NCT06641219

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Tomsk National Research Medical Center of the Russian Academy of Sciences · Academic / Other
• Sex: Male
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Cancers

Interventions

Type	Name	Description
DRUG	One single intravenous injection of [177Lu]Lu-BQ7876	One single intravenous injection of 600-800 MBq \[177Lu\]Lu-BQ7876 in prostate cancer patients.

Timeline

• Start date: 2024-10-01
• Primary completion: 2024-12-01
• Completion: 2025-02-28
• First posted: 2024-10-15
• Last updated: 2025-04-09

Locations

1 site across 1 country: Russia