Molecular Imaging of EpCAM Receptors Using [99mTc]Tc(CO)3-(HE)3-Ec1

NCT05620472 | Completed Phase 1

• 1 other identifier: ORI-18
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The study should evaluate the biological distribution of \[99mTc\]Tc(CO)3-(HE)3-Ec1 in patients with solid tumor The primary objective are:

1. 1.To assess the distribution of \[99mTc\]Tc(CO)3-(HE)3-Ec1 in normal tissues and tumors at different time intervals.
2. 2.To evaluate dosimetry of \[99mTc\]Tc(CO)3-(HE)3-Ec1 .
3. 3.To study the safety and tolerability of the drug \[99mTc\]Tc(CO)3-(HE)3-Ec1 after a single injection in a diagnostic dosage.

Conditions

Solid Tumor, Adult

Keywords

Solid tumor; EpCAM receptors; [99mTc]Tc(CO)3-(HE)3-Ec1; SPECT

Outcome Measures

Primary Outcomes (4)

• Gamma camera-based whole-body [99mTc]Tc(CO)3-(HE)3-Ec1 uptake value (%)

  Whole-body \[99mTc\]Tc(CO)3-(HE)3-Ec1 uptake coinciding with normal organs and tissues will be assessed using gamma camera and calculated as percentage (%) of the injected dose of the radiopharmaceutical

  24 hours

• SPECT-based [99mTc]Tc(CO)3-(HE)3-Ec1 value in tumor lesions (counts)

  \[99mTc\]Tc(CO)3-(HE)3-Ec1 uptake coinciding with tumor lesions will be assessed using single-photon emission computed tomography and measured in counts

  6 hours

• SPECT-based [99mTc]Tc(CO)3-(HE)3-Ec1 uptake value (counts)

  Focal uptake of \[99mTc\]Tc(CO)3-(HE)3-Ec1 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(CO)3-(HE)3-Ec1 uptake coinciding with tumor lesions (counts) will be divided by the value of \[99mTc\]Tc(CO)3-(HE)3-Ec1 uptake coinciding with the regions without pathological findings (counts)

  6 hours

Secondary Outcomes (4)

• Percent of cases with abnormal findings in physical examination, vital signs, and ECG associated with [99mTc]Tc(CO)3-(HE)3-Ec1 injections

  24 hours

• Percent of cases with abnormal laboratory test results associated with [99mTc]Tc(CO)3-(HE)3-Ec1 injections

  24 hours

• Incidence and severity of adverse events associated with [99mTc]Tc(CO)3-(HE)3-Ec1 injections

  24 hours

• Percent of cases requiring administration of concomitant medication due to [99mTc]Tc(CO)3-(HE)3-Ec1 injections

  24 hours

Study Arms (3)

[99mTc]Tc(CO)3-(HE)3-Ec1 1000 μg

EXPERIMENTAL

At least five (5) evaluable subjects with solid tumor.

Drug: Diagnostic Test: whole body study and SPECT with [99mTc]Tc(CO)3-(HE)3-Ec1

[99mTc]Tc(CO)3-(HE)3-Ec1 2000 μg

EXPERIMENTAL

At least five (5) evaluable subjects with solid tumor.

Drug: Diagnostic Test: whole body study and SPECT with [99mTc]Tc(CO)3-(HE)3-Ec1

[99mTc]Tc(CO)3-(HE)3-Ec1 3000 μg

EXPERIMENTAL

At least five (5) evaluable subjects with solid tumor.

Drug: Diagnostic Test: whole body study and SPECT with [99mTc]Tc(CO)3-(HE)3-Ec1

Interventions

Diagnostic Test: whole body study and SPECT with [99mTc]Tc(CO)3-(HE)3-Ec1 DRUG

One single intravenous injection of \[99mTc\]Tc(CO)3-(HE)3-Ec1, followed by gamma camera imaging after 2, 4, 6 and 24 hours.

Also known as: [99mTc]Tc(CO)3-(HE)3-Ec1 SPECT

[99mTc]Tc(CO)3-(HE)3-Ec1 1000 μg; [99mTc]Tc(CO)3-(HE)3-Ec1 2000 μg; [99mTc]Tc(CO)3-(HE)3-Ec1 3000 μg

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is \> 18 years of age
• Clinical and radiological diagnosis of solid tumor with histological verification.
• White blood cell count: \> 2.0 x 10\^9/L
• Haemoglobin: \> 80 g/L
• Platelets: \> 50.0 x 10\^9/L
• Bilirubin =\< 2.0 times Upper Limit of Normal
• Serum creatinine: Within Normal Limits
• Blood glucose level not more than 5.9 mmol/L
• A negative pregnancy test (serum beta-human chorionic gonadotropin, beta-HCG) at screening 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:

• Active current autoimmune disease or history of autoimmune disease
• Active infection or history of severe infection within the previous 3 months (if clinically relevant at screening)
• Known HIV positive or chronically active hepatitis B or C
• Administration of other investigational medicinal product within 30 days of screening
• 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
• Uppsala University: collaborator

Study Sites (1)

TomskNRMC

Tomsk, Russia

Location

Study Officials

• Vladimir I Chernov, MD, Prof

  Cardiology Research Institute, Tomsk National Research Medic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2022
• First Posted: November 17, 2022
• Study Start: October 1, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: June 24, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Three years after completions of the study.
• Access Criteria: Review of requester's application submitted to the Principal Investigator.

Locations

RU (1)