Clinical Trial · NCT05623891

Safety Study of 177Lu-Anti-ED-B mAbs SPECT Imaging in Patients With ED-B Positive Solid Tumors

Overview

This is a single arm study to evaluate the safety and biodistribution of 177Lu-labeled anti-ED-B mAbs SPECT imaging in patients with ED-B positive solid tumors.

Sponsor

Affiliated Hospital of Jiangnan University

Phase

Early Phase 1

Contacts

Chunjing Yu (CONTACT)

ycj_wxd1978@163.com

15312238622

ClinicalTrials.gov

NCT05623891

Drug / Compound

B5-IgG4

Isotope(s):

Target(s):

Extradomain B fibronectin (EDB-FN)

Ligand Class: Antibodies

Eligibility

Inclusion

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

Exclusion

Inadequate control of arrhythmias, including atrial fibrillation;
Patients with abnormal immune function or who have recently used immunosuppressive or potentiating agents including various vaccines;