Clinical Evaluation of [177Lu]Lu-BQ7876 for Targeting of Prostate-Specific Membrane Antigen
NCT ID: NCT06641219
Last Updated: 2025-04-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
7 participants
INTERVENTIONAL
2024-10-01
2025-02-28
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Prostate cancer
One single intravenous injection of \[177Lu\]Lu-BQ7876
One single intravenous injection of [177Lu]Lu-BQ7876
One single intravenous injection of 600-800 MBq \[177Lu\]Lu-BQ7876 in prostate cancer patients.
Interventions
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One single intravenous injection of [177Lu]Lu-BQ7876
One single intravenous injection of 600-800 MBq \[177Lu\]Lu-BQ7876 in prostate cancer patients.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
75