177Lu-labeled NY108 SPECT Imaging in Patients

• Status: Recruiting
• Trial end date: 2024-12-12
• Target enrollment: 0
• Participant gender: Male

Summary

This is a single arm study to evaluate the safety and biodistribution of 177Lu-labeled NY108 (177Lu-NY108) SPECT Imaging in patients.

• 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;

2. Age 18-75, male;

3. Clinical diagnosis of prostate cancer with diagnostic criteria referencing biopsy and at least one metastasis;

4. Patients must be 68Ga-NY108 Positron Emission Tomography (PET)/Computed Tomography (CT) scan positive;

5. Patients must have received at least one NAAD (such as enzalutamide and/or abiraterone) and at least one paclitaxel regimen;

6. Progressive metastatic destructive resistant prostate cancer as determined by PCWG3 criteria;

7. An ECOG score of 0-2

Exclusion Criteria:

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

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

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

4. Patients with autoimmune diseases, including rheumatoid, etc;

5. Inadequately controlled arrhythmias, including atrial fibrillation:

6. Cardiac insufficiency (New York Heart Association (NYHA) work class criteria);

7. Uncontrolled hypertension;

8. Patients with a history of allergy or hypersensitivity to any component of the imaging agent, including antibodies;

9. Subjects positive for syphilis, HBV, HCV, FIIV;

10. Subjects of childbearing age who are unable to use effective contraceptive devices:

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

12. Patients who are unable or unavailable for SPECT/CT scanning;

13. Other subjects who, in the opinion of the investigator, are not suitable for enrollment.