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