177Lu-labeled NY108 SPECT Imaging in Patients

Prostate Cancer Clinical Trial

Official title:

177Lu-labeled NY108 SPECT Imaging in Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05815394
• Other study ID #: LS2023013
• Status: Recruiting
• Phase: Early Phase 1
• Start date: March 3, 2023
• Est. completion date: December 12, 2024

Study information

• Verified date: April 2023
• Source: Affiliated Hospital of Jiangnan University
• Contact: Chunjing Yu
• Phone: 15312238622
• Email: ycj_wxd1978[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 12, 2024
• Est. primary completion date: March 3, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• 177Lu-labeled NY108
Patients will receive a tracer (40-60ug) dose of 177Lu(28.5-31.5mCi) labelled NY108.

Locations

Country	Name	City	State
China	Affiliated Hospital of Jiangnan University	Wuxi	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Affiliated Hospital of Jiangnan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of tissue distribution of 177Lu-Anti-PSMA mAbs(NY108)	Biodistribution of 177Lu-Anti-PSMA mAbs(NY108) evaluated by radioactive uptake values (standardized uptake values, SUVs) in various organs during repeated 177Lu-SPECT scans will be reported.	1 year
Primary	Incidence of Treatment-Emergent Adverse Events	Safety will be assessed by evaluation of incidence of adverse events.	1 year