[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100527382":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":22,"centralContacts":31,"locations":37,"responsibleParty":179,"collaborators":22,"id":181,"slug":182,"hasResults":183,"nctId":184,"briefTitle":185,"officialTitle":186,"acronym":22,"eligibilityCriteria":187,"healthyVolunteers":183,"sex":188,"minAge":189,"maxAge":190,"enrollmentInfo":191,"targetDuration":22,"studyType":194,"phases":195,"briefSummary":197,"conditions":198,"keywords":206,"overallStatus":53,"whyStopped":22,"lastUpdateSubmitDate":240,"lastUpdatePostDateStruct":241,"startDateStruct":244,"completionDateStruct":246,"leadSponsor":248,"locationsCount":249},{"fullName":5,"class":6},"AstraZeneca","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Dose Exploration and Dose Escalation","EXPERIMENTAL","The study conducted in two parts: Part A Dose Exploration and Part B Dose Escalation\n\nFPI-2053 dose exploration to determine the optimal pre-dose administration of FPI-2053 with a fixed dose of \\[225Ac\\]-FPI-2068.\n\n\\[225Ac\\]-FPI-2068 dose escalation with the optimal dose of FPI-2053 as determined in Part A.",[13,14,15],"Drug: FPI-2053","Drug: [111In]-FPI-2107","Drug: [225Ac]-FPI-2068",[17,23,27],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":22},"DRUG","FPI-2053","FPI-2053 is a bispecific antibody that targets EGFR and cMET",[9],null,{"type":18,"name":24,"description":25,"armGroupLabels":26,"otherNames":22},"[111In]-FPI-2107","\\[111In\\]-FPI-2107 is an imaging agent in which indium-111 is conjugated to FPI-2053.\n\nParticipants will have a fixed dose of \\[111In\\]-FPI-2107 followed by imaging scans (with or without pre-administration of FPI-2053).",[9],{"type":18,"name":28,"description":29,"armGroupLabels":30,"otherNames":22},"[225Ac]-FPI-2068","\\[225Ac\\]-FPI-2068 is a radiopharmaceutical therapy in which an alpha emitter, actinium-225, is conjugated to FPI-2053.\n\nParticipants will be dosed through IV administration every 56 days for up to 3 cycles of the Treatment Period.",[9],[32],{"name":33,"role":34,"phone":35,"phoneExt":22,"email":36},"AstraZeneca Clinical Study Information Center","CONTACT","1-877-240-9479","information.center@astrazeneca.com",[38,52,61,70,79,88,97,106,115,124,133,142,153,162,171],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":22},"Research Site","WITHDRAWN","Irvine","California","92618","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-117.82311,33.66946,{"lat":50,"lon":49},{"facility":39,"status":53,"city":54,"state":42,"zip":55,"country":44,"countryCode":45,"cosmosGeoPoint":56,"geoPoint":60,"contacts":22},"RECRUITING","Palo 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1Z2","Canada","CA",{"type":47,"coordinates":149},[150,151],-113.46871,53.55014,{"lat":151,"lon":150},{"facility":39,"status":53,"city":154,"state":155,"zip":156,"country":146,"countryCode":147,"cosmosGeoPoint":157,"geoPoint":161,"contacts":22},"Halifax","Nova Scotia","B3H 2Y9",{"type":47,"coordinates":158},[159,160],-63.57688,44.64269,{"lat":160,"lon":159},{"facility":39,"status":53,"city":163,"state":164,"zip":165,"country":146,"countryCode":147,"cosmosGeoPoint":166,"geoPoint":170,"contacts":22},"Montreal","Quebec","H2X 0A9",{"type":47,"coordinates":167},[168,169],-73.58781,45.50884,{"lat":169,"lon":168},{"facility":39,"status":53,"city":172,"state":164,"zip":173,"country":146,"countryCode":147,"cosmosGeoPoint":174,"geoPoint":178,"contacts":22},"Sherbrooke","J1H 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as defined by RECIST Version 1.1\n\nECOG Performance status of 0 or 1\n\nAdequate organ function\n\nKey Exclusion Criteria:\n\nPrevious treatment with any systemic radiopharmaceutical\n\nPrior anti-cancer therapy unless adequate washout and recovery from toxicities\n\nContraindications to or inability to perform the imaging procedures required in this study\n\nRadiation therapy (RT) within 28 days prior to the first dose of \\[111In\\]-FPI-2107\n\nUncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (≥ once per month)\n\nPatients with known CNS metastatic disease unless treated and stable","ALL","18 Years","130 Years",{"count":192,"type":193},70,"ESTIMATED","INTERVENTIONAL",[196],"PHASE1","This is a first-in-human, Phase 1, non-randomized, multicenter, open-label clinical study designed to investigate the safety, tolerability, dosimetry, biodistribution, and pharmacokinetics (PK) of \\[225Ac\\]-FPI-2068, \\[111In\\]-FPI-2107, and FPI-2053 in metastatic and\u002For recurrent solid tumors (HNSCC, NSCLC, mCRC, PDAC, GC, RCC).",[199,200,201,202,203,204,205],"Advanced Solid Tumor","Metastatic Colorectal Carcinoma","Head and Neck Squamous Cell Carcinoma","Non-small Cell Lung Cancer","Pancreatic Ductal Adenocarcinoma","Gastric Cancer","Renal Cell Carcinoma",[207,208,19,209,210,211,212,213,214,215,216,217,218,219,220,221,222,223,224,225,226,227,228,229,230,231,232,233,234,235,236,237,238,239],"FPI-2068","FPI-2107","Actinium-225","225Ac","Indium-111","111In","Solid tumors","Targeted alpha therapy","TAT","Epidermal growth factor receptor","EGFR","Mesenchymal-epithelial transition factor","cMET","Bispecific antibody","Radioimmuno-SPECT agent","Radioimmuno-therapeutic agent","Monoclonal antibody","Bifunctional chelating agent","Radiopharmaceutical therapy","Alpha particle emitter","Directed bispecific monovalent antibody","bsAb","Bifunctional chelate","mCRC","HNSCC","NSCLC","PDAC","GC","RCC","RLT","Radioligand Therapy","EGFRm","EGFRwt","2026-05-22",{"date":242,"type":243},"2026-05-26","ACTUAL",{"date":245,"type":243},"2024-07-31",{"date":247,"type":193},"2028-05-12",{"name":5,"class":6},15]