Clinical Trial · NCT07923786

Clinical Study of 68Ga-labeled Novel EPHA2 Cyclic Peptides PET/CT for Imaging of Solid Tumors

Overview

This study aims to develop novel ⁶⁸Ga-labeled EphA2-targeting cyclic peptide probes for precise diagnosis and patient selection in EphA2-positive cancers.

Sponsor

The First Affiliated Hospital of Soochow University

Phase

Early Phase 1

ClinicalTrials.gov

NCT07923786

Eligibility

Inclusion

c) Hepatic function: Total bilirubin ≤1.5 × ULN; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × ULN; and alkaline phosphatase (ALP) ≤2.5 × ULN.
Hematological parameters, coagulation parameters, and hepatic and renal function must meet the following criteria, without blood transfusion, hematopoietic growth factor support, or hepatoprotective treatment to correct these parameters within 14 days before administration:
d) Renal function: Urea ≤1.5 × ULN; serum creatinine ≤1.5 × ULN; and creatinine clearance ≥50 mL/min, calculated using the Cockcroft-Gault equation.
a) Hematology: White blood cell count (WBC) ≥2.5 × 10⁹/L or absolute neutrophil count (ANC) ≥1.5 × 10⁹/L; platelet count (PLT) ≥100 × 10⁹/L; and hemoglobin ≥90 g/L.
b) Coagulation: Prothrombin time (PT) or activated partial thromboplastin time (aPTT) ≤1.5 × the upper limit of normal (ULN). This criterion applies only to participants not receiving anticoagulation therapy; those receiving anticoagulation therapy must be on a stable anticoagulant dose.
Female participants of childbearing potential must have a negative pregnancy test. Female participants of childbearing potential and male participants of reproductive potential must agree to use effective contraception or abstain from sexual intercourse during the study.

Exclusion

b) Leptomeningeal carcinomatosis;
g) Previous coronary artery bypass grafting;
① Individuals who are unsuitable for or unable to complete PET/CT examinations for any reason, including but not limited to claustrophobia or fear of radiation. ② Individuals unable to tolerate intravenous administration, such as those with a history of fainting in response to needles or blood. ③ Individuals with known hypersensitivity to chimeric or humanized antibodies, fusion proteins, or any other excipients. ④ Individuals with any of the following conditions:
j) Pulmonary embolism;
f) A history of uncontrolled arrhythmia or a current high risk of arrhythmia;
m) A history of immunosuppressive therapy following organ transplantation.
h) A cerebrovascular accident within 6 months before screening;
d) Myocardial infarction within 6 months before screening;
k) Deep vein thrombosis;
c) Poorly controlled diabetes mellitus;
e) Unstable angina;
Individuals with acute or subacute intestinal obstruction or a history of inflammatory bowel disease.
i) Congestive heart failure (New York Heart Association functional class III-IV);
l) An infection requiring intravenous antibiotic treatment within 2 weeks before screening;
Individuals with a history of or a current primary central nervous system tumor.