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Completed NCT06641219

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

Conditions: Prostate Cancers

Sex: Male
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: PHASE1
Enrollment: 7
Sponsor: Tomsk National Research Medical Center of the Russian Academy of Sciences

Location: TomskNRMC Tomsk

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.

Eligibility Criteria

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

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06641219). StuddyBuddy aggregates publicly available trial information.