TheranosticTrials.org

Clinical Trial · NCT07023861

The Exploration of Novel Radionuclide-labeled HER2-targeting Antibodies in the Diagnosis of HER2-positive Malignancies

Overview

The purpose of this study is to develop and clinically evaluate 89Zr-labeled HER2-targeted antibodies in diagnosis and screening of HER2-positive cancer patients.

Sponsor

Affiliated Hospital of Jiangnan University

Phase

Early Phase 1

ClinicalTrials.gov

NCT07023861

Drug / Compound

LNCab002

Isotope(s):
Target(s):
  • HER2
Ligand Class: Antibodies
Chelator: DFO

FDG

Isotope(s):
Target(s):
  • Glucose Transport
Ligand Class: Small Molecules

LNCab190

Isotope(s):
Target(s):
  • HER2
Ligand Class: Antibodies
Chelator: DFO

LNCab072

Isotope(s):
Target(s):
  • HER2
Ligand Class: Antibodies
Chelator: DFO

Eligibility

Inclusion

  • Complete blood count, coagulation function and liver and kidney function meet the following criteria (no blood transfusion, no use of hematopoietic stimulating factor drugs and no use of liver protection drugs within 14 days before administration): a) Blood routine: white blood cell count (WBC) ≥ 2.5×109/L or neutrophil count (ANC) ≥1.5×109/L, platelet count (PLT) ≥ 100×109/L, hemoglobin ≥ 90 g/L; b) Coagulation function: prothrombin time (PT) or activated partial thromboplastin time (aPTT) ≤1.5×ULN (limited to patients who are not receiving anticoagulant therapy; Patients receiving anticoagulant therapy should be on a stable dose of anticoagulant); c) Liver function: total bilirubin ≤ 1.5× ULN, ALT/AST ≤ 2.5× ULN, ALP ≤ 2.5×ULN; d) Renal function: urea (UREA) ≤ 1.5×ULN, serum creatinine ≤ 1.5× ULN, creatinine clearance ≥ 50 mL/min (Cockcroft-Gault formula) ;
  • Female subjects of childbearing potential must have a negative pregnancy test ;
  • ECOG score of 0-3 ;
  • Presence of at least one measurable lesion in the subject's body, which can be accurately and continuously measured by the modified RECIST criteria (version 1.1) ;
  • Clinical diagnosed with gastric cancer, breast cancer, urothelial carcinoma, diagnostic criteria refer to biopsy, and HER2 immunohistochemistry result is positive ;
  • Female subjects of childbearing potential as well as male subjects of childbearing potential must agree to use effective contraception or restrict sexual behavior for the duration of the study ;

Exclusion

  • Those who cannot tolerate intravenous administration (such as history of needle sickness and blood sickness) ;
  • Received or planned to receive immune checkpoint blockade therapy, including anti-CTLA-4, anti-PD-1 or anti-PD-L1 therapeutic antibodies, within 1 year prior to screening, prior to completion of the study imaging procedure, etc ;
  • Those with a history of acute or subacute intestinal obstruction, or inflammatory bowel disease ;
  • Known allergy to chimeric or human antibodies or fusion proteins, or other excipients
  • Patients who did not meet the requirements as assessed by the investigator.
  • Presence of active autoimmune disease, or history of autoimmune disease requiring treatment with systemic hormones and/or immunosuppressants, or syndrome requiring systemic steroids or immunosuppressive medications;
  • Those who have had or are currently concomitant with primary central nervous system tumors ;
  • Those who are not suitable for PET/CT examination or cannot complete PET/CT examination for special reasons, including but not limited to claustrophobia, radiophobia, etc ;
  • Toxicity from prior anticancer therapy has not recovered to grade 0 or 1 (CTCAE version 5.0), with the exception of alopecia ;
  • Those who have participated in clinical trials of radiopharmaceuticals within 1 month prior to screening ;
  • Drugs/clinical operators who have been evaluated by the investigator within 1 month prior to screening to affect the uptake of 89Zr-LNCab002, 89Zr-LNCab190 and 89Zr-LNCab072;