177Lu-labeled NY108 SPECT Imaging in Patients

Last updated: April 4, 2023
Sponsor: Affiliated Hospital of Jiangnan University
Overall Status: Active - Recruiting

Phase

1

Condition

Prostate Cancer

Urologic Cancer

Prostate Cancer, Early, Recurrent

Treatment

N/A

Clinical Study ID

NCT05815394
LS2023013
  • Ages 18-75
  • Male

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients voluntarily signed informed consent;
  2. Age 18-75, male;
  3. Clinical diagnosis of prostate cancer with diagnostic criteria referencing biopsy andat 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/orabiraterone) and at least one paclitaxel regimen;
  6. Progressive metastatic destructive resistant prostate cancer as determined by PCWG3criteria;
  7. An ECOG score of 0-2

Exclusion

Exclusion Criteria:

  1. Recovery from major trauma (including surgery) within 4 weeks prior to studytreatment;
  2. Patients with severe systemic or localized infections or other serious coexistingdiseases;
  3. Patients with abnormal immune function or who have recently used immunosuppressive orbooster 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 imagingagent, 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 forenrollment.

Study Design

Total Participants: 10
Study Start date:
March 03, 2023
Estimated Completion Date:
December 12, 2024

Connect with a study center

  • Affiliated Hospital of Jiangnan University

    Wuxi, Jiangsu 214000
    China

    Active - Recruiting

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