[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100526809":3},{"organization":4,"outcomesModule":7,"designInfo":67,"detailedDescription":66,"studyPopulation":66,"armGroups":73,"interventions":79,"overallOfficials":84,"centralContacts":87,"locations":92,"responsibleParty":224,"collaborators":66,"id":226,"slug":227,"hasResults":228,"nctId":229,"briefTitle":230,"officialTitle":231,"acronym":66,"eligibilityCriteria":232,"healthyVolunteers":228,"sex":233,"minAge":234,"maxAge":66,"enrollmentInfo":235,"targetDuration":66,"studyType":238,"phases":239,"briefSummary":242,"conditions":243,"keywords":245,"overallStatus":95,"whyStopped":66,"lastUpdateSubmitDate":246,"lastUpdatePostDateStruct":247,"startDateStruct":250,"completionDateStruct":252,"leadSponsor":254,"locationsCount":255},{"fullName":5,"class":6},"Bivision Pharmaceuticals, Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":23,"otherOutcomes":66},[9,13,16,19],{"measure":10,"description":11,"timeFrame":12},"Dose Limiting Toxicity (DLT) (Phase 1)","Incidence of adverse events, serious adverse events, and clinical laboratory abnormalities defined as dose-limiting toxicities (DLTs).","Up to 2 years follow up",{"measure":14,"description":15,"timeFrame":12},"Maximum Tolerated Dose (MTD) (Phase 1)","The maximum tolerated dose is among the explored dose levels.",{"measure":17,"description":18,"timeFrame":12},"Recommended Phase 2 Dose (RP2D) (Phase 1)","To identify the expansion phase dose of Lutetium Lu 177 JH020002 Injection.",{"measure":20,"description":21,"timeFrame":22},"PSA response rate","PSA response rate is the proportion of PSA responders, defined as a participant who has achieved PSA decrease of \\>= 50% from baseline that is confirmed by a second consecutive PSA measurement \\>= 4 weeks later. Determination of response status will be based on PCWG3 recommendations.","Up to 3 years follow up",[24,27,30,32,34,36,38,40,42,45,48,51,54,57,60,63],{"measure":25,"description":26,"timeFrame":12},"Radiation Dosimetry","Absorbed dose estimated in organs and tumor lesions.",{"measure":28,"description":29,"timeFrame":12},"Maximum plasma concentration (Cmax)","Pharmacokinetics (PK) characterization of Lutetium Lu 177 JH020002.",{"measure":31,"description":29,"timeFrame":12},"Time to maximum plasma concentration (Tmax)",{"measure":33,"description":29,"timeFrame":12},"Terminal elimination half-life (t1\u002F2)",{"measure":35,"description":29,"timeFrame":12},"Total systemic clearance (CL)",{"measure":37,"description":29,"timeFrame":12},"Area under the plasma concentration-time curve from time zero to the last measurable concentration (AUC0-t)",{"measure":39,"description":29,"timeFrame":12},"Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC0-inf)",{"measure":41,"description":29,"timeFrame":12},"Volume of distribution (Vz) during the terminal phase following intravenous elimination",{"measure":43,"description":44,"timeFrame":22},"Radiographic Progression-free Survival (rPFS)","Radiographic progression free survival (rPFS) is defined as the time of radiographic progression by Prostate Cancer Working Group 3 (PCWG3)-modified RECIST V1.1.",{"measure":46,"description":47,"timeFrame":22},"Disease control Rate (DCR)","Disease control rate (DCR) is defined as the proportion of participants with best overall response of complete response or partial response or Stable disease in soft tissue according to PCWG3 modified RECIST 1.1.",{"measure":49,"description":50,"timeFrame":22},"Duration of Response (DoR)","Duration of response (DOR) is defined as the duration of time between the date of first documented response (CR or PR) in soft tissue as per BIRC and according to PCWG3 modified RECIST 1.1, and the date of first documented progression or death due to any cause.",{"measure":52,"description":53,"timeFrame":22},"Time to First Subsequent Therapy (TFST)","Time to First Subsequent Therapy (TFST) is defined as the time from the date of first administration of investigational drug to the date of the first subsequent therapy of the prostate cancer.",{"measure":55,"description":56,"timeFrame":22},"Overall Survival (OS)","Overall survival (OS) is defined as the time from the date of first administration of investigational drug to the date of death due to any cause.",{"measure":58,"description":59,"timeFrame":22},"Time to Symptomatic Skeletal Event (TTSSE)","Time to a first symptomatic skeletal event (TTSSE) is