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Clinical Evaluation of [177Lu]Lu-BQ7876 for Targeting of Prostate-Specific Membrane Antigen | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Clinical Evaluation of [177Lu]Lu-BQ7876 for Targeting of Prostate-Specific Membrane Antigen

Clinical Evaluation of Lutetium-177 Labeled BQ7876 for Targeting of Prostate-Specific Membrane Antigen

NCT06641219•Tomsk National Research Medical Center of the Russian Academy of Sciences

View on ClinicalTrials.gov

Summary

The study should evaluate the biological distribution of \[177Lu\]Lu-BQ7876 in patients with prostate cancer. The objective are: 1. To evaluate the content of \[177Lu\]Lu-BQ7876 in the blood of patients with prostate cancer at different time points after a single intravenous administration. 2. To assess the distribution of \[177Lu\]Lu-BQ7876 in normal tissues and tumors at different time points. 3. To evaluate dosimetry of \[177Lu\]Lu-BQ7876. 4. To study the safety and tolerability of the drug \[177Lu\]Lu-BQ7876 after a single injection.

Detailed Description

The overall goal is to study the effectiveness of prostate-specific membrane antigen targeting using Lutetium-177 - labeled BQ7876. Phase I of the study: Biodistribution, dosimetry, safety and tolerability of \[177Lu\]Lu-BQ7876 in patients with prostate cancer. The main objectives of the study: 1. To evaluate the content of \[177Lu\]Lu-BQ7876 in the blood of patients with prostate cancer at different time points after a single intravenous administration. 2. To evaluate the distribution of \[177Lu\]Lu-BQ7876 in normal tissues and tumors in patients with prostate cancer at different time points after a single intravenous administration. 3. To evaluate dosimetry of \[177Lu\]Lu-BQ7876 based on the pharmacokinetic parameters of the drug after a single intravenous administration. 4. To study the safety of use and tolerability of the drug \[177Lu\]Lu-BQ7876 after a single intravenous administration in a diagnostic dosage. Methodology: Open-label, exploratory, single centre study. The subjects will receive a single injection of the labeled tracer.

Eligibility

Age

18 - 75 years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•Subject is \> 18 years of age
•Clinical and radiological diagnosis of prostate cancer 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
•Subject is capable to undergo the diagnostic investigations to be performed in the study
•Informed consent

Exclusion Criteria

•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

Locations (1)

TomskNRMC

Tomsk, Russia

Key Dates

Start Date

October 1, 2024

Primary Completion Date

December 1, 2024

Completion Date

February 28, 2025

Last Updated

April 9, 2025

Enrollment

ACTUAL participants

Conditions

Prostate Cancers

Interventions

One single intravenous injection of [177Lu]Lu-BQ7876

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 9, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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