[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100600159":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":21,"centralContacts":26,"locations":36,"responsibleParty":55,"collaborators":59,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":66,"acronym":21,"eligibilityCriteria":67,"healthyVolunteers":64,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":21,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":39,"whyStopped":21,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm A","EXPERIMENTAL","mCRPC subjects with IHC 1+\u002FIHC 2+\u002FIHC3+ are administered Disitamab Vedotin combined with Abiraterone",[13,14],"Drug: Disitamab Vedotin (RC48)","Drug: Abiraterone + prednisone",[16,22],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","Disitamab Vedotin (RC48)","Disitamab Vedotin 2mg\u002Fkg is administered intravenously once every 2 weeks (1 cycle)",[9],null,{"type":17,"name":23,"description":24,"armGroupLabels":25,"otherNames":21},"Abiraterone + prednisone","Abiraterone 1000mg is administered orally once a day，and prednisone 5mg is administered orally twice a day.",[9],[27,32],{"name":28,"role":29,"phone":30,"phoneExt":21,"email":31},"Hongqian Guo Hong qian Guo","CONTACT","8613605171690","gymwpi@126.com",{"name":33,"role":29,"phone":34,"phoneExt":21,"email":35},"Shun Zhang Shun Zhang","8615050589789","gymwgcp@126.com",[37],{"facility":38,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Nanjing, Jiangsu 210000","RECRUITING","Nanjing","Jiangsu","210000","China","CN",{"type":46,"coordinates":47},"Point",[48,49],118.77778,32.06167,{"lat":49,"lon":48},[52],{"name":53,"role":29,"phone":30,"phoneExt":21,"email":54},"Hongqian Guo Hongqian Guo, PhD","dr.ghq@nju.edu.cn",{"type":56,"investigatorFullName":57,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":21,"oldOrganization":21},"PRINCIPAL_INVESTIGATOR","Hongqian Guo","Chief physician",[60],{"name":61,"class":6},"Nanjing University","100600159","phase-2-efficacy-and-safety-of-disitamab-vedotin-plus-abiraterone-for-metastatic-castration-resistant-prostate-cancera-phase-ii-study-100600159",false,"NCT07093866","Efficacy and Safety of Disitamab Vedotin Plus Abiraterone for Metastatic Castration-Resistant Prostate Cancer：a Phase II Study","Inclusion Criteria:\n\n* Patients are able to understand and voluntarily sign the informed consent form (ICF); judged by the investigator to be capable of complying with the protocol.\n* Male patients of ≥18 years or older at the time of ICF signature.\n* Patients with ECOG performance status 0-1.\n* Patients with an expected survival of 3months or more.\n* Patients who are histologically or cytologically confirmed prostatic adenocarcinoma with HER2 expression (IHC 1+, 2+ or 3+) in archival or fresh tumour tissue.\n* Patients with documented castration-resistant prostate cancer (CRPC): serum testosterone \\\u003C1.73 nmol\u002FL (50 ng\u002FdL) at screening; patients on medical castration must continue LHRH agonist\u002Fantagonist therapy throughout the study.\n* Patients with evidence of metastatic disease by bone scan (bone lesions) and\u002For CT\u002FMRI (soft-tissue lesions).\n* Patients with adequate organ function as defined below:\n\n  * Absolute neutrophil count (ANC) ≥1.5 × 10⁹\u002FL\n  * Platelet count (PLT) ≥100 × 10⁹\u002FL\n  * Hemoglobin (Hb) ≥100 g\u002FL\n  * Total bilirubin (TBIL) ≤1.5 × upper limit of normal (ULN); ≤2 × ULN if liver metastases present\n  * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤1.5 × ULN; ≤2 × ULN if liver metastases present\n  * Serum creatinine (Cr) ≤1.5 × ULN or calculated creatinine clearance (CrCl) ≥60 mL\u002Fmin (Cockcroft-Gault formula; calculate only if Cr \\>1.5 × ULN)\n  * Urinalysis protein \\\u003C2+; if ≥2+, 24-h urine protein must be \\\u003C1 g or urine protein\u002Fcreatinine ratio \\\u003C0.5\n  * For patients not on anticoagulation: INR and aPTT ≤1.5 × ULN; patients on stable-dose anticoagulation are eligible\n  * Left ventricular ejection fraction (LVEF) ≥50% or ≥local lower limit of normal (LLN), whichever is lower\n  * QTcF interval \\\u003C470 ms\n* Male patients with partners of child-bearing potential must use a medically acceptable contraceptive method from the first study dose until 3 months after the last dose.\n\nExclusion Criteria:\n\n* Patients who are known hypersensitivity to any component of disitamab vedotin or abiraterone.\n* Patients with other malignancies within 3 years before screening, except early-stage malignancies considered clinically cured (carcinoma in situ or stage I tumors), e.g., basal-cell or squamous-cell skin carcinoma or superficial bladder cancer.\n* Patients with central nervous system (CNS) metastases and\u002For carcinomatous meningitis. Patients with treated brain metastases may enroll if lesions have been stable for ≥1 month, there is no evidence of new or enlarging CNS disease, and systemic corticosteroids have been discontinued ≥3 days before the first study dose.