[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100626706":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":20,"locations":26,"responsibleParty":42,"collaborators":11,"id":46,"slug":47,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":11,"eligibilityCriteria":52,"healthyVolunteers":48,"sex":53,"minAge":54,"maxAge":11,"enrollmentInfo":55,"targetDuration":11,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":11,"overallStatus":29,"whyStopped":11,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":73},{"fullName":5,"class":6},"Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"⁶⁸Ga\u002F¹⁷⁷Lu-BRP-020063 Treatment Arm","EXPERIMENTAL",null,[13],"Drug: ⁶⁸Ga\u002F¹⁷⁷Lu-BRP-020063",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"DRUG","⁶⁸Ga\u002F¹⁷⁷Lu-BRP-020063","68Ga-BRP-020063 Injection (Diagnostic Phase): All subjects will receive a single administration of 68Ga-BRP-020063 injection. The dose of 5 mCi (185 MBq), within an acceptable range of 3-7 mCi (111-259 MBq), will be delivered via rapid consecutive intravenous bolus injection in a volume not exceeding 10 mL, followed by a saline flush.\n\n177Lu-BRP-020063 Injection (Therapeutic Phase): Five subjects who show positive results on the 68Ga-BRP-020063 PET\u002FCT scan will be selected to receive a single administration of 177Lu-BRP-020063 injection. A dose of 40 mCi (1.48 GBq), within an acceptable range of 30-50 mCi (1.11-1.85 GBq), will be administered via intravenous infusion over approximately 20 minutes using an infusion pump, followed by a saline flush.",[9],[21],{"name":22,"role":23,"phone":24,"phoneExt":11,"email":25},"Yan Xing, Dr.","CONTACT","+862163246311","xy.1@163.com",[27],{"facility":28,"status":29,"city":30,"state":11,"zip":11,"country":31,"countryCode":32,"cosmosGeoPoint":33,"geoPoint":38,"contacts":39},"Shanghai General Hospital","RECRUITING","Shanghai","China","CN",{"type":34,"coordinates":35},"Point",[36,37],121.45806,31.22222,{"lat":37,"lon":36},[40],{"name":41,"role":23,"phone":24,"phoneExt":11,"email":25},"Yan Xing, MD",{"type":43,"investigatorFullName":44,"investigatorTitle":45,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Yan Xing","Medical Director","100626706","early-phase-1-safety-and-tolerability-study-of-68ga177lu-brp-020063-in-advanced-solid-tumors-100626706",false,"NCT07439120","Safety and Tolerability Study of 68Ga\u002F177Lu-BRP-020063 in Advanced Solid Tumors","A Study Evaluating the Safety, Pharmacokinetics, and Radiation Dosimetry of 68Ga\u002F177Lu-BRP-020063 in Patients With Advanced Metastatic Solid Tumors.","Inclusion Criteria:\n\n1. Age ≥ 18 years, regardless of gender;\n2. Patients with a confirmed diagnosis of advanced metastatic solid tumor (preferably urothelial carcinoma, followed by breast cancer);\n3. Willing to provide archived or freshly biopsied tumor tissue specimens (recommended within the past 2 years);\n4. Performance status (ECOG) score of 0-1;\n5. Adequate organ function:\n\n   * Complete Blood Count: White blood cell count ≥ 3.0 × 10⁹\u002FL, neutrophil count ≥ 1.5 × 10⁹\u002FL, hemoglobin ≥ 90 g\u002FL, platelet count ≥ 75 × 10⁹\u002FL;\n   * Liver function: Total bilirubin ≤ 2.5 × ULN, alanine aminotransferase ≤ 3 × ULN, aspartate aminotransferase ≤ 3 × ULN;\n   * Renal function: Creatinine clearance ≥ 50 mL\u002Fmin (Cockcroft-Gault formula);\n   * Coagulation function: Prothrombin time ≤ 1.5 × ULN, activated partial thromboplastin time ≤ 1.5 × ULN, international normalized ratio ≤ 1.5 × ULN;\n6. Subjects of childbearing potential must voluntarily adopt effective contraception during the treatment period and for 6 months after the last dose of the investigational drug (for females);\n7. Willing to participate in this trial and sign an informed consent form.\n\nExclusion Criteria:\n\n1. Previous treatment with Nectin-4-targeted drugs (including clinical trials);\n2. Inability to complete PET\u002FCT or SPECT\u002FCT examinations (including inability to lie flat, claustrophobia, radiophobia, etc.);\n3. Participation in drug or device clinical studies within 4 weeks prior to the first dose;\n4. Presence of severe or uncontrolled underlying diseases, including but not limited to:\n\n   1. NYHA Class II or higher congestive heart failure, or severe arrhythmia requiring medication;\n   2. Severe cardiovascular\u002Fcerebrovascular or valvular diseases;\n   3. Poorly controlled diabetes or hypertension;\n5. Inability to tolerate intravenous administration or difficulty with venipuncture (e.g., history of needle or blood phobia);\n6. Active infection within 4 weeks prior to the first dose;\n7. Women who are planning pregnancy, currently pregnant, or breastfeeding;\n8. Allergy to radioactive rays or other severe allergic history;\n9. History of neurological metastasis with associated symptoms;\n10. Concurrent other malignancies;\n11. Undergone general anesthesia surgery within 4 weeks prior to the first dose;\n12. Other conditions deemed by the investigator as unsuitable for inclusion in the clinical study.","ALL","18 Years",{"count":56,"type":57},10,"ESTIMATED","INTERVENTIONAL",[60],"EARLY_PHASE1","This study is an open-label, single-arm, interventional clinical trial designed to investigate the safety of ⁶⁸Ga\u002F¹⁷⁷Lu-BRP-020063 in patients with advanced metastatic solid tumors; to evaluate the pharmacokinetics, biodistribution, and radiation dosimetry of ¹⁷⁷Lu-BRP-020063 in patients with metastatic solid tumors; and to preliminarily explore its therapeutic efficacy. The study plans to enroll 10 patients to receive ⁶⁸Ga-BRP-020063 PET\u002FCT imaging, among whom 5 patients positive for ⁶⁸Ga-BRP-020063 will be selected to receive a low dose of ¹⁷⁷Lu-BRP-020063. The results of this study will provide a basis for the design of subsequent studies involving higher doses of ¹⁷⁷Lu-BRP-020063.",[63],"Urothelial Carcinoma (UC)","2026-06-01",{"date":66,"type":67},"2026-06-03","ACTUAL",{"date":69,"type":67},"2026-04-13",{"date":71,"type":57},"2026-08-31",{"name":5,"class":6},1]