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270223","Liège","4000",{"type":77,"coordinates":177},[178,179],5.56749,50.63373,{"lat":179,"lon":178},{"facility":182,"status":70,"city":183,"state":184,"zip":185,"country":186,"countryCode":187,"cosmosGeoPoint":188,"geoPoint":192,"contacts":48},"Princess Margaret Cancer Centre \u002FID# 268277","Toronto","Ontario","M5G 2M9","Canada","CA",{"type":77,"coordinates":189},[190,191],-79.39864,43.70643,{"lat":191,"lon":190},{"facility":194,"status":70,"city":195,"state":196,"zip":197,"country":186,"countryCode":187,"cosmosGeoPoint":198,"geoPoint":202,"contacts":48},"Centre Hospitalier de l'Universite de Montreal (CHUM) \u002FID# 268763","Montreal","Quebec","H2X 0C1",{"type":77,"coordinates":199},[200,201],-73.58781,45.50884,{"lat":201,"lon":200},{"facility":204,"status":70,"city":195,"state":196,"zip":205,"country":186,"countryCode":187,"cosmosGeoPoint":206,"geoPoint":208,"contacts":48},"Jewish General Hospital \u002FID# 268413","H3T 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268452","Harbin","Heilongjiang","150081",{"type":77,"coordinates":237},[238,239],126.65,45.75,{"lat":239,"lon":238},{"facility":242,"status":70,"city":243,"state":244,"zip":245,"country":214,"countryCode":215,"cosmosGeoPoint":246,"geoPoint":250,"contacts":48},"Union Hospital - Tongji Medical College \u002FID# 268796","Wuhan","Hubei","430022",{"type":77,"coordinates":247},[248,249],114.26667,30.58333,{"lat":249,"lon":248},{"facility":252,"status":70,"city":253,"state":254,"zip":255,"country":214,"countryCode":215,"cosmosGeoPoint":256,"geoPoint":260,"contacts":48},"The first Affiliated Hospital, Zhejiang University School of Medicine. \u002FID# 268782","Hangzhou","Zhejiang","310003",{"type":77,"coordinates":257},[258,259],120.16142,30.29365,{"lat":259,"lon":258},{"facility":262,"status":70,"city":263,"state":264,"zip":265,"country":266,"countryCode":267,"cosmosGeoPoint":268,"geoPoint":272,"contacts":48},"Universitaetsklinikum Freiburg \u002FID# 270407","Freiburg im 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270432","Leipzig","Saxony","04103",{"type":77,"coordinates":299},[300,301],12.37129,51.33962,{"lat":301,"lon":300},{"facility":304,"status":70,"city":305,"state":48,"zip":306,"country":266,"countryCode":267,"cosmosGeoPoint":307,"geoPoint":311,"contacts":48},"Haematologisch-Onkologische Praxis Eppendorf \u002FID# 268024","Hamburg","20249",{"type":77,"coordinates":308},[309,310],9.99302,53.55073,{"lat":310,"lon":309},{"facility":313,"status":70,"city":314,"state":315,"zip":316,"country":317,"countryCode":318,"cosmosGeoPoint":319,"geoPoint":323,"contacts":48},"Meir Medical Center \u002FID# 267998","Kfar Saba","Central District","4428164","Israel","IL",{"type":77,"coordinates":320},[321,322],34.90694,32.175,{"lat":322,"lon":321},{"facility":325,"status":70,"city":326,"state":327,"zip":328,"country":317,"countryCode":318,"cosmosGeoPoint":329,"geoPoint":333,"contacts":48},"Soroka Medical Center \u002FID# 268301","Beersheba","Southern District","8410101",{"type":77,"coordinates":330},[331,332],34.7913,31.25181,{"lat":332,"lon":331},{"facility":335,"status":70,"city":336,"state":336,"zip":337,"country":317,"countryCode":318,"cosmosGeoPoint":338,"geoPoint":342,"contacts":48},"Tel Aviv Sourasky Medical Center \u002FID# 267755","Tel Aviv","6423906",{"type":77,"coordinates":339},[340,341],34.78057,32.08088,{"lat":341,"lon":340},{"facility":344,"status":70,"city":345,"state":48,"zip":346,"country":317,"countryCode":318,"cosmosGeoPoint":347,"geoPoint":351,"contacts":48},"Shaare