177Lu-labeled NY108 SPECT Imaging in Patients

Early Phase 1

Recruiting

• Conditions: Prostate Cancer
• Interventions: Drug: 177Lu-labeled NY108

• Registration Number: NCT05815394
• Lead Sponsor: Affiliated Hospital of Jiangnan University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-03
• Status Verified: 2023-04
• Study First Submitted: 2023-04-04
• Study First Submitted QC: 2023-04-04
• Last Update Submitted: 2023-04-04
• Study First Posted: 2023-04-18
• Last Update Posted: 2023-04-18
• Primary Completion: 2024-03-03
• Study Completion: 2024-12-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
177Lu-Anti-PSMA mAbs	177Lu-labeled NY108	-

Primary Outcome Measures

Name	Time	Method
Evaluation of tissue distribution of 177Lu-Anti-PSMA mAbs(NY108)	1 year	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.
Incidence of Treatment-Emergent Adverse Events	1 year	Safety will be assessed by evaluation of incidence of adverse events.

Trial Locations

Locations (1)

Affiliated Hospital of Jiangnan University; 🇨🇳 Wuxi, Jiangsu, China