defined as date of first administration of investigational drug to the date of first new symptomatic pathological bone fracture, spinal cord compression, tumor-related orthopedic surgical intervention, requirement for radiation therapy to relieve bone pain or death from any cause, whichever occurs first.",{"measure":61,"description":62,"timeFrame":22},"Incidence and severity of Adverse Events (AEs) and Serious Adverse Event (SAEs)","Analysis of frequencies and severity for Adverse Events (AEs) and Serious Adverse Event (SAEs), through the monitoring of relevant clinical and laboratory safety parameters.",{"measure":64,"description":65,"timeFrame":12},"Objective Response Rate (ORR) (Phase 2)","Proportion of participants with Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR). ORR was based on the Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria response for patients with measurable disease at baseline.",null,{"allocation":68,"interventionModel":69,"interventionModelDescription":66,"primaryPurpose":70,"observationalModel":66,"timePerspective":66,"maskingInfo":71},"NA","SEQUENTIAL","TREATMENT",{"masking":72,"maskingDescription":66,"whoMasked":66},"NONE",[74],{"label":75,"type":76,"description":66,"interventionNames":77},"Lutetium Lu 177 JH020002 Injection","EXPERIMENTAL",[78],"Drug: Lutetium Lu 177 JH020002 Injection",[80],{"type":81,"name":75,"description":82,"armGroupLabels":83,"otherNames":66},"DRUG","Patients will receive Lutetium Lu 177 JH020002 Injection every 6 weeks for a maximum of 6 doses. Doses range between 1.85 and 8.88 GBq (50-240 mCi)",[75],[85],{"name":5,"affiliation":5,"role":86},"STUDY_DIRECTOR",[88],{"name":5,"role":89,"phone":90,"phoneExt":66,"email":91},"CONTACT","86-21-50886996","bivision.public1@bivisionpharma.com",[93,106,115,124,133,143,152,161,169,178,197,206,215],{"facility":94,"status":95,"city":96,"state":97,"zip":66,"country":98,"countryCode":99,"cosmosGeoPoint":100,"geoPoint":105,"contacts":66},"Anhui Provincial Hospital","RECRUITING","Hefei","Anhui","China","CN",{"type":101,"coordinates":102},"Point",[103,104],117.28083,31.86389,{"lat":104,"lon":103},{"facility":107,"status":95,"city":108,"state":109,"zip":66,"country":98,"countryCode":99,"cosmosGeoPoint":110,"geoPoint":114,"contacts":66},"Peking University First Hospital","Beijing","Beijing Municipality",{"type":101,"coordinates":111},[112,113],116.39723,39.9075,{"lat":113,"lon":112},{"facility":116,"status":95,"city":117,"state":118,"zip":66,"country":98,"countryCode":99,"cosmosGeoPoint":119,"geoPoint":123,"contacts":66},"The First Affiliated Hospital of Fujian Medical University","Fuzhou","Fujian",{"type":101,"coordinates":120},[121,122],119.30611,26.06139,{"lat":122,"lon":121},{"facility":125,"status":95,"city":126,"state":127,"zip":66,"country":98,"countryCode":99,"cosmosGeoPoint":128,"geoPoint":132,"contacts":66},"Sun Yat-Sen University Cancer Center","Guangzhou","Guangdong",{"type":101,"coordinates":129},[130,131],113.25,23.11667,{"lat":131,"lon":130},{"facility":134,"status":135,"city":136,"state":137,"zip":66,"country":98,"countryCode":99,"cosmosGeoPoint":138,"geoPoint":142,"contacts":66},"Henan Cancer Hospital","NOT_YET_RECRUITING","Zhengzhou","Henan",{"type":101,"coordinates":139},[140,141],113.64861,34.75778,{"lat":141,"lon":140},{"facility":144,"status":95,"city":145,"state":146,"zip":66,"country":98,"countryCode":99,"cosmosGeoPoint":147,"geoPoint":151,"contacts":66},"Huazhong University of Science and Technology Tongji Medical College Affiliated Union Hospital","Wuhan","Hubei",{"type":101,"coordinates":148},[149,150],114.26667,30.58333,{"lat":150,"lon":149},{"facility":153,"status":95,"city":154,"state":155,"zip":66,"country":98,"countryCode":99,"cosmosGeoPoint":156,"geoPoint":160,"contacts":66},"The First Affiliated Hospital of Soochow University","Suzhou","Jiangsu",{"type":101,"coordinates":157},[158,159],120.59538,31.30408,{"lat":159,"lon":158},{"facility":162,"status":135,"city":163,"state":155,"zip":66,"country":98,"countryCode":99,"cosmosGeoPoint":164,"geoPoint":168,"contacts":66},"Affiliated Hospital of Jiangsu University","Wuxi",{"type":101,"coordinates":165},[166,167],120.28857,31.56887,{"lat":167,"lon":166},{"facility":170,"status":95,"city":171,"state":172,"zip":66,"country":98,"countryCode":99,"cosmosGeoPoint":173,"geoPoint":177,"contacts":66},"Shandong Cancer