Safety and Tolerability Study of 68Ga/177Lu-BRP-020063 in Advanced Solid Tumors

Inclusion Criteria: 1. Age ≥ 18 years, regardless of gender; 2. Patients with a confirmed diagnosis of advanced metastatic solid tumor (preferably urothelial carcinoma, followed by breast cancer); 3. Willing to provide archived or freshly biopsied tumor tissue specimens (recommended within the past 2 years); 4. Performance status (ECOG) score of 0-1; 5. Adequate organ function: * Complete Blood Count: White blood cell count ≥ 3.0 × 10⁹/L, neutrophil count ≥ 1.5 × 10⁹/L, hemoglobin ≥ 90 g/L, platelet count ≥ 75 × 10⁹/L; * Liver function: Total bilirubin ≤ 2.5 × ULN, alanine aminotransferase ≤ 3 × ULN, aspartate aminotransferase ≤ 3 × ULN; * Renal function: Creatinine clearance ≥ 50 mL/min (Cockcroft-Gault formula); * Coagulation function: Prothrombin time ≤ 1.5 × ULN, activated partial thromboplastin time ≤ 1.5 × ULN, international normalized ratio ≤ 1.5 × ULN; 6. 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); 7. Willing to participate in this trial and sign an informed consent form. Exclusion Criteria: 1. Previous treatment with Nectin-4-targeted drugs (including clinical trials); 2. Inability to complete PET/CT or SPECT/CT examinations (including inability to lie flat, claustrophobia, radiophobia, etc.); 3. Participation in drug or device clinical studies within 4 weeks prior to the first dose; 4. Presence of severe or uncontrolled underlying diseases, including but not limited to: 1. NYHA Class II or higher congestive heart failure, or severe arrhythmia requiring medication; 2. Severe cardiovascular/cerebrovascular or valvular diseases; 3. Poorly controlled diabetes or hypertension; 5. Inability to tolerate intravenous administration or difficulty with venipuncture (e.g., history of needle or blood phobia); 6. Active infection within 4 weeks prior to the first dose; 7. Women who are planning pregnancy, currently pregnant, or breastfeeding; 8. Allergy to radioactive rays or other severe allergic history; 9. History of neurological metastasis with associated symptoms; 10. Concurrent other malignancies; 11. Undergone general anesthesia surgery within 4 weeks prior to the first dose; 12. Other conditions deemed by the investigator as unsuitable for inclusion in the clinical study.