68Ga-labeled NY108 PET Imaging in Patients

Early Phase 1

Recruiting

• Conditions: Prostatic Cancer
• Interventions: Drug: 68Ga-labeled NY108

• Registration Number: NCT05623878
• Lead Sponsor: Affiliated Hospital of Jiangnan University

Brief Summary

This is a single arm study to evaluate the safety and biodistribution of 68Ga-labeled NY108 (68Ga-NY108) PET Imaging in patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-04
• Status Verified: 2022-11
• Study First Submitted: 2022-11-15
• Study First Submitted QC: 2022-11-15
• Study First Posted: 2022-11-21
• Last Update Submitted: 2022-11-27
• Last Update Posted: 2022-12-01
• Primary Completion: 2023-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 100

Inclusion Criteria

1. Patients voluntarily signed informed consent;
2. Age 18-75, male;
3. Patients diagnosed with prostatic cancer confirmed by histopathology or cytology;
4. At least one measurable solid lesion has been examined according RECIST1.1 standard;
5. Patients with biopsy-proven PSMA positive;
6. ECOG score 0~3; Life expectancy of at least 3 months;

Exclusion Criteria

1. Recovery from major trauma (including surgery) within 4 weeks prior to study treatment;
2. Patients with systemic or locally severe infections, or other serious coexisting diseases;
3. Patients with allergies or allergies to any component of the imaging agent or antibody;
4. Patients who cannot perform PET/CT imaging scan;
5. Patients with abnormal immune function or who have recently used immunosuppressive or potentiating agents including various vaccines;
6. Patients with autoimmune diseases, including rheumatoid arthritis; Inadequate control of arrhythmias, including atrial fibrillation;
7. Uncontrolled hypertension;
8. Syphilis, HBV, HCV, or HIV positive subjects;
9. Male subjects of reproductive age cannot take effective contraceptive measures;
10. Patients with a history of mental illness or related conditions;
11. Other subjects considered unsuitable by researchers.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
68Ga-Anti-PSMA mAbs	68Ga-labeled NY108	-

Primary Outcome Measures

Name	Time	Method
Evaluation of tissue distribution of 68Ga-Anti-PSMA mAbs(NY108)	1 year	Biodistribution of 68Ga-Anti-PSMA mAbs(NY108) evaluated by radioactive uptake values (standardized uptake values, SUVs) in various organs during repeated 68Ga-PET scans will be reported.

Secondary Outcome Measures

Name	Time	Method
Incidence of Treatment-Emergent Adverse Events	1 year	Safety will be assessed by evaluation of incidence of adverse events.

Trial Locations

Locations (1)

Affiliated Hospital of Jiangnan University; 🇨🇳 Wuxi, Jiangsu, China