\n* Patients who are clinically significant pericardial effusion, or pleural\u002Fperitoneal\u002Fpelvic effusions that are poorly controlled or require drainage within 2 weeks before the first dose.\n* Patients with major surgical intervention (any grade 3 or 4 procedure per the 2009 Chinese Regulation on Clinical Application of Medical Technologies) within 4 weeks before the first dose, or incomplete post-operative recovery that, in the investigator's judgment, poses a risk to trial participation.\n* Patients who are prior PSMA-targeted therapy.\n* Patients within 4 weeks (6 weeks for nitrosoureas or mitomycin C) before the first dose: any antineoplastic chemotherapy (except castration therapy), radiotherapy (\\>1 week of local palliative radiotherapy permitted), endocrine therapy (estrogens or anti-androgens; bicalutamide or nilutamide require 6-week washout), targeted therapy, immunotherapy, or participation in another interventional clinical trial (observational studies or post-trial follow-up are allowed).\n\n  * Patients with stable-dose denosumab or bisphosphonates for bone metastases are permitted.\n  * mCRPC patients must not have used PSA-lowering herbal agents (e.g., saw palmetto) or systemic corticosteroids (except short courses for allergy prophylaxis\u002Ftreatment) within 4 weeks before the first dose, nor plan to use such agents during the study.\n* Patients with use of antineoplastic traditional Chinese medicine (TCM) prescriptions or proprietary TCM within 1 week, or receipt of blood transfusion\u002Fblood products, hematopoietic growth factors, or other agents to correct blood cell counts within 2 weeks before first study dose.\n* Patients with toxicities from prior antineoplastic therapy that have not resolved to baseline, CTCAE v5.0 grade 0-1 (except alopecia and pigmentation), or to the levels specified in the inclusion\u002Fexclusion criteria; unhealed wounds. Irreversible toxicities not expected to worsen with study drug (e.g., hearing loss) are permitted.\n* Patients with unexplained fever \\>38.5 °C (tumor-related fever may be allowed per investigator judgment); active or persistent infection; HIV antibody positive; HBsAg positive with HBV DNA \\> site ULN, or HBsAg-negative\u002FHBcAb-positive with HBV DNA \\> site ULN after treatment; HCV antibody positive with HCV RNA \\> site ULN; active syphilis (except adequately treated, cured, or stable syphilis).\n* NYHA class III\u002FIV congestive heart failure; uncontrolled arrhythmia despite treatment\u002Fintervention; risk of QT prolongation or use of drugs known to prolong QT; refractory hypertension (hypertension controlled to \\\u003C140\u002F90 mmHg on medication is allowed).\n* Patients with clinically significant vascular events within 6 months before first dose, including acute arterial\u002Fvenous thromboembolism, thrombotic arteritis, thrombophlebitis, acute pulmonary embolism, acute coronary syndrome (MI, unstable angina, etc.), acute cerebrovascular events, or disseminated intravascular coagulation.\n* Patients with tumor metastases with clear invasion of major arteries posing a high bleeding risk.\n* Patients with interstitial pneumonitis, pulmonary fibrosis, or other severe pulmonary disease requiring treatment; hemoptysis \\>2.5 mL per episode within 3 weeks before first dose.\n* Patients with active gastro-intestinal ulcer, perforation, and\u002For fistula requiring treatment within 6 months; GI bleeding (hematemesis, melena, or hematochezia) within 3 months without endoscopic\u002Fcolonoscopic evidence of complete healing.\n* Patients with uncontrolled concurrent disease \\>CTCAE v5.0 grade 2 (e.g., diabetes).\n\nUncontrolled concurrent disease \\>CTCAE v5.0 grade 2 (e.g., diabetes).\n\n* Patients with CTCAE v5.0 grade \\>2 peripheral neuropathy, prior epilepsy, psychiatric disorders; history of drug abuse within 6 months or alcohol abuse within 3 months (alcohol abuse defined as \\>14 units\u002Fweek: 1 unit = 285 mL beer, 25 mL spirits, or 80 mL wine).\n* Patients with autoimmune disease, immunodeficiency, or organ transplantation.\n* Patients with any condition, therapy, or laboratory abnormality that, in the investigator's opinion, could confound results, interfere with trial participation, or be not in the subject's best interest.","MALE","18 Years","75 Years",{"count":72,"type":73},20,"ESTIMATED","INTERVENTIONAL",[76],"PHASE2","This is an open-label，prospective，single-arm，phase 2 trial aims to evaluate the efficacy and safety of disitamab vedotin combined with abiraterone in patients with metastatic castration-resistant prostate cancer.",[79],"mCRPC",[79],"2025-07-22",{"date":83,"type":84},"2025-07-30","ACTUAL",{"date":86,"type":73},"2025-07-20",{"date":88,"type":73},"2027-12-30",{"name":5,"class":6},1]