Safety Study of 177Lu-Anti-ED-B mAbs SPECT Imaging in Patients With ED-B Positive Solid Tumors

• Status: Not yet recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a single arm study to evaluate the safety and biodistribution of 177Lu-labeled anti-ED-B mAbs SPECT imaging in patients with ED-B positive solid tumors.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Affiliated Hospital of Jiangnan University

Criteria

Inclusion Criteria:

1. Patients voluntarily signed informed consent, and be able to complete the trial according to the requirement of the scheme;

2. Aged 18-75, male or female;

3. Patients diagnosed with solid tumors confirmed by histopathology ;

4. Patients with biopsy-proven fibronectin ED-B positive;

5. At least one measurable solid lesions has been examined by 18F-FDG PET/CT (RECIST1.1 standard);

6. ECOG score 0~2;

7. ALT, AST shall not exceed 3 times of the normal upper limit; Bun, Cr not exceed 1.5 times of the normal upper limit.

8. Other routine examinations are within the normal range or considered acceptable by the researchers.

Exclusion Criteria:

1. Recovery from major trauma (including surgery) within 4 weeks prior to study treatment;

2. Patients with systemic or locally severe infections, or other serious coexisting diseases;

3. Patients with abnormal immune function or who have recently used immunosuppressive or potentiating agents including various vaccines;

4. Patients with autoimmune diseases, including rheumatoid arthritis;

5. Inadequate control of arrhythmias, including atrial fibrillation;

6. Uncontrolled hypertension;

7. Patients with allergies or allergies to any component of the imaging agent or antibody;

8. Patients who cannot undergo PET/CT imaging scan;

9. Syphilis, HBV, HCV, or HIV positive subjects;

10. Male and female subjects of reproductive age cannot take effective contraceptive measures;

11. Pregnant or lactating women;

12. Patients with a history of mental illness or related conditions;

13. Other subjects considered unsuitable by researchers.