[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100429974":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":26,"responsibleParty":257,"collaborators":19,"id":259,"slug":260,"hasResults":261,"nctId":262,"briefTitle":263,"officialTitle":264,"acronym":19,"eligibilityCriteria":265,"healthyVolunteers":261,"sex":266,"minAge":267,"maxAge":19,"enrollmentInfo":268,"targetDuration":19,"studyType":271,"phases":272,"briefSummary":275,"conditions":276,"keywords":19,"overallStatus":29,"whyStopped":19,"lastUpdateSubmitDate":279,"lastUpdatePostDateStruct":280,"startDateStruct":283,"completionDateStruct":285,"leadSponsor":287,"locationsCount":288},{"fullName":5,"class":6},"Heidelberg Pharma AG","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"HDP-101","EXPERIMENTAL","Participants will receive HDP-101 intravenously in a 21 day cycle until disease progression, intolerable toxicity, Investigator's discretion or patient withdrawal.\n\nDuring the phase 1 tolerability of different dose levels will be evaluated. During the phase 2a dose expansion part the recommended phase 2 dose (RP2D) of HDP-101 will be administered.",[13],"Drug: HDP-101",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","HDP-101 is available as lyophilized white powder for preparation of infusion.",[9],null,[21],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},"Lei Wang, MD","CONTACT","+ 49 6203 1009 0","clinical@hdpharma.com",[27,41,52,62,71,81,93,102,111,120,130,139,148,157,168,174,183,194,203,212,221,230,239,249],{"facility":28,"status":29,"city":30,"state":31,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":19},"Winship Cancer Institute of Emory University","RECRUITING","Atlanta","Georgia","30322","United States","US",{"type":36,"coordinates":37},"Point",[38,39],-84.38798,33.749,{"lat":39,"lon":38},{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":33,"countryCode":34,"cosmosGeoPoint":47,"geoPoint":51,"contacts":19},"Norton Healthcare, Inc.","NOT_YET_RECRUITING","Louisville","Kentucky","40202",{"type":36,"coordinates":48},[49,50],-85.75941,38.25424,{"lat":50,"lon":49},{"facility":53,"status":43,"city":54,"state":55,"zip":56,"country":33,"countryCode":34,"cosmosGeoPoint":57,"geoPoint":61,"contacts":19},"Nebraska Cancer Institute","Omaha","Nebraska","68130",{"type":36,"coordinates":58},[59,60],-95.94043,41.25626,{"lat":60,"lon":59},{"facility":63,"status":29,"city":64,"state":64,"zip":65,"country":33,"countryCode":34,"cosmosGeoPoint":66,"geoPoint":70,"contacts":19},"Mount Sinai, The Tisch Cancer Instutute","New York","10029",{"type":36,"coordinates":67},[68,69],-74.00597,40.71427,{"lat":69,"lon":68},{"facility":72,"status":29,"city":73,"state":74,"zip":75,"country":33,"countryCode":34,"cosmosGeoPoint":76,"geoPoint":80,"contacts":19},"MD Anderson Cancer Center","Houston","Texas","77030",{"type":36,"coordinates":77},[78,79],-95.36327,29.76328,{"lat":79,"lon":78},{"facility":82,"status":83,"city":84,"state":19,"zip":85,"country":86,"countryCode":87,"cosmosGeoPoint":88,"geoPoint":92,"contacts":19},"Charité - Campus Benjamin Franklin Med. 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Innere Medizin III","Chemnitz","09116",{"type":36,"coordinates":98},[99,100],12.92922,50.8357,{"lat":100,"lon":99},{"facility":103,"status":83,"city":104,"state":19,"zip":105,"country":86,"countryCode":87,"cosmosGeoPoint":106,"geoPoint":110,"contacts":19},"Universitätsklinikum Köln","Cologne","50937",{"type":36,"coordinates":107},[108,109],6.95,50.93333,{"lat":109,"lon":108},{"facility":112,"status":83,"city":113,"state":19,"zip":114,"country":86,"countryCode":87,"cosmosGeoPoint":115,"geoPoint":119,"contacts":19},"Asklepios