[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100602547":3},{"organization":4,"outcomesModule":7,"designInfo":52,"detailedDescription":51,"studyPopulation":51,"armGroups":58,"interventions":75,"overallOfficials":51,"centralContacts":105,"locations":111,"responsibleParty":316,"collaborators":51,"id":318,"slug":51,"hasResults":319,"nctId":320,"briefTitle":321,"officialTitle":322,"acronym":51,"eligibilityCriteria":323,"healthyVolunteers":319,"sex":324,"minAge":325,"maxAge":326,"enrollmentInfo":327,"targetDuration":51,"studyType":330,"phases":331,"briefSummary":334,"conditions":335,"keywords":337,"overallStatus":114,"whyStopped":51,"lastUpdateSubmitDate":339,"lastUpdatePostDateStruct":340,"startDateStruct":343,"completionDateStruct":345,"leadSponsor":347,"locationsCount":348},{"fullName":5,"class":6},"Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":24,"otherOutcomes":51},[9,13,17,21],{"measure":10,"description":11,"timeFrame":12},"Number of participants who experience dose-limiting toxicities (DLTs) in dose-escalation part","The CTCAE, Version 5.0 will be used to grade the severity of AEs in this study. DLTs will be reported for dose-escalation part of this study.","Up to ~3 weeks",{"measure":14,"description":15,"timeFrame":16},"Number of participants who experience adverse events (AEs), serious adverse events (SAEs) and adverse events of special interest (AESIs) in dose-escalation part","Incidence and grading of adverse events (AEs), serious adverse events (SAEs), and adverse events of special interest (AESIs) (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, electrocardiogram (ECG), and Eastern Cooperative Oncology Group (ECOG) performance status score.","Up to ~54 months",{"measure":18,"description":19,"timeFrame":20},"Complete response (CR) rate in dose-expansion part","CR rate is defined as the percentage of participants who achieve a complete response (CR) per Lugano criteria, as determined by the investigator","Up to ~30 months",{"measure":22,"description":23,"timeFrame":20},"RP2D of HDM2005","Recommended phase 2 dose of HDM2005 in combination with SoC in patients with r\u002Fr DLBCL and untreated DLBCL",[25,28,31,33,36,39,42,45,48],{"measure":26,"description":27,"timeFrame":20},"Plasma concentration of HDM2005, total antibody and monomethyl auristatin E (MMAE)","Plasma concentration of HDM2005, total antibody and MMAE will be reported for each dose level",{"measure":29,"description":30,"timeFrame":20},"Number of participants positive for anti-drug antibodies (ADA)","Number of participants with positive ADA will be assessed",{"measure":32,"description":15,"timeFrame":16},"Number of participants who experience adverse events (AEs), serious adverse events (SAEs) and adverse events of special interest (AESIs) in dose-expansion part",{"measure":34,"description":35,"timeFrame":20},"Objective response rate (ORR)","ORR is defined as the percentage of participants who achieve a complete response (CR) or partial response (PR) per Lugano criteria as determined by the investigator",{"measure":37,"description":38,"timeFrame":16},"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":40,"description":41,"timeFrame":16},"Duration of response (DOR)","DOR is defined as the interval from the first documentation of CR or PR until disease progression or death due to any cause, whichever occurs first",{"measure":43,"description":44,"timeFrame":16},"Time to response (TTR)","TTR is defined as the interval from the start of study therapy to the first documentation of CR or PR",{"measure":46,"description":47,"timeFrame":16},"Time to progression (TTP)","TTP is defined as the interval from the start of study therapy to the earlier of the first documentation of disease progression as determined by the investigator",{"measure":49,"description":50,"timeFrame":16},"Overall survival (OS)","OS is defined as the time from randomization to death due to any cause",null,{"allocation":53,"interventionModel":54,"interventionModelDescription":51,"primaryPurpose":55,"observationalModel":51,"timePerspective":51,"maskingInfo":56},"NON_RANDOMIZED","SINGLE_GROUP","TREATMENT",{"masking":57,"maskingDescription":51,"whoMasked":51},"NONE",[59,68],{"label":60,"type":61,"description":62,"interventionNames":63},"Participants