[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100633676":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":26,"responsibleParty":82,"collaborators":84,"id":87,"slug":88,"hasResults":89,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":19,"eligibilityCriteria":93,"healthyVolunteers":89,"sex":94,"minAge":19,"maxAge":95,"enrollmentInfo":96,"targetDuration":19,"studyType":99,"phases":100,"briefSummary":102,"conditions":103,"keywords":105,"overallStatus":29,"whyStopped":19,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},{"fullName":5,"class":6},"Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.","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 part 1 tolerability of two or three different dose levels will be evaluated. During the part 2 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},"Jianfei Zhao","CONTACT","+8618428347838","zhaojianfei@eastchinapharm.com",[27,41,51,61,71],{"facility":28,"status":29,"city":30,"state":31,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":19},"Beijing Chao-Yang Hospital, Capital Medical University","RECRUITING","Beijing","Beijing Municipality","100020","China","CN",{"type":36,"coordinates":37},"Point",[38,39],116.39723,39.9075,{"lat":39,"lon":38},{"facility":42,"status":29,"city":43,"state":44,"zip":45,"country":33,"countryCode":34,"cosmosGeoPoint":46,"geoPoint":50,"contacts":19},"The First Affiliated Hospital of Soochow University","Suzhou","Jiangsu","215006",{"type":36,"coordinates":47},[48,49],120.59538,31.30408,{"lat":49,"lon":48},{"facility":52,"status":29,"city":53,"state":54,"zip":55,"country":33,"countryCode":34,"cosmosGeoPoint":56,"geoPoint":60,"contacts":19},"Qilu Hospital of Shandong University","Jinan","Shandong","250012",{"type":36,"coordinates":57},[58,59],116.99722,36.66833,{"lat":59,"lon":58},{"facility":62,"status":29,"city":63,"state":64,"zip":65,"country":33,"countryCode":34,"cosmosGeoPoint":66,"geoPoint":70,"contacts":19},"Institute of Hematology & Blood Diseases Hospital,Chinese Academy of Medical Sciences","Tianjin","Tianjin Municipality","300020",{"type":36,"coordinates":67},[68,69],117.17667,39.14222,{"lat":69,"lon":68},{"facility":72,"status":73,"city":74,"state":75,"zip":76,"country":33,"countryCode":34,"cosmosGeoPoint":77,"geoPoint":81,"contacts":19},"The First Affiliated Hospital, Zhejiang University School of Medicine","NOT_YET_RECRUITING","Hangzhou","Zhejiang","310003",{"type":36,"coordinates":78},[79,80],120.16142,30.29365,{"lat":80,"lon":79},{"type":83,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR",[85],{"name":86,"class":6},"Heidelberg Pharma AG","100633676","phase-1-study-to-assess-safety-and-efficacy-of-hdp-101-in-chinese-patients-with-relapsed-or-refractory-multiple-myeloma-100633676",false,"NCT07529782","Study to Assess Safety and Efficacy of HDP-101 in Chinese Patients With Relapsed or Refractory Multiple Myeloma","A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of HDP-101 in Chinese 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 (Dose-escalation part only: patients with non-secretory or oligo-secretory myeloma (NSMM) not meeting the measurability criteria are eligible).\n* Adequate organ system function as defined in protocol.\n\nExclusion Criteria:\n\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 therapy.\n* Patients with positive hepatitis B virus (HBV) infection or positive hepatitis C virus (HCV) infection.\n* Current active liver or biliary disease.\n* Pregnancy or breast feeding.\n* Pneumonia or symptomatic pneumonitis.","ALL","18 Years",{"count":97,"type":98},15,"ESTIMATED","INTERVENTIONAL",[101],"PHASE1","This study is a 2-part study with a dose-escalation part and a dose-expansion part. The aim of the dose-escalation part is to determine the maximum tolerated dose (MTD) and\u002For establish the recommended Phase 2 dose (RP2D) in the Chinese population, in order to select the treatment dose for the dose-expansion part. The dose-escalation part will be followed by the dose-expansion part once the MTD(s) and\u002For RP2D of HDP-101 monotherapy in the Chinese population have been determined. The dose-expansion part of the study is intended to collect preliminary evidence of antitumor activity and to confirm the safety of the HDP-101 as monotherapy in Chinese patients with r\u002Fr MM.",[104],"Multiple Myeloma and Other Plasma Cell Neoplasms",[106,107],"multiple myeloma","myeloma","2026-04-13",{"date":110,"type":111},"2026-04-14","ACTUAL",{"date":113,"type":111},"2026-03-17",{"date":115,"type":98},"2026-12-31",{"name":5,"class":6},5]