Zedek Medical Center \u002FID# 267752","Jerusalem","9103102",{"type":77,"coordinates":348},[349,350],35.21633,31.76904,{"lat":350,"lon":349},{"facility":353,"status":70,"city":345,"state":48,"zip":354,"country":317,"countryCode":318,"cosmosGeoPoint":355,"geoPoint":357,"contacts":48},"Hadassah Medical Center-Hebrew University \u002FID# 267753","91120",{"type":77,"coordinates":356},[349,350],{"lat":350,"lon":349},{"facility":359,"status":70,"city":360,"state":361,"zip":362,"country":363,"countryCode":364,"cosmosGeoPoint":365,"geoPoint":369,"contacts":48},"Aichi Cancer Center \u002FID# 268124","Nagoya","Aichi-ken","464-8681","Japan","JP",{"type":77,"coordinates":366},[367,368],136.90641,35.18147,{"lat":368,"lon":367},{"facility":371,"status":70,"city":372,"state":373,"zip":374,"country":363,"countryCode":364,"cosmosGeoPoint":48,"geoPoint":48,"contacts":48},"National Cancer Center Hospital East \u002FID# 268083","Kashiwa-shi","Chiba","277-8577",{"facility":376,"status":70,"city":377,"state":378,"zip":379,"country":363,"countryCode":364,"cosmosGeoPoint":48,"geoPoint":48,"contacts":48},"Shizuoka Cancer Center \u002FID# 268123","Sunto-gun","Shizuoka","411-8777",{"facility":381,"status":70,"city":382,"state":383,"zip":384,"country":363,"countryCode":364,"cosmosGeoPoint":48,"geoPoint":48,"contacts":48},"National Cancer Center Hospital \u002FID# 268648","Chuo-Ku","Tokyo","104-0045",{"facility":386,"status":70,"city":387,"state":383,"zip":388,"country":363,"countryCode":364,"cosmosGeoPoint":48,"geoPoint":48,"contacts":48},"The Cancer Institute Hospital Of JFCR \u002FID# 268656","Koto-ku","135-8550",{"facility":390,"status":70,"city":391,"state":48,"zip":392,"country":393,"countryCode":394,"cosmosGeoPoint":395,"geoPoint":399,"contacts":48},"Pan American Center for Oncology Trials \u002FID# 268833","Rio Piedras","00935","Puerto Rico","PR",{"type":77,"coordinates":396},[397,398],-66.04989,18.39745,{"lat":398,"lon":397},{"facility":401,"status":70,"city":402,"state":403,"zip":404,"country":405,"countryCode":406,"cosmosGeoPoint":407,"geoPoint":411,"contacts":48},"Hospital Universitario de Navarra \u002FID# 270119","Pamplona","Navarre","31008","Spain","ES",{"type":77,"coordinates":408},[409,410],-1.64323,42.81687,{"lat":410,"lon":409},{"facility":413,"status":70,"city":414,"state":48,"zip":415,"country":405,"countryCode":406,"cosmosGeoPoint":416,"geoPoint":420,"contacts":48},"Hospital General Universitario Gregorio Maranon \u002FID# 270037","Madrid","28007",{"type":77,"coordinates":417},[418,419],-3.70256,40.4165,{"lat":419,"lon":418},{"facility":422,"status":70,"city":423,"state":48,"zip":424,"country":405,"countryCode":406,"cosmosGeoPoint":425,"geoPoint":429,"contacts":48},"Complexo Hospitalario Universitario de Ourense \u002FID# 270042","Ourense","32005",{"type":77,"coordinates":426},[427,428],-7.86407,42.33669,{"lat":428,"lon":427},{"facility":431,"status":70,"city":432,"state":48,"zip":433,"country":405,"countryCode":406,"cosmosGeoPoint":434,"geoPoint":438,"contacts":48},"Hospital Clinico Universitario de Valencia \u002FID# 270040","Valencia","46010",{"type":77,"coordinates":435},[436,437],-0.37966,39.47391,{"lat":437,"lon":436},{"facility":440,"status":70,"city":441,"state":48,"zip":442,"country":443,"countryCode":444,"cosmosGeoPoint":445,"geoPoint":449,"contacts":48},"Kaohsiung Medical University Chung-Ho