[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100633676":3},{"organization":4,"outcomesModule":7,"designInfo":36,"detailedDescription":11,"studyPopulation":11,"armGroups":42,"interventions":49,"overallOfficials":11,"centralContacts":54,"locations":60,"responsibleParty":116,"collaborators":118,"id":121,"slug":11,"hasResults":122,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":11,"eligibilityCriteria":126,"healthyVolunteers":122,"sex":127,"minAge":11,"maxAge":128,"enrollmentInfo":129,"targetDuration":11,"studyType":132,"phases":133,"briefSummary":135,"conditions":136,"keywords":138,"overallStatus":63,"whyStopped":11,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":150},{"fullName":5,"class":6},"Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Number of patients who experience a dose-limiting toxicity (DLT) during the first cycle of treatment.",null,"Up to Day 21 (from first dose)",[14,18,21,24,27,30,33],{"measure":15,"description":16,"timeFrame":17},"Number of patients with serious and non-serious adverse events","Incidence and grading of adverse events (AEs) and serious adverse events (SAEs) (based on the National Cancer Institute's Common Terminology Criteria for Adverse Events \\[CTCAE\\] version 5.0). Incidence of treatment interruption and dose adjustment due to AEs and changes in laboratory tests, vital signs, physical examination and electrocardiogram (ECG).","Through study completion, an average of 1 year",{"measure":19,"description":20,"timeFrame":17},"Objective response rate (ORR)","Proportion of enrolled subjects who achieve a partial response (PR) or better, i.e. stringent complete response (sCR), complete response (CR), very good partial response (VGPR) and PR, according to the IMWG criteria.",{"measure":22,"description":23,"timeFrame":17},"Minimal residual disease (MRD) negativity rate","Proportion of enrolled subjects who achieve minimal residual disease (MRD) free status, according to the IMWG criteria.",{"measure":25,"description":26,"timeFrame":17},"Progression-free survival (PFS)","PFS is defined as the interval from the start of study therapy to the earlier of the first documentation of disease progression\u002Frelapse or death from any cause, whichever occurs first as determined by the investigator",{"measure":28,"description":29,"timeFrame":17},"Duration of response (DOR)","DOR is defined as the interval from the first documentation of PR or better until disease progression or death due to any cause, whichever occurs first",{"measure":31,"description":32,"timeFrame":17},"Time to objective response (TOR)","TOR is defined as the interval from the start of study therapy to the first documentation of PR or better",{"measure":34,"description":35,"timeFrame":17},"Overall survival (OS)","OS is defined as the time from randomization to death due to any cause",{"allocation":37,"interventionModel":38,"interventionModelDescription":11,"primaryPurpose":39,"observationalModel":11,"timePerspective":11,"maskingInfo":40},"NA","SINGLE_GROUP","TREATMENT",{"masking":41,"maskingDescription":11,"whoMasked":11},"NONE",[43],{"label":44,"type":45,"description":46,"interventionNames":47},"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.",[48],"Drug: HDP-101",[50],{"type":51,"name":44,"description":52,"armGroupLabels":53,"otherNames":11},"DRUG","HDP-101 is available as lyophilized white powder for preparation of infusion.",[44],[55],{"name":56,"role":57,"phone":58,"phoneExt":11,"email":59},"Jianfei Zhao","CONTACT","+8618428347838","zhaojianfei@eastchinapharm.com",[61,75,85,95,105],{"facility":62,"status":63,"city":64,"state":65,"zip":66,"country":67,"countryCode":68,"cosmosGeoPoint":69,"geoPoint":74,"contacts":11},"Beijing Chao-Yang Hospital, Capital Medical University","RECRUITING","Beijing","Beijing Municipality","100020","China","CN",{"type":70,"coordinates":71},"Point",[72,73],116.39723,39.9075,{"lat":73,"lon":72},{"facility":76,"status":63,"city":77,"state":78,"zip":79,"country":67,"countryCode":68,"cosmosGeoPoint":80,"geoPoint":84,"contacts":11},"The First Affiliated Hospital of Soochow University","Suzhou","Jiangsu","215006",{"type":70,"coordinates":81},[82,83],120.59538,31.30408,{"lat":83,"lon":82},{"facility":86,"status":63,"city":87,"state":88,"zip":89,"country":67,"countryCode":68,"cosmosGeoPoint":90,"geoPoint":94,"contacts":11},"Qilu Hospital of Shandong University","Jinan","Shandong","250012",{"type":70,"coordinates":91},[92,93],116.99722,36.66833,{"lat":93,"lon":92},{"facility":96,"status":63,"city":97,"state":98,"zip":99,"country":67,"countryCode":68,"cosmosGeoPoint":100,"geoPoint":104,"contacts":11},"Institute of Hematology & Blood Diseases Hospital,Chinese Academy of Medical Sciences","Tianjin","Tianjin Municipality","300020",{"type":70,"coordinates":101},[102,103],117.17667,39.14222,{"lat":103,"lon":102},{"facility":106,"status":107,"city":108,"state":109,"zip":110,"country":67,"countryCode":68,"cosmosGeoPoint":111,"geoPoint":115,"contacts":11},"The First Affiliated Hospital, Zhejiang University School of Medicine","NOT_YET_RECRUITING","Hangzhou","Zhejiang","310003",{"type":70,"coordinates":112},[113,114],120.16142,30.29365,{"lat":114,"lon":113},{"type":117,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[119],{"name":120,"class":6},"Heidelberg Pharma AG","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":130,"type":131},15,"ESTIMATED","INTERVENTIONAL",[134],"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.",[137],"Multiple Myeloma and Other Plasma Cell Neoplasms",[139,140],"multiple myeloma","myeloma","2026-04-13",{"date":143,"type":144},"2026-04-14","ACTUAL",{"date":146,"type":144},"2026-03-17",{"date":148,"type":131},"2026-12-31",{"name":5,"class":6},5]