Clinical Trial · NCT04989010

Safety Study of 89Zr-Anti-CLDN18.2 mAbs PET Imaging in Patients With CLDN18.2 Positive Solid Tumors

Overview

This is a single arm study to evaluate the safety and biodistribution of 89Zr-labeled anti-CLDN18.2 mAbs (89Zr-NY005) PET imaging in patients with CLDN18.2 positive solid tumors.

Sponsor

Sichuan Provincial People's Hospital

Phase

N/A

ClinicalTrials.gov

NCT04989010

Eligibility

Inclusion

ALT, AST shall not exceed 3 times of the normal upper limit; Bun, Cr not exceed 1.5 times of the normal upper limit.
Other routine examinations are within the normal range or considered acceptable by the researchers.
Patients with biopsy-proven CLDN18.2 positive;
ECOG score ≤ 0\~3; Life expectancy of at least 3 months;
At least two measurable solid lesions has been examined by 18F-FDG PET/CT (RECIST1.1 standard);
Patients diagnosed with solid tumors confirmed by histopathology or cytology test;

Exclusion

Recovery from major trauma (including surgery) within 4 weeks prior to study treatment;
Uncontrolled hypertension;
Patients with autoimmune diseases, including rheumatoid arthritis;
Syphilis, HBV, HCV, or HIV positive subjects;
Inadequate control of arrhythmias, including atrial fibrillation;
Patients with a history of mental illness or related conditions;
Patients with abnormal immune function or who have recently used immunosuppressive or potentiating agents including various vaccines;
Pregnant or lactating women;
Other subjects considered unsuitable by researchers.
Patients who cannot undergo PET/CT imaging scan;
Patients with allergies or allergies to any component of the imaging agent or antibody;
Patients with systemic or locally severe infections, or other serious coexisting diseases;