Hospital","Jinan","Shandong",{"type":101,"coordinates":174},[175,176],116.99722,36.66833,{"lat":176,"lon":175},{"facility":179,"status":95,"city":180,"state":181,"zip":182,"country":98,"countryCode":99,"cosmosGeoPoint":183,"geoPoint":187,"contacts":188},"Fudan University Shanghai Cancer Center","Shanghai","Shanghai Municipality","200032",{"type":101,"coordinates":184},[185,186],121.45806,31.22222,{"lat":186,"lon":185},[189,193],{"name":190,"role":89,"phone":191,"phoneExt":66,"email":192},"Dingwei Ye, M.D.","+8613701663571","fuscc2012@163.com",{"name":194,"role":89,"phone":195,"phoneExt":66,"email":196},"Shaoli Song, M.D.","+8613816608573","shaoli-song@163.com",{"facility":198,"status":95,"city":199,"state":200,"zip":66,"country":98,"countryCode":99,"cosmosGeoPoint":201,"geoPoint":205,"contacts":66},"West China Hospital of Sichuan University","Chengdu","Sichuan",{"type":101,"coordinates":202},[203,204],104.06667,30.66667,{"lat":204,"lon":203},{"facility":207,"status":95,"city":208,"state":209,"zip":66,"country":98,"countryCode":99,"cosmosGeoPoint":210,"geoPoint":214,"contacts":66},"Tianjin Cancer Hospital Airport Hospital","Tianjin","Tianjin Municipality",{"type":101,"coordinates":211},[212,213],117.17667,39.14222,{"lat":213,"lon":212},{"facility":216,"status":95,"city":217,"state":218,"zip":66,"country":98,"countryCode":99,"cosmosGeoPoint":219,"geoPoint":223,"contacts":66},"Zhejiang Provincial People's Hospital","Hangzhou","Zhejiang",{"type":101,"coordinates":220},[221,222],120.16142,30.29365,{"lat":222,"lon":221},{"type":225,"investigatorFullName":66,"investigatorTitle":66,"investigatorAffiliation":66,"oldNameTitle":66,"oldOrganization":66},"SPONSOR","100526809","phase-1-phase-12-clinical-study-of-lutetium-lu-177-jh020002-injection-in-patients-with-advanced-prostate-cancer-100526809",false,"NCT06139575","Phase 1\u002F2 Clinical Study of Lutetium Lu 177 JH020002 Injection in Patients With Advanced Prostate Cancer","Phase 1\u002F2 Clinical Study to Evaluate the Safety, Tolerability, Radiation Dosimetry and Preliminary Efficacy of Lutetium Lu 177 JH020002 Injection in Patients With Advanced Prostate Cancer","Inclusion Criteria:\n\n* Subjects are required to get informed consent prior to the trial and sign a written informed consent form voluntarily.\n* Male, age ≥18 years.\n* ECOG score 0 - 2.\n* Must have a life expectancy \\>6 months.\n* Histologically and\u002For cytologically confirmed adenocarcinoma of the prostate (except for those with neuroendocrine or small cell prostate cancer clinical features).\n* Participants must have a castrate level of serum\u002Fplasma testosterone (\\\u003C 50 ng\u002Fdl, or \\\u003C 1.7nmol\u002FL).\n\nExclusion Criteria:\n\n* Diagnosed with other malignancies, apart from: adequately treated skin basal cell carcinoma or superficial bladder cancers from which the patient has been disease-free for more than 3 years as confirmed by a physician.\n* Participants with a history of central nervous system (CNS) metastases who are neurologically unstable, symptomatic, or receiving corticosteroids for the purpose of maintaining neurologic integrity.\n* Previous treatment with Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223 or hemi-body irradiation \\\u003C6 months prior to date of first administration of investigational drug.\n* Previous PSMA-targeted radioligand therapy.\n* Previous radiotherapy for prostate cancer within 4 weeks prior to date of first administration of investigational drug.\n* Any systemic anti-cancer therapy (e.g. chemotherapy, immunotherapy, poly adenosine diphosphate-ribosyl polymerase inhibitors (PARPi) or biological therapy within 4 weeks prior to date of first administration of investigational drug.\n* Must not take part in other investigational therapies within 4 weeks prior to date of first administration of investigational drug.\n* History of hypersensitivity to any of the study drugs or its excipients or to drugs of similar chemical classes.","MALE","18 Years",{"count":236,"type":237},90,"ESTIMATED","INTERVENTIONAL",[240,241],"PHASE1","PHASE2","The study is being conducted to evaluate the safety, tolerability, pharmacokinetics, radiation dosimetry, and preliminary efficacy of Lutetium Lu 177 JH020002 Injection in adult patients with advanced prostate cancer.",[244],"Prostate Cancer",[244],"2026-10-07",{"date":248,"type":249},"2026-10-09","ACTUAL",{"date":251,"type":249},"2023-12-22",{"date":253,"type":237},"2027-07",{"name":5,"class":6},13]