Metastatic solid tumor
Conditions
Interventions
Experimental group:68Ga/177Lu-BRP-020063 injection for treatment
Sponsors
Shanghai General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years old, gender not restricted; 2. Patients with confirmed advanced metastatic solid tumors (urinary bladder cancer is preferred, followed by breast cancer); 3. Agree to provide archived or fresh biopsy tumor tissue specimens (recommended within 2 years); 4. Physical condition (ECOG) score 0-1; 5. Adequate organ function: • Blood routine: white blood cell count >= 3.0×10^9/L, neutrophil count >= 1.5×10^9/L, hemoglobin >= 90g/L, platelet count >= 75×10^9/L; • Liver function: total bilirubin = 50mL/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 with reproductive capacity voluntarily take effective contraceptive measures during the treatment period and within 6 months after the last use of the study drug (for females); 7. Voluntarily participate in this trial and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Have previously received drugs targeting Nectin-4 (including clinical trials); 2. Unable to complete PET/CT or SPECT/CT examinations (including those who cannot lie flat, have claustrophobia, or radiation phobia, etc.); 3. Participated in drug or device clinical research within 4 weeks prior to the first administration; 4. Have severe or uncontrollable underlying diseases, including but not limited to: a) NYHA Class II or above congestive heart failure, or severe arrhythmia requiring medication; b) Severe cardiovascular or valvular diseases; c) Poorly controlled diabetes or hypertension; 5. Unable to tolerate intravenous administration and have difficulty in venous blood collection (such as having a history of fainting or hemophobia); 6. Had active infections within 4 weeks prior to the first administration; 7. Pregnant women, women in the preconception period, or lactating women; 8. Allergic to radioactive rays or have other severe allergic histories; 9. Have a history of neurological metastasis and related symptoms; 10. Have other malignant tumors; 11. Had general anesthesia surgery within 4 weeks prior to the first administration; 12. Other situations that the researcher deems not suitable for inclusion in the clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serious adverse event;Adverse event; | — |
Secondary
| Measure | Time frame |
|---|---|
| Radiation Dosimetry;PK Parameters;Disease control rate;Tissue Distribution;Objective response rate; | — |
Countries
China
Contacts
Public ContactYan Xing
Shanghai General Hospital
Outcome results
None listed