Memorial Hospital \u002FID# 267672","Kaohsiung City","807","Taiwan","TW",{"type":77,"coordinates":446},[447,448],120.31333,22.61626,{"lat":448,"lon":447},{"facility":451,"status":70,"city":452,"state":48,"zip":453,"country":443,"countryCode":444,"cosmosGeoPoint":454,"geoPoint":458,"contacts":48},"China Medical University Hospital \u002FID# 267667","Taichung","40447",{"type":77,"coordinates":455},[456,457],120.6839,24.1469,{"lat":457,"lon":456},{"facility":460,"status":70,"city":461,"state":48,"zip":462,"country":443,"countryCode":444,"cosmosGeoPoint":463,"geoPoint":467,"contacts":48},"National Cheng Kung University Hospital \u002FID# 267669","Tainan","704",{"type":77,"coordinates":464},[465,466],120.21333,22.99083,{"lat":466,"lon":465},{"facility":469,"status":70,"city":470,"state":48,"zip":471,"country":443,"countryCode":444,"cosmosGeoPoint":472,"geoPoint":476,"contacts":48},"National Taiwan University Hospital \u002FID# 267666","Taipei","100",{"type":77,"coordinates":473},[474,475],121.52639,25.05306,{"lat":475,"lon":474},{"facility":478,"status":70,"city":470,"state":48,"zip":479,"country":443,"countryCode":444,"cosmosGeoPoint":480,"geoPoint":482,"contacts":48},"Taipei Veterans General Hospital \u002FID# 267664","112",{"type":77,"coordinates":481},[474,475],{"lat":475,"lon":474},{"facility":484,"status":70,"city":485,"state":48,"zip":486,"country":443,"countryCode":444,"cosmosGeoPoint":487,"geoPoint":491,"contacts":48},"Linkou Chang Gung Memorial Hospital \u002FID# 267668","Taoyuan City","333",{"type":77,"coordinates":488},[489,490],121.29696,24.99368,{"lat":490,"lon":489},{"facility":493,"status":70,"city":494,"state":495,"zip":496,"country":497,"countryCode":498,"cosmosGeoPoint":499,"geoPoint":503,"contacts":48},"Barts Health NHS Trust \u002FID# 270796","London","Greater London","E1 2ES","United Kingdom","UK",{"type":77,"coordinates":500},[501,502],-0.12574,51.50853,{"lat":502,"lon":501},{"facility":505,"status":70,"city":506,"state":507,"zip":508,"country":497,"countryCode":498,"cosmosGeoPoint":509,"geoPoint":513,"contacts":48},"Oxford University Hospital NHS Trust \u002FID# 274614","Oxford","Oxfordshire","OX3 7LE",{"type":77,"coordinates":510},[511,512],-1.25596,51.75222,{"lat":512,"lon":511},{"facility":515,"status":70,"city":516,"state":48,"zip":517,"country":497,"countryCode":498,"cosmosGeoPoint":518,"geoPoint":522,"contacts":48},"Queen Elizabeth Hospital Birmingham \u002FID# 271199","Birmingham","B15 2TH",{"type":77,"coordinates":519},[520,521],-1.89983,52.48142,{"lat":521,"lon":520},{"facility":524,"status":70,"city":525,"state":48,"zip":526,"country":497,"countryCode":498,"cosmosGeoPoint":527,"geoPoint":531,"contacts":48},"NHS Tayside Health Board \u002FID# 270799","Dundee","DD2 1SG",{"type":77,"coordinates":528},[529,530],-2.97489,56.46913,{"lat":530,"lon":529},{"type":533,"investigatorFullName":48,"investigatorTitle":48,"investigatorAffiliation":48,"oldNameTitle":48,"oldOrganization":48},"SPONSOR","100564371","phase-2-a-study-to-evaluate-the-adverse-events-efficacy-and-optimal-dose-of-intravenous-iv-abbv-400-in-combination-with-iv-fluorouracil-leucovorin-and-budigalimab-in-adult-participants-with-locally-advanced-unresectable-or-metastatic-gastric-gastroesophageal-junction-or-esophageal-adenocarcinoma-100564371",false,"NCT06628310","A Study to Evaluate the Adverse Events, Efficacy, and Optimal Dose of Intravenous (IV) ABBV-400 in Combination With IV Fluorouracil, Leucovorin, and