177Lu-labeled NY108 SPECT Imaging in Patients

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

Official Title
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177Lu-labeled NY108 SPECT Imaging in Patients

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: 177Lu-labeled NY108


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients voluntarily signed informed consent; Age 18-75, male; Clinical diagnosis of prostate cancer with diagnostic criteria referencing biopsy and at least one metastasis; Patients must be 68Ga-NY108 Positron Emission Tomography (PET)/Computed Tomography (CT) scan positive; Patients must have received at least one NAAD (such as enzalutamide and/or abiraterone) and at least one paclitaxel regimen; Progressive metastatic destructive resistant prostate cancer as determined by PCWG3 criteria; An ECOG score of 0-2 Exclusion Criteria: Recovery from major trauma (including surgery) within 4 weeks prior to study treatment; Patients with severe systemic or localized infections or other serious coexisting diseases; Patients with abnormal immune function or who have recently used immunosuppressive or booster agents including various vaccines, etc; Patients with autoimmune diseases, including rheumatoid, etc; Inadequately controlled arrhythmias, including atrial fibrillation: Cardiac insufficiency (New York Heart Association (NYHA) work class criteria); Uncontrolled hypertension; Patients with a history of allergy or hypersensitivity to any component of the imaging agent, including antibodies; Subjects positive for syphilis, HBV, HCV, FIIV; Subjects of childbearing age who are unable to use effective contraceptive devices: Patients with a history of mental illness or related medical conditions; Patients who are unable or unavailable for SPECT/CT scanning; Other subjects who, in the opinion of the investigator, are not suitable for enrollment.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 177Lu-Anti-PSMA mAbs<br> | Drug: 177Lu-labeled NY108<br>* Patients will receive a tracer (40-60ug) dose of 177Lu(28.5-31.5mCi) labelled NY108.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Incidence of Treatment-Emergent Adverse Events | Safety will be assessed by evaluation of incidence of adverse events. | 1 year |