TheranosticTrials.org

Clinical Trial · NCT05203497

Molecular Imaging of HER2 Expression in Breast Cancer Using 99mTc-ZHER2

Overview

The study should evaluate distribution of 99mTc-ZHER2:41071 Affibody molecule in patients with primary HER2-positive and HER2-negative breast cancer The primary objectives are: 1. To assess distribution of 99mTc-ZHER2:41071 in normal tissues and in tumors over time; 2. To evaluate dosimetry of 99mTc-ZHER2:41071; 3. To obtain initial information concerning safety and tolerability of 99mTc-ZHER2:41071 after single intravenous injection: The secondary objectives are: 1\. To compare the tumor imaging data with the data concerning HER2 expression obtained by immunohistochemistry (IHC) and/or fluorescent in situ hybridization (FISH) analysis of biopsy samples.

Sponsor

Tomsk National Research Medical Center of the Russian Academy of Sciences

Phase

Phase 1

Contacts

Vladimir Chernov, MD, Prof. (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT05203497

Drug / Compound

ZHER2:41071

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

Eligibility

Inclusion

  • Serum creatinine: Within Normal Limits
  • White blood cell count: \> 2.0 x 109/L
  • Availability of results from HER2 status previously determined on material from the primary tumor, either
  • Bilirubin =\< 2.0 times Upper Limit of Normal
  • Hematological, liver and renal function test results within the following limits:
  • Volumetrically quantifiable tumour lesions on CT or MRI, with at least one lesion \> 2.0 cm in greatest diameter outside of the liver and kidneys
  • ALT, ALP, AST: =\< 5.0 times Upper Limit of Normal
  • HER2-negative, defined as a DAKO HercepTest™ score of 0 or 1+; or else if 2+ then FISH negative
  • Hemoglobin: \> 80 g/L
  • Subject is capable to undergo the diagnostic investigations to be performed in the study
  • HER2-positive, defined as a DAKO HercepTest™ score of 3+ or FISH positive or
  • Diagnosis of primary breast cancer with possible lymph node metastases
  • Platelets: \> 50.0 x 109/L

Exclusion

  • Ongoing toxicity \> grade 2 from previous standard or investigational therapies, according to US National Cancer Institute's