Budigalimab in Adult Participants With Locally Advanced Unresectable or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma","A Phase 2 Randomized Study to Evaluate the Safety, Efficacy, and Optimal Dose of Telisotuzumab Adizutecan in Combination With Fluorouracil, Leucovorin, and Budigalimab as First-Line Treatment in Subjects With Locally Advanced Unresectable or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma (AndroMETa-GEA-977)","AndroMETa-GEA","Inclusion Criteria:\n\n* Have inoperable, advanced or metastatic histologically- or cytologically confirmed gastric, gastroesophageal junction, or esophageal adenocarcinoma.\n* Have measurable disease determined using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.\n* Human epidermal growth factor receptor 2 (HER2) negative disease, defined as immunohistochemistry (IHC) (0, or 1+) or fluorescence in situ hybridization (FISH) negative.\n* Known programmed death ligand 1 (PD-L1) status at screening, or availability of tumor tissue for central PD-L1 testing prior to enrollment.\n\nExclusion Criteria:\n\n* Have prior systemic therapy in the locally advanced, unresectable, or metastatic setting.\n* History of clinically significant, intercurrent lung-specific illnesses including, but not limited to those listed in the protocol.","ALL","18 Years",{"count":545,"type":546},180,"ESTIMATED","INTERVENTIONAL",[549],"PHASE2","Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess adverse events and change in disease activity when telisotuzumab adizutecan (ABBV-400) is given in combination with Fluorouracil, Leucovorin, and a programmed cell death receptor 1 (PD1) inhibitor Budigalimab. The combination (AFLB) will be given to adult participants to treat locally advanced unresectable or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma (mGEA).\n\nTelisotuzumab Adizutecan (ABBV-400) and Budigalimab are investigational drugs being developed for the treatment of mGEA. Fluorouracil and Leucovorin are drugs approved for the treatment of mGEA. This study will be divided into two stages, with the first stage treating participants with increasing doses of ABBV-400 within the AFLB regimen until the dose reached is tolerable and expected to be efficacious. Participants will then be randomized into groups called treatment arms where one group will receive Budigalimab and FOLFOX (Fluorouracil, Leucovorin, and Oxaliplatin) . A further two treatment groups will receive AFLB, but with two optimized doses of ABBV-400 to allow for the best dose to be studied in the future. Approximately 180 adult participants with mGEA will be enrolled in the study in 51 sites worldwide.\n\nIn the dose escalation stage, participants will be treated with increasing intravenous (IV) doses of telisotuzumab adizutecan (ABBV-400) within the AFLB regimen until the dose reached is tolerable and expected to be efficacious. In the dose optimization stage, participants will receive FOLFOX or receive AFLB, but with one of two optimized doses of ABBV-400. The study will run for a duration of approximately 6 years.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.",[552,553,554],"Locally Advanced Unresectable or Metastatic Gastric Adenocarcinoma","Gastroesophageal Junction Adenocarcinoma","Esophageal Adenocarcinoma",[552,553,554,37,43,39,33],"2026-03-26",{"date":558,"type":559},"2026-03-30","ACTUAL",{"date":561,"type":559},"2024-12-13",{"date":563,"type":546},"2030-10",{"name":5,"class":6},49]