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

Inclusion criteria

• Age ≥ 18 years, regardless of gender;
• Patients with a confirmed diagnosis of advanced metastatic solid tumor (preferably urothelial carcinoma, followed by breast cancer);
• Willing to provide archived or freshly biopsied tumor tissue specimens (recommended within the past 2 years);
• Performance status (ECOG) score of 0-1;
• 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;
• 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);
• Willing to participate in this trial and sign an informed consent form.

Exclusion criteria

• Previous treatment with Nectin-4-targeted drugs (including clinical trials);
• Inability to complete PET/CT or SPECT/CT examinations (including inability to lie flat, claustrophobia, radiophobia, etc.);
• Participation in drug or device clinical studies within 4 weeks prior to the first dose;
• Presence of severe or uncontrolled underlying diseases, including but not limited to:

• NYHA Class II or higher congestive heart failure, or severe arrhythmia requiring medication;
• Severe cardiovascular/cerebrovascular or valvular diseases;
• Poorly controlled diabetes or hypertension;
• Inability to tolerate intravenous administration or difficulty with venipuncture (e.g., history of needle or blood phobia);
• Active infection within 4 weeks prior to the first dose;
• Women who are planning pregnancy, currently pregnant, or breastfeeding;
• Allergy to radioactive rays or other severe allergic history;
• History of neurological metastasis with associated symptoms;
• Concurrent other malignancies;
• Undergone general anesthesia surgery within 4 weeks prior to the first dose;
• Other conditions deemed by the investigator as unsuitable for inclusion in the clinical study.