TheranosticTrials.org

Clinical Trial · NCT05376644

Molecular Imaging of HER2 Expression in HER2-positive Breast Cancer Using 99mTc-ADAPT6 vs 99mTc-DARPinG3

Overview

An open-label, single center study with 99mTc-ADAPT6 and 99mTc-DARPinG3 SPECT and biopsies of primary tumour in HER2-positive Breast Cancer before system (chemo/targeted) therapy, where the primary endpoint of the study is to compare imaging properties of 99mTc-ADAPT6 and 99mTc-DARPin G3 SPECT in HER2-positive breast cancer patients.

Sponsor

Tomsk National Research Medical Center of the Russian Academy of Sciences

Phase

N/A

Contacts

Olga Bragina, MD, Dsc (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT05376644

Drug / Compound

DARPinG3

Isotope(s):
Target(s):
  • HER2
Ligand Class: Small Proteins and Antibody Fragments
Chelator: HE3-tag

ADAPT6

Isotope(s):
Target(s):
  • HER2
Ligand Class: Small Proteins and Antibody Fragments

Eligibility

Inclusion

  • Availability of results from HER2 status previously determined on material from the primary tumor: HER2-positive, defined as a DAKO HercepTest™ score of 3+ or FISH positive;
  • Sequential injection of 99mTc-ADAPT6 and 99mTc-DARPinG3 in the interval of 3-4 days in each HER2-positive breast cancer patient;
  • Diagnosis of primary breast cancer with possible lymph node metastases before system (chemo+targeted therapy);
  • A negative pregnancy test for all patients of childbearing potential. Sexually active women of childbearing potential participating in the study must use a medically acceptable form of contraception for at least 30 days after study termination;
  • Hemoglobin: \> 80 g/L
  • Bilirubin =\< 2.0 times Upper Limit of Normal
  • White blood cell count: \> 2.0 x 109/L
  • Platelets: \> 50.0 x 109/L
  • Subject is capable to undergo the diagnostic investigations to be performed in the study;
  • ALT, ALP, AST: =\< 5.0 times Upper Limit of Normal
  • Serum creatinine: Within Normal Limits
  • Hematological, liver and renal function test results within the following limits:

Exclusion

  • 1\. Second, non-breast malignancy 2. Active current autoimmune disease or history of autoimmune disease 3. Active infection or history of severe infection within the previous 3 months (if clinically relevant at screening) 4. Known HIV positive or chronically active hepatitis B or C 5. Administration of other investigational medicinal product within 30 days of screening 6. Ongoing toxicity \> grade 2 from previous standard or investigational therapies, according to US National Cancer Institute's\-