[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100429974":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":26,"responsibleParty":182,"collaborators":19,"id":184,"slug":185,"hasResults":186,"nctId":187,"briefTitle":188,"officialTitle":189,"acronym":19,"eligibilityCriteria":190,"healthyVolunteers":186,"sex":191,"minAge":192,"maxAge":19,"enrollmentInfo":193,"targetDuration":19,"studyType":196,"phases":197,"briefSummary":200,"conditions":201,"keywords":19,"overallStatus":29,"whyStopped":19,"lastUpdateSubmitDate":204,"lastUpdatePostDateStruct":205,"startDateStruct":208,"completionDateStruct":210,"leadSponsor":212,"locationsCount":213},{"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",[27,41,50,60,72,81,90,99,108,117,126,136,147,153,164,173],{"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":29,"city":43,"state":43,"zip":44,"country":33,"countryCode":34,"cosmosGeoPoint":45,"geoPoint":49,"contacts":19},"Mount Sinai, The Tisch Cancer Instutute","New York","10029",{"type":36,"coordinates":46},[47,48],-74.00597,40.71427,{"lat":48,"lon":47},{"facility":51,"status":29,"city":52,"state":53,"zip":54,"country":33,"countryCode":34,"cosmosGeoPoint":55,"geoPoint":59,"contacts":19},"MD Anderson Cancer Center","Houston","Texas","77030",{"type":36,"coordinates":56},[57,58],-95.36327,29.76328,{"lat":58,"lon":57},{"facility":61,"status":62,"city":63,"state":19,"zip":64,"country":65,"countryCode":66,"cosmosGeoPoint":67,"geoPoint":71,"contacts":19},"Charité - Campus Benjamin Franklin Med. Klinik m.S. Hämatologie, Onkologie","NOT_YET_RECRUITING","Berlin","12203","Germany","DE",{"type":36,"coordinates":68},[69,70],13.41053,52.52437,{"lat":70,"lon":69},{"facility":73,"status":29,"city":74,"state":19,"zip":75,"country":65,"countryCode":66,"cosmosGeoPoint":76,"geoPoint":80,"contacts":19},"Klinikum Chemnitz gGmbH, Klinik f. Innere Medizin III","Chemnitz","09116",{"type":36,"coordinates":77},[78,79],12.92922,50.8357,{"lat":79,"lon":78},{"facility":82,"status":29,"city":83,"state":19,"zip":84,"country":65,"countryCode":66,"cosmosGeoPoint":85,"geoPoint":89,"contacts":19},"Universitätsklinikum Köln","Cologne","50937",{"type":36,"coordinates":86},[87,88],6.95,50.93333,{"lat":88,"lon":87},{"facility":91,"status":29,"city":92,"state":19,"zip":93,"country":65,"countryCode":66,"cosmosGeoPoint":94,"geoPoint":98,"contacts":19},"Asklepios Klinik Altona, Haematologie und internistische Onkologie","Hamburg","22763",{"type":36,"coordinates":95},[96,97],9.99302,53.55073,{"lat":97,"lon":96},{"facility":100,"status":29,"city":101,"state":19,"zip":102,"country":65,"countryCode":66,"cosmosGeoPoint":103,"geoPoint":107,"contacts":19},"Universitätsklinikum Heidelberg","Heidelberg","69120",{"type":36,"coordinates":104},[105,106],8.69079,49.40768,{"lat":106,"lon":105},{"facility":109,"status":29,"city":110,"state":19,"zip":111,"country":65,"countryCode":66,"cosmosGeoPoint":112,"geoPoint":116,"contacts":19},"Universitätsklinikum Schleswig-Holstein","Kiel","24105",{"type":36,"coordinates":113},[114,115],10.13489,54.32133,{"lat":115,"lon":114},{"facility":118,"status":29,"city":119,"state":19,"zip":120,"country":65,"countryCode":66,"cosmosGeoPoint":121,"geoPoint":125,"contacts":19},"UKSH Campus Lübeck Klinik für Hämatologie und Onkologie","Lübeck","23538",{"type":36,"coordinates":122},[123,124],10.68729,53.86893,{"lat":124,"lon":123},{"facility":127,"status":128,"city":129,"state":19,"zip":130,"country":65,"countryCode":66,"cosmosGeoPoint":131,"geoPoint":135,"contacts":19},"Universitätsklinikum Mainz","WITHDRAWN","Mainz","55131",{"type":36,"coordinates":132},[133,134],8.28008,49.98185,{"lat":134,"lon":133},{"facility":137,"status":29,"city":138,"state":19,"zip":139,"country":140,"countryCode":141,"cosmosGeoPoint":142,"geoPoint":146,"contacts":19},"Semmelweis University, Belgyogyaszati es Onkologiai Klinika","Budapest","1083","Hungary","HU",{"type":36,"coordinates":143},[144,145],19.04045,47.49835,{"lat":145,"lon":144},{"facility":148,"status":29,"city":138,"state":19,"zip":149,"country":140,"countryCode":141,"cosmosGeoPoint":150,"geoPoint":152,"contacts":19},"National Institute of Oncology, Department of Oncological Internal Medicine","1122",{"type":36,"coordinates":151},[144,145],{"lat":145,"lon":144},{"facility":154,"status":29,"city":155,"state":19,"zip":156,"country":157,"countryCode":158,"cosmosGeoPoint":159,"geoPoint":163,"contacts":19},"Pratia Onkologia Katowice","Katowice","40-519","Poland","PL",{"type":36,"coordinates":160},[161,162],19.02173,50.2597,{"lat":162,"lon":161},{"facility":165,"status":62,"city":166,"state":19,"zip":167,"country":157,"countryCode":158,"cosmosGeoPoint":168,"geoPoint":172,"contacts":19},"Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi","Lodz","93-513",{"type":36,"coordinates":169},[170,171],19.47395,51.77058,{"lat":171,"lon":170},{"facility":174,"status":62,"city":175,"state":19,"zip":176,"country":157,"countryCode":158,"cosmosGeoPoint":177,"geoPoint":181,"contacts":19},"Szpital Wojewodzki w Opolu","Opole","45-061",{"type":36,"coordinates":178},[179,180],17.92604,50.67119,{"lat":180,"lon":179},{"type":183,"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":194,"type":195},78,"ESTIMATED","INTERVENTIONAL",[198,199],"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.",[202,203],"Multiple Myeloma","Plasma Cell Disorder","2024-07-22",{"date":206,"type":207},"2024-07-24","ACTUAL",{"date":209,"type":207},"2022-02-07",{"date":211,"type":195},"2026-05",{"name":5,"class":6},16]