[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100429974":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":26,"responsibleParty":178,"collaborators":19,"id":180,"slug":19,"hasResults":181,"nctId":182,"briefTitle":183,"officialTitle":184,"acronym":19,"eligibilityCriteria":185,"healthyVolunteers":181,"sex":186,"minAge":187,"maxAge":19,"enrollmentInfo":188,"targetDuration":19,"studyType":191,"phases":192,"briefSummary":195,"conditions":196,"keywords":19,"overallStatus":29,"whyStopped":19,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":200,"startDateStruct":203,"completionDateStruct":205,"leadSponsor":207,"locationsCount":208},{"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},"András Strassz, MD","CONTACT","+ 49 6203 1009 0","clinical@hdpharma.com",[27,40,49,59,70,79,88,97,106,115,124,134,144,150,160,169],{"facility":28,"status":29,"city":30,"state":31,"zip":32,"country":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":19},"Winship Cancer Institute of Emory University","RECRUITING","Atlanta","Georgia","30322","United States",{"type":35,"coordinates":36},"Point",[37,38],-84.38798,33.749,{"lat":38,"lon":37},{"facility":41,"status":29,"city":42,"state":42,"zip":43,"country":33,"cosmosGeoPoint":44,"geoPoint":48,"contacts":19},"Mount Sinai, The Tisch Cancer Instutute","New York","10029",{"type":35,"coordinates":45},[46,47],-74.00597,40.71427,{"lat":47,"lon":46},{"facility":50,"status":29,"city":51,"state":52,"zip":53,"country":33,"cosmosGeoPoint":54,"geoPoint":58,"contacts":19},"MD Anderson Cancer Center","Houston","Texas","77030",{"type":35,"coordinates":55},[56,57],-95.36327,29.76328,{"lat":57,"lon":56},{"facility":60,"status":61,"city":62,"state":19,"zip":63,"country":64,"cosmosGeoPoint":65,"geoPoint":69,"contacts":19},"Charité - Campus Benjamin Franklin Med. Klinik m.S. Hämatologie, Onkologie","NOT_YET_RECRUITING","Berlin","12203","Germany",{"type":35,"coordinates":66},[67,68],13.41053,52.52437,{"lat":68,"lon":67},{"facility":71,"status":29,"city":72,"state":19,"zip":73,"country":64,"cosmosGeoPoint":74,"geoPoint":78,"contacts":19},"Klinikum Chemnitz gGmbH, Klinik f. Innere Medizin III","Chemnitz","09116",{"type":35,"coordinates":75},[76,77],12.92922,50.8357,{"lat":77,"lon":76},{"facility":80,"status":29,"city":81,"state":19,"zip":82,"country":64,"cosmosGeoPoint":83,"geoPoint":87,"contacts":19},"Universitätsklinikum Köln","Cologne","50937",{"type":35,"coordinates":84},[85,86],6.95,50.93333,{"lat":86,"lon":85},{"facility":89,"status":29,"city":90,"state":19,"zip":91,"country":64,"cosmosGeoPoint":92,"geoPoint":96,"contacts":19},"Asklepios Klinik Altona, Haematologie und internistische Onkologie","Hamburg","22763",{"type":35,"coordinates":93},[94,95],9.99302,53.55073,{"lat":95,"lon":94},{"facility":98,"status":29,"city":99,"state":19,"zip":100,"country":64,"cosmosGeoPoint":101,"geoPoint":105,"contacts":19},"Universitätsklinikum Heidelberg","Heidelberg","69120",{"type":35,"coordinates":102},[103,104],8.69079,49.40768,{"lat":104,"lon":103},{"facility":107,"status":29,"city":108,"state":19,"zip":109,"country":64,"cosmosGeoPoint":110,"geoPoint":114,"contacts":19},"Universitätsklinikum Schleswig-Holstein","Kiel","24105",{"type":35,"coordinates":111},[112,113],10.13489,54.32133,{"lat":113,"lon":112},{"facility":116,"status":29,"city":117,"state":19,"zip":118,"country":64,"cosmosGeoPoint":119,"geoPoint":123,"contacts":19},"UKSH Campus Lübeck Klinik für Hämatologie und Onkologie","Lübeck","23538",{"type":35,"coordinates":120},[121,122],10.68729,53.86893,{"lat":122,"lon":121},{"facility":125,"status":126,"city":127,"state":19,"zip":128,"country":64,"cosmosGeoPoint":129,"geoPoint":133,"contacts":19},"Universitätsklinikum Mainz","WITHDRAWN","Mainz","55131",{"type":35,"coordinates":130},[131,132],8.28008,49.98185,{"lat":132,"lon":131},{"facility":135,"status":29,"city":136,"state":19,"zip":137,"country":138,"cosmosGeoPoint":139,"geoPoint":143,"contacts":19},"Semmelweis University, Belgyogyaszati es Onkologiai Klinika","Budapest","1083","Hungary",{"type":35,"coordinates":140},[141,142],19.04045,47.49835,{"lat":142,"lon":141},{"facility":145,"status":29,"city":136,"state":19,"zip":146,"country":138,"cosmosGeoPoint":147,"geoPoint":149,"contacts":19},"National Institute of Oncology, Department of Oncological Internal Medicine","1122",{"type":35,"coordinates":148},[141,142],{"lat":142,"lon":141},{"facility":151,"status":29,"city":152,"state":19,"zip":153,"country":154,"cosmosGeoPoint":155,"geoPoint":159,"contacts":19},"Pratia Onkologia Katowice","Katowice","40-519","Poland",{"type":35,"coordinates":156},[157,158],19.02173,50.2597,{"lat":158,"lon":157},{"facility":161,"status":61,"city":162,"state":19,"zip":163,"country":154,"cosmosGeoPoint":164,"geoPoint":168,"contacts":19},"Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi","Lodz","93-513",{"type":35,"coordinates":165},[166,167],19.47395,51.77058,{"lat":167,"lon":166},{"facility":170,"status":61,"city":171,"state":19,"zip":172,"country":154,"cosmosGeoPoint":173,"geoPoint":177,"contacts":19},"Szpital Wojewodzki w Opolu","Opole","45-061",{"type":35,"coordinates":174},[175,176],17.92604,50.67119,{"lat":176,"lon":175},{"type":179,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","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":189,"type":190},78,"ESTIMATED","INTERVENTIONAL",[193,194],"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.",[197,198],"Multiple Myeloma","Plasma Cell Disorder","2024-07-22",{"date":201,"type":202},"2024-07-24","ACTUAL",{"date":204,"type":202},"2022-02-07",{"date":206,"type":190},"2026-05",{"name":5,"class":6},16]