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Trial Title:
177Lu-labeled NY108 SPECT Imaging in Patients
NCT ID:
NCT05815394
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Study type:
Interventional
Study phase:
Early Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
177Lu-labeled NY108
Description:
Patients will receive a tracer (40-60ug) dose of 177Lu(28.5-31.5mCi) labelled NY108.
Arm group label:
177Lu-Anti-PSMA mAbs
Summary:
This is a single arm study to evaluate the safety and biodistribution of 177Lu-labeled
NY108 (177Lu-NY108) SPECT Imaging in patients.
Criteria for 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.
Gender:
Male
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Affiliated Hospital of Jiangnan University
Address:
City:
Wuxi
Zip:
214000
Country:
China
Status:
Recruiting
Contact:
Last name:
Chunjing Yu
Phone:
15312238622
Email:
ycj_wxd1978@163.com
Start date:
March 3, 2023
Completion date:
December 12, 2024
Lead sponsor:
Agency:
Affiliated Hospital of Jiangnan University
Agency class:
Other
Source:
Affiliated Hospital of Jiangnan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05815394