Klinik Altona, Haematologie und internistische Onkologie","Hamburg","22763",{"type":36,"coordinates":116},[117,118],9.99302,53.55073,{"lat":118,"lon":117},{"facility":121,"status":122,"city":123,"state":19,"zip":124,"country":86,"countryCode":87,"cosmosGeoPoint":125,"geoPoint":129,"contacts":19},"Universitätsklinikum Heidelberg","ACTIVE_NOT_RECRUITING","Heidelberg","69120",{"type":36,"coordinates":126},[127,128],8.69079,49.40768,{"lat":128,"lon":127},{"facility":131,"status":83,"city":132,"state":19,"zip":133,"country":86,"countryCode":87,"cosmosGeoPoint":134,"geoPoint":138,"contacts":19},"Universitätsklinikum Schleswig-Holstein","Kiel","24105",{"type":36,"coordinates":135},[136,137],10.13489,54.32133,{"lat":137,"lon":136},{"facility":140,"status":122,"city":141,"state":19,"zip":142,"country":86,"countryCode":87,"cosmosGeoPoint":143,"geoPoint":147,"contacts":19},"UKSH Campus Lübeck Klinik für Hämatologie und Onkologie","Lübeck","23538",{"type":36,"coordinates":144},[145,146],10.68729,53.86893,{"lat":146,"lon":145},{"facility":149,"status":83,"city":150,"state":19,"zip":151,"country":86,"countryCode":87,"cosmosGeoPoint":152,"geoPoint":156,"contacts":19},"Universitätsklinikum Mainz","Mainz","55131",{"type":36,"coordinates":153},[154,155],8.28008,49.98185,{"lat":155,"lon":154},{"facility":158,"status":29,"city":159,"state":19,"zip":160,"country":161,"countryCode":162,"cosmosGeoPoint":163,"geoPoint":167,"contacts":19},"Semmelweis University, Belgyogyaszati es Onkologiai Klinika","Budapest","1083","Hungary","HU",{"type":36,"coordinates":164},[165,166],19.04045,47.49835,{"lat":166,"lon":165},{"facility":169,"status":83,"city":159,"state":19,"zip":170,"country":161,"countryCode":162,"cosmosGeoPoint":171,"geoPoint":173,"contacts":19},"National Institute of Oncology, Department of Oncological Internal Medicine","1122",{"type":36,"coordinates":172},[165,166],{"lat":166,"lon":165},{"facility":175,"status":43,"city":176,"state":19,"zip":177,"country":161,"countryCode":162,"cosmosGeoPoint":178,"geoPoint":182,"contacts":19},"Pécsi Tudományegyetem Klinikai Központ","Pécs","7624",{"type":36,"coordinates":179},[180,181],18.22814,46.07617,{"lat":181,"lon":180},{"facility":184,"status":29,"city":185,"state":19,"zip":186,"country":187,"countryCode":188,"cosmosGeoPoint":189,"geoPoint":193,"contacts":19},"Pratia Onkologia Katowice","Katowice","40-568","Poland","PL",{"type":36,"coordinates":190},[191,192],19.02173,50.2597,{"lat":192,"lon":191},{"facility":195,"status":29,"city":196,"state":19,"zip":197,"country":187,"countryCode":188,"cosmosGeoPoint":198,"geoPoint":202,"contacts":19},"Pratia Onkologia Kraków","Krakow","40-519",{"type":36,"coordinates":199},[200,201],19.93658,50.06143,{"lat":201,"lon":200},{"facility":204,"status":83,"city":205,"state":19,"zip":206,"country":187,"countryCode":188,"cosmosGeoPoint":207,"geoPoint":211,"contacts":19},"Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. 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Kopernika w Lodzi","Lodz","93-513",{"type":36,"coordinates":208},[209,210],19.47395,51.77058,{"lat":210,"lon":209},{"facility":213,"status":83,"city":214,"state":19,"zip":215,"country":187,"countryCode":188,"cosmosGeoPoint":216,"geoPoint":220,"contacts":19},"Szpital Wojewodzki w Opolu","Opole","45-061",{"type":36,"coordinates":217},[218,219],17.92604,50.67119,{"lat":219,"lon":218},{"facility":222,"status":29,"city":223,"state":19,"zip":224,"country":187,"countryCode":188,"cosmosGeoPoint":225,"geoPoint":229,"contacts":19},"AIDPORT