with r\u002Fr DLBCL (Cohort A)","EXPERIMENTAL","Participants with r\u002Fr DLBCL will receive a dose of HDM2005 (1.8 mg\u002Fkg or 2.0 mg\u002Fkg, on Day 2 Cycle 1 and Day 1 Cycle 2 to 6-8) plus 1000 mg\u002F m\\^2 gemcitabine (on Day 2 Cycle 1 and Day 1 Cycle 2 to 6-8), 100 mg\u002F m\\^2 oxaliplatin, and 375 mg\u002Fm\\^2 rituximab or rituximab biosimilar administered by intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 6-8 cycles.",[64,65,66,67],"Drug: HDM2005","Drug: Rituximab or Rituximab biosimilar","Drug: Gemcitabine","Drug: Oxaliplatin",{"label":69,"type":61,"description":70,"interventionNames":71},"Participants with untreated DLBCL (Cohort B)","Participants with untreated DLBCL will receive a dose of HDM2005 (1.8 mg\u002Fkg or 2.0 mg\u002Fkg, on Day 2 Cycle 1 and Day 1 Cycle 2 to 6) plus 750 mg\u002Fm\\^2 cyclophosphamide (on Day 2 Cycle 1 and Day 1 Cycle 2 to 6), 50 mg\u002Fm\\^2 doxorubicin (on Day 2 Cycle 1 and Day 1 Cycle 2 to 6), and 375 mg\u002Fm\\^2 rituximab or rituximab biosimilar administered by intravenous (IV) infusion on Day 1 and 2 Cycle 1 and Day 1 Cycle 2 to 6 of each 3-week cycle for up to 6 cycles. Participants will also receive 100 mg prednisone or prednisolone via oral tablet per day during Days 1-5 of each 3-week cycle for up to 6 cycles.",[64,65,72,73,74],"Drug: Cyclophosphamide","Drug: Doxorubicin","Drug: Prednisone",[76,81,85,89,93,97,101],{"type":77,"name":78,"description":79,"armGroupLabels":80,"otherNames":51},"DRUG","HDM2005","HDM2005 will be administered as an intravenous injection.",[60,69],{"type":77,"name":82,"description":83,"armGroupLabels":84,"otherNames":51},"Rituximab or Rituximab biosimilar","Rituximab or Rituximab biosimilar will be administered as an intravenous injection.",[60,69],{"type":77,"name":86,"description":87,"armGroupLabels":88,"otherNames":51},"Gemcitabine","Gemcitabine will be administered as an intravenous injection.",[60],{"type":77,"name":90,"description":91,"armGroupLabels":92,"otherNames":51},"Oxaliplatin","Oxaliplatin will be administered as an intravenous injection.",[60],{"type":77,"name":94,"description":95,"armGroupLabels":96,"otherNames":51},"Cyclophosphamide","Cyclophosphamide will be administered as an intravenous injection.",[69],{"type":77,"name":98,"description":99,"armGroupLabels":100,"otherNames":51},"Doxorubicin","Doxorubicin will be administered as an intravenous injection.",[69],{"type":77,"name":102,"description":103,"armGroupLabels":104,"otherNames":51},"Prednisone","Prednisone will be administered orally.",[69],[106],{"name":107,"role":108,"phone":109,"phoneExt":51,"email":110},"Meiping Kong","CONTACT","+8613735478976","cxykongmeiping@eastchinapharm.com",[112,126,137,147,157,167,177,183,193,199,209,219,229,239,249,259,269,279,289,300,306],{"facility":113,"status":114,"city":115,"state":116,"zip":117,"country":118,"countryCode":119,"cosmosGeoPoint":120,"geoPoint":125,"contacts":51},"Peking University Cancer Hospital","RECRUITING","Beijing","Beijing Municipality","100142","China","CN",{"type":121,"coordinates":122},"Point",[123,124],116.39723,39.9075,{"lat":124,"lon":123},{"facility":127,"status":128,"city":129,"state":130,"zip":131,"country":118,"countryCode":119,"cosmosGeoPoint":132,"geoPoint":136,"contacts":51},"Fujian Cancer Hospital","NOT_YET_RECRUITING","Fuzhou","Fujian","350000",{"type":121,"coordinates":133},[134,135],119.30611,26.06139,{"lat":135,"lon":134},{"facility":138,"status":128,"city":139,"state":140,"zip":141,"country":118,"countryCode":119,"cosmosGeoPoint":142,"geoPoint":146,"contacts":51},"Sun Yat-sen University Cancer Center","Guangzhou","Guangdong","510050",{"type":121,"coordinates":143},[144,145],113.25,23.11667,{"lat":145,"lon":144},{"facility":148,"status":128,"city":149,"state":150,"zip":151,"country":118,"countryCode":119,"cosmosGeoPoint":152,"geoPoint":156,"contacts":51},"The Affiliated Tumor Hospital of Guangxi Medical University","Nanning","Guangxi","530021",{"type":121,"coordinates":153},[154,155],108.31667,22.81667,{"lat":155,"lon":154},{"facility":158,"status":128,"city":159,"state":160,"zip":161,"country":118,"countryCode":119,"cosmosGeoPoint":162,"geoPoint":166,"contacts":51},"Affiliated