Clinical Trial · NCT07784660

Molecular Imaging of EpCam Expression in Breast Cancer Using [99mTc]Tc-DARPinEc1-G3C

Overview

The study should evaluate distribution of \[99mTc\]Tc-DARPinEc1-G3C in patients with primary Triple negative and Luminal breast cancer. The primary objective are: 1. To assess distribution of \[99mTc\]Tc-DARPinEc1-G3C in normal tissues and in tumors over time; 2. To evaluate dosimetry of \[99mTc\]Tc-DARPinEc1-G3C in breast cancer patients; 3. To obtain initial information concerning safety and tolerability of \[99mTc\]Tc-DARPinEc1-G3C in breast cancer patients after single intravenous injection: The secondary objective are: 1\. To compare the tumour imaging data with \[99mTc\]Tc-DARPinEc1-G3C in breast cancer patients with Triple negative and Luminal subtypes.

Sponsor

Tomsk National Research Medical Center of the Russian Academy of Sciences

Phase

Phase 1

Contacts

Vladimir I. Chernov (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT07784660

Drug / Compound

DARPinEc1-G3C

Isotope(s):

Target(s):

EpCAM

Ligand Class: Small Proteins and Antibody Fragments

Eligibility

Inclusion

Negative HER2 expression in primary tumour tissue according ASCO/CAP 2023 recommendation
ECOG 0-2.
Morphological verification of Breast Cancer T2-4N0-3M0-1

Exclusion

Active current autoimmune/infection disease or history of autoimmune disease. Known HIV positive or chronically active hepatitis B or C