177Lu-labeled NY108 SPECT Imaging in Patients

NCT ID: NCT05815394

Last Updated: 2023-04-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-03
• Study Completion Date: 2024-12-12

Brief Summary

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

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

177Lu-Anti-PSMA mAbs

Group Type: EXPERIMENTAL

177Lu-labeled NY108

Intervention Type: DRUG

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

Interventions

177Lu-labeled NY108

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

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Affiliated Hospital of Jiangnan University

OTHER

Sponsor Role: lead

Responsible Party

Chunjing Yu

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chunjing Yu

Role: PRINCIPAL_INVESTIGATOR

Affiliated Hospital of Jiangnan University

Locations

Affiliated Hospital of Jiangnan University

Wuxi, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Chunjing Yu

Role: CONTACT

ycj_wxd1978@163.com

15312238622

Facility Contacts

Chunjing Yu

Role: primary

ycj_wxd1978@163.com

15312238622

Other Identifiers

LS2023013

Identifier Type: -

Identifier Source: org_study_id