177Lu-labeled NY108 SPECT Imaging in Patients

Affiliated Hospital of Jiangnan University

Status and phase: Enrolling; Early Phase 1

Conditions: Prostate Cancer

Treatments: Drug: 177Lu-labeled NY108

Study type: Interventional

Funder types: Other

Identifiers

NCT05815394

LS2023013

Details and patient eligibility

About

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

Enrollment: 10 estimated patients

Sex: Male

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

177Lu-Anti-PSMA mAbs

Experimental group

Treatment:

Drug: 177Lu-labeled NY108