":294,"countryCode":295,"cosmosGeoPoint":296,"geoPoint":300,"contacts":97},"London","Greater London","NW3 2QG","United Kingdom","UK",{"type":141,"coordinates":297},[298,299],-0.12574,51.50853,{"lat":299,"lon":298},{"facility":291,"status":135,"city":291,"state":292,"zip":302,"country":294,"countryCode":295,"cosmosGeoPoint":303,"geoPoint":305,"contacts":97},"W12 0HS",{"type":141,"coordinates":304},[298,299],{"lat":299,"lon":298},{"facility":307,"status":135,"city":307,"state":308,"zip":309,"country":294,"countryCode":295,"cosmosGeoPoint":310,"geoPoint":314,"contacts":97},"Glasgow","Scotland","G12 0YN",{"type":141,"coordinates":311},[312,313],-4.25763,55.86515,{"lat":313,"lon":312},{"facility":316,"status":135,"city":316,"state":317,"zip":318,"country":294,"countryCode":295,"cosmosGeoPoint":319,"geoPoint":323,"contacts":97},"Sutton","Surrey","SM2 5PT",{"type":141,"coordinates":320},[321,322],-0.2,51.35,{"lat":322,"lon":321},{"type":325,"investigatorFullName":97,"investigatorTitle":97,"investigatorAffiliation":97,"oldNameTitle":97,"oldOrganization":97},"SPONSOR","100574825","phase-1-a-first-in-human-study-to-learn-about-the-safety-of-bay-3547926-and-how-well-it-works-in-participants-with-advanced-liver-cancer-100574825",false,"NCT06764316","A First-in-human Study to Learn About the Safety of BAY 3547926 and How Well it Works in Participants With Advanced Liver Cancer","A Multicenter, Open Label, Non-randomized First-in-human Phase 1 Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of BAY 3547926 Alone, and in Combination, in Participants With Advanced Hepatocellular Carcinoma (HCC)","BANTAM-01","Inclusion Criteria:\n\n* Locally advanced or metastatic and\u002For unresectable HCC (hepatocellular carcinoma) with histological or cytological confirmation, or non-invasive diagnosis as per American Association for the Study of Liver Diseases (AASLD) criteria in participants with a confirmed diagnosis of cirrhosis.\n* Demonstrated positive centrally confirmed GPC3 expression by immunohistochemistry (IHC) on tumor sample.\n* Disease not amenable to, or progressive disease after, curative surgery and\u002For locoregional therapies of established efficacy such as resection, local ablation, chemoembolization.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1.\n* At least one measurable lesion by computed tomography (CT) scan or magnetic resonance imaging (MRI) according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.1. as assessed by local site Investigator within 28 days prior to the start of the study treatment.\n* Adequate bone marrow and organ function\n\nExclusion Criteria:\n\n* Fibrolamellar HCC, sarcomatoid HCC, and mixed hepatocellular\u002Fcholangiocarcinoma subtypes.\n* Participants with a history or clinical evidence of CNS metastases, unless they meet specific criteria\n* History of encephalopathy ≥ Grade 2 within the past 12 months\n* Clinically significant ascites","ALL","18 Years",{"count":337,"type":338},148,"ESTIMATED","INTERVENTIONAL",[341],"PHASE1","In this study, researchers want to learn about the safety of a new drug, BAY 3547926, and how well the drug works in people with a type of liver cancer called advanced hepatocellular carcinoma (HCC), which has a special protein called Glypican 3 (GPC3). Researchers want to find the best dose of BAY 3547926 for people with advanced HCC and look at the way the body absorbs and distributes the drug.\n\nThe study drug, BAY 3547926, delivers a radioactive agent to cancer cells. The radioactive agent emits radiations which can damage the cancer cells and cause them to die. These radiations travel a small distance, so are expected to cause little damage to surrounding healthy tissues. This is the first study of BAY 3547926 in humans.\n\nParticipants will take part in one of the 4 different parts of the study. In Part 1, participants will receive different doses of BAY 3547926 alone to find the dose that is deemed safe and works best for the participants. When this dose has been found, a larger number of participants will receive BAY 3547926 alone in Part 2 or with other treatments in Parts 3 and 4 of the study.\n\nDuring the study, the doctors and their study team will do health check-ups, take pictures (scans) of the body, collect blood and urine samples, and ask participants questions about how they are feeling and what health problems they are having.",[344],"Hepatocellular Carcinoma",[346,347,348,349],"Hepatocellular carcinoma (HCC)","Locally advanced HCC","Metastatic HCC","Unresectable HCC","2026-06-29",{"date":352,"type":353},"2026-06-30","ACTUAL",{"date":355,"type":353},"2025-02-28",{"date":357,"type":338},"2031-08-31",{"name":5,"class":6},20]