Sp. zo.o.","Skórzewo","60-185",{"type":36,"coordinates":226},[227,228],17.81889,53.03629,{"lat":228,"lon":227},{"facility":231,"status":29,"city":232,"state":19,"zip":233,"country":187,"countryCode":188,"cosmosGeoPoint":234,"geoPoint":238,"contacts":19},"MICS Centrum Medyczne Torun","Torun","87-100",{"type":36,"coordinates":235},[236,237],18.59814,53.01375,{"lat":237,"lon":236},{"facility":240,"status":29,"city":241,"state":19,"zip":19,"country":242,"countryCode":243,"cosmosGeoPoint":244,"geoPoint":248,"contacts":19},"Arensia Clinics SRL","Bucharest","Romania","RO",{"type":36,"coordinates":245},[246,247],26.10626,44.43225,{"lat":247,"lon":246},{"facility":250,"status":43,"city":251,"state":19,"zip":19,"country":242,"countryCode":243,"cosmosGeoPoint":252,"geoPoint":256,"contacts":19},"Oncology Institute Prof. Dr. Ion Chiricuta I.O.C.N.","Cluj-Napoca",{"type":36,"coordinates":253},[254,255],23.6,46.76667,{"lat":255,"lon":254},{"type":258,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100429974","phase-1-study-to-assess-safety-of-hdp-101-in-patients-with-relapsed-refractory-multiple-myeloma-100429974",false,"NCT04879043","Study to Assess Safety of HDP-101 in Patients With Relapsed Refractory Multiple Myeloma","A Phase 1\u002F2a, First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of HDP-101 in Patients With Plasma Cell Disorders Including Multiple Myeloma","Inclusion Criteria:\n\n* Male or female aged ≥18 years.\n* Life expectancy \\>12 weeks.\n* Eastern Cooperative Oncology Group Performance Status (PS) of 0 to 2.\n* A confirmed diagnosis of active MM according to the diagnostic criteria established by the International Myeloma Working Group (IMWG).\n* Must have undergone SCT or is considered transplant ineligible.\n* Must have undergone prior treatments with antimyeloma therapy which must have included an immunomodulatory drug, proteasome inhibitor, and anti-CD38 treatment, alone or in combination. In addition, the patient should either refractory or intolerant to any established standard of care therapy providing a meaningful clinical benefit for the patient assessed by the Investigator.\n* Measurable disease as per IMWG criteria.\n* Adequate organ system function as defined in protocol.\n\nExclusion Criteria:\n\n* For patient entering the Phase 2a part only: Prior treatment with any approved or experimental BCMA-targeting modalities are not allowed.\n* Known central nervous system involvement.\n* Plasma cell leukemia.\n* History of congestive heart failure.\n* Autologous or allogenic SCT within 12 weeks before the first infusion or is planning for autologous SCT.\n* Symptomatic graft versus host disease post allogenic hemopoietic cell transplant within 12 months prior to the first study treatment infusion.\n* Radiotherapy within 21 days prior to the first study treatment infusion.\n* History of any other malignancy known to be active.\n* Known human immunodeficiency virus infection.\n* Patients with active infection requiring systemic anti-infective.\n* Patients with positive test results for hepatitis B surface antigen or Hepatitis B core antigen.\n* Patients with positive test results for hepatitis C virus (HCV) infection.\n* Current active liver or biliary disease.","ALL","18 Years",{"count":269,"type":270},78,"ESTIMATED","INTERVENTIONAL",[273,274],"PHASE1","PHASE2","This study will assess the safety, tolerability, pharmacokinetics (PK) and the therapeutic potential of HDP-101 in patients with plasma cell disorders including multiple myeloma.",[277,278],"Multiple Myeloma","Plasma Cell Disorder","2026-07-16",{"date":281,"type":282},"2026-07-17","ACTUAL",{"date":284,"type":282},"2022-02-07",{"date":286,"type":270},"2028-09",{"name":5,"class":6},24]