Tumor Hospital of Harbin Medical University","Harbin","Heilongjiang","150081",{"type":121,"coordinates":163},[164,165],126.65,45.75,{"lat":165,"lon":164},{"facility":168,"status":128,"city":169,"state":170,"zip":171,"country":118,"countryCode":119,"cosmosGeoPoint":172,"geoPoint":176,"contacts":51},"The First Affiliated Hospital of Zhengzhou University","Zhengzhou","Henan","450000",{"type":121,"coordinates":173},[174,175],113.64861,34.75778,{"lat":175,"lon":174},{"facility":178,"status":128,"city":169,"state":170,"zip":179,"country":118,"countryCode":119,"cosmosGeoPoint":180,"geoPoint":182,"contacts":51},"Henan Cancer Hospital","450008",{"type":121,"coordinates":181},[174,175],{"lat":175,"lon":174},{"facility":184,"status":128,"city":185,"state":186,"zip":187,"country":118,"countryCode":119,"cosmosGeoPoint":188,"geoPoint":192,"contacts":51},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology","Wuhan","Hubei","430022",{"type":121,"coordinates":189},[190,191],114.26667,30.58333,{"lat":191,"lon":190},{"facility":194,"status":128,"city":185,"state":186,"zip":195,"country":118,"countryCode":119,"cosmosGeoPoint":196,"geoPoint":198,"contacts":51},"Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology","430030",{"type":121,"coordinates":197},[190,191],{"lat":191,"lon":190},{"facility":200,"status":128,"city":201,"state":202,"zip":203,"country":118,"countryCode":119,"cosmosGeoPoint":204,"geoPoint":208,"contacts":51},"HunanCancer Hospital","Changsha","Hunan","410023",{"type":121,"coordinates":205},[206,207],112.97087,28.19874,{"lat":207,"lon":206},{"facility":210,"status":128,"city":211,"state":212,"zip":213,"country":118,"countryCode":119,"cosmosGeoPoint":214,"geoPoint":218,"contacts":51},"Second Affiliated Hospital of Soochow University","Suzhou","Jiangsu","215005",{"type":121,"coordinates":215},[216,217],120.59538,31.30408,{"lat":217,"lon":216},{"facility":220,"status":128,"city":221,"state":222,"zip":223,"country":118,"countryCode":119,"cosmosGeoPoint":224,"geoPoint":228,"contacts":51},"The First Affiliated Hospital Of Nanchang University","Nanchang","Jiangxi","330000",{"type":121,"coordinates":225},[226,227],115.85306,28.68396,{"lat":227,"lon":226},{"facility":230,"status":128,"city":231,"state":232,"zip":233,"country":118,"countryCode":119,"cosmosGeoPoint":234,"geoPoint":238,"contacts":51},"The first hospital of Jilin University","Changchun","Jilin","130021",{"type":121,"coordinates":235},[236,237],125.32278,43.88,{"lat":237,"lon":236},{"facility":240,"status":128,"city":241,"state":242,"zip":243,"country":118,"countryCode":119,"cosmosGeoPoint":244,"geoPoint":248,"contacts":51},"Shengjing Hospital Affiliated to China Medical University","Shenyang","Liaoning","110004",{"type":121,"coordinates":245},[246,247],123.43278,41.79222,{"lat":247,"lon":246},{"facility":250,"status":128,"city":251,"state":252,"zip":253,"country":118,"countryCode":119,"cosmosGeoPoint":254,"geoPoint":258,"contacts":51},"The First Affiliated Hospital of Xi'an Jiaotong University","Xi'an","Shaanxi","710061",{"type":121,"coordinates":255},[256,257],108.92861,34.25833,{"lat":257,"lon":256},{"facility":260,"status":128,"city":261,"state":262,"zip":263,"country":118,"countryCode":119,"cosmosGeoPoint":264,"geoPoint":268,"contacts":51},"Cancer Hospital of Shandong First Medical University (Shandong Cancer Institute,Shandong Cancer Hospital)","Jinan","Shandong","250117",{"type":121,"coordinates":265},[266,267],116.99722,36.66833,{"lat":267,"lon":266},{"facility":270,"status":128,"city":271,"state":272,"zip":273,"country":118,"countryCode":119,"cosmosGeoPoint":274,"geoPoint":278,"contacts":51},"Shanxi Cancer Hospital","Taiyuan","Shanxi","030013",{"type":121,"coordinates":275},[276,277],112.56028,37.86944,{"lat":277,"lon":276},{"facility":280,"status":128,"city":281,"state":282,"zip":283,"country":118,"countryCode":119,"cosmosGeoPoint":284,"geoPoint":288,"contacts":51},"West China Hospital，Sichuan University","Chengdu","Sichuan","610041",{"type":121,"coordinates":285},[286,287],104.06667,30.66667,{"lat":287,"lon":286},{"facility":290,"status":291,"city":292,"state":293,"zip":294,"country":118,"countryCode":119,"cosmosGeoPoint":295,"geoPoint":299,"contacts":51},"The Second Affiliated Hospital of Kunming Medical UniversityThe Second Affiliated Hospital of Kunming Medical University","ACTIVE_NOT_RECRUITING","Kunming","Yunnan","650033",{"type":121,"coordinates":296},[297,298],102.71833,25.03889,{"lat":298,"lon":297},{"facility":301,"status":128,"city":292,"state":293,"zip":302,"country":118,"countryCode":119,"cosmosGeoPoint":303,"geoPoint":305,"contacts":51},"Yunnan Cancer Hospital","650118",{"type":121,"coordinates":304},[297,298],{"lat":298,"lon":297},{"facility":307,"status":128,"city":308,"state":309,"zip":310,"country":118,"countryCode":119,"cosmosGeoPoint":311,"geoPoint":315,"contacts":51},"The First Affiliated Hospital, Zhejiang University School of Medicine","Hangzhou","Zhejiang","310003",{"type":121,"coordinates":312},[313,314],120.16142,30.29365,{"lat":314,"lon":313},{"type":317,"investigatorFullName":51,"investigatorTitle":51,"investigatorAffiliation":51,"oldNameTitle":51,"oldOrganization":51},"SPONSOR","100602547",false,"NCT07124936","A Study of HDM2005 in Combination With Standard of Care in Patients With Diffuse Large B-Cell Lymphoma","A Phase 1b\u002F2 Study to Evaluate the Safety, Tolerability, and Antitumor Activity of HDM2005 in Combination With Standard of Care in Patients With Diffuse Large B-Cell Lymphoma","Inclusion Criteria:\n\n1. Male or female aged 18-75 years.\n2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n3. Life expectancy \\>12 weeks.\n4. Histologically confirmed diffuse large B-cell lymphoma (DLBCL).\n\n   a. Cohort B: International Prognostic Index (IPI) score of 2-5.\n5. Prior treatment:\n\n   1. Cohort A: At least one (≥1) line of prior systemic therapy.\n   2. Cohort B: Has received no prior treatment for DLBCL.\n6. At least one bi-dimensionally measurable (≥1.5 cm) nodal lesion, or one bi-dimensionally measurable (≥1 cm) extranodal lesion, as measured on computed tomography (CT) scan.\n7. Adequate organ system and hematologic function as defined in protocol.\n\nExclusion Criteria:\n\n1. Known active central nervous system (CNS) lymphoma.\n2. Prior of allogeneic hematopoietic stem cell transplantation and has acute or ongoing graft-versus-host disease (GVHD) of any grade.\n3. Known additional malignancy that is progressing or has required active treatment within the past 3 years.\n4. History of severe bleeding disorders.\n5. History of interstitial lung disease or radiation pneumonitis.\n6. Prior solid organ transplant.\n7. Ongoing Grade \\>1 treatment-related adverse events.\n8. Current or history of clinically significant cardiovascular and cerebrovascular diseases.\n9. Active infection requiring systemic therapy.\n10. Concurrent active HBV or HCV infection or known history of human immunodeficiency virus (HIV) infection.\n11. Prior ROR1-targeted therapy.\n12. Ongoing corticosteroid therapy.\n13. Current active autoimmune disease or history of autoimmune disease requiring treatment.\n14. History of drug anaphylaxis or severe food allergy.\n15. Any history or current evidence of disease, treatment, or laboratory abnormality as determined by the investigator that may affect the study results, interfere with the subject's full participation in the study, or be contrary to the subject's best interests.","ALL","18 Years","75 Years",{"count":328,"type":329},97,"ESTIMATED","INTERVENTIONAL",[332,333],"PHASE1","PHASE2","The purpose of this phase 1b\u002F2 study is to evaluate the safety, tolerability, and antitumor activity of HDM2005 in combination with standard of care in participants with diffuse large B-cell lymphoma. This study will include two arms: Cohort A (HDM2005 + R-GemOx) will enroll participants with relapsed\u002Frefractory DLBCL. Cohort B (HDM2005 + R-CHP) will enroll participants with untreated DLBCL. The study will consist of two parts: dose-escalation part and dose-expansion part.",[336],"Diffuse Large B Cell Lymphoma (DLBCL)",[338],"DLBCL","2025-08-11",{"date":341,"type":342},"2025-08-15","ACTUAL",{"date":344,"type":342},"2025-07-30",{"date":346,"type":329},"2029-10-25",{"name":5,"class":6},21]