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

NCT07784660 | Enrolling By Invitation Phase 1

• 1 other identifier: ORI-2026.09.06
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.To assess distribution of \[99mTc\]Tc-DARPinEc1-G3C in normal tissues and in tumors over time;
2. 2.To evaluate dosimetry of \[99mTc\]Tc-DARPinEc1-G3C in breast cancer patients;
3. 3.To obtain initial information concerning safety and tolerability of \[99mTc\]Tc-DARPinEc1-G3C in breast cancer patients after single intravenous injection:

Conditions

Primary Breast Cancer

Keywords

Breast Cancer; EpCAm expression; [99mTc]Tc-DARPinEc1-G3C

Outcome Measures

Primary Outcomes (4)

• Gamma camera-based whole-body [99mTc]Tc-DARPinEc1-G3C uptake value (percent)

  Whole-body \[99mTc\]Tc-DARPinEc1-G3C uptake coinciding with normal organs and tissues will be assessed using gamma camera and calculated as percentage (%) of the injected dose of the radiopharmaceutical.

  6 hours

• SPECT-based [99mTc]Tc-DARPinEc1-G3C uptake value in tumor lesions (counts)

  \[99mTc\]Tc-DARPinEc1-G3C uptake coinciding with tumor lesions will be assessed using single-photon emission computed tomography and measured in counts.

  6 hours

• SPECT-based [99mTc]Tc-DARPinEc1-G3C background uptake value (counts)

  Focal uptake of \[99mTc\]Tc-DARPinEc1-G3C in the regions without pathological findings will be assessed with SPECT and measured in counts

  6 hours

• Tumor-to-background ratio (SPECT)

  The SPECT-based tumor-to-background ratio will be calculated as follows: the value of \[99mTc\]Tc-DARPinEc1-G3C uptake coinciding with tumor lesions (counts) will be divided by the value of \[99mTc\]Tc-DARPinEc1-G3C uptake coinciding with the regions without pathological findings (counts)

  6 hours

Secondary Outcomes (4)

• Percent of cases with abnormal findings based on the assessments of physical examination relative to baseline

  48 hours

• Percent of cases with abnormal findings based on the assessments of vital signs relative to baseline

  48 hours

• Rate of adverse events (percent)

  48 hours

• Rate of administration of concomitant medication (percent)

  48 hours

Study Arms (1)

One single injection of [99mTc]Tc-DARPinEc1-G3C

EXPERIMENTAL

A single injected dose of 3000 µg of \[99mTc\]Tc-DARPinEc1-G3C will be evaluated. The study requires enrollment of at least five (5) evaluable subjects per pathology cohort (Triple negative breast cancer and Luminal breast cancer). Subjects withdrawn from the study for any reason will be replaced.

Drug: [99mTc]Tc-DARPinEc1-G3C

Interventions

[99mTc]Tc-DARPinEc1-G3C DRUG

One single injection of \[99mTc\]Tc-DARPinEc1-G3C, followed by gamma camera imaging directly postinjection and after 2, 4, 6, 24 and 48 hours.

Also known as: SPECT

One single injection of [99mTc]Tc-DARPinEc1-G3C

Eligibility Criteria

• Age: 18 Years - 80 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is \> 18 years of age
• Morphological verification of Breast Cancer T2-4N0-3M0-1
• Negative HER2 expression in primary tumour tissue according ASCO/CAP 2023 recommendation
• ECOG 0-2.
• 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
• Subject is capable to undergo the diagnostic investigations to be performed in the study
• Informed consent

You may not qualify if:

• Refusal from the study
• Any system/local treatment
• Second, non-breast malignancy
• Active current autoimmune/infection disease or history of autoimmune disease. Known HIV positive or chronically active hepatitis B or C
• Administration of other investigational medicinal product within 30 days of screening
• Pregnancy
• Ongoing toxicity \> grade 2 from previous standard or investigational therapies, according to US National Cancer Institute's

Sponsors & Collaborators

• Tomsk National Research Medical Center of the Russian Academy of Sciences: lead

Study Sites (1)

Russia Tomsk NRMC

Tomsk, Tomsk Reg, 634050, Russia

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Vladimir I. Chernov

  Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Diagnostic SPECT for EpCam expression in primary breast tumours

Study Record Dates

• First Submitted: August 20, 2026
• First Posted: August 25, 2026
• Study Start: June 22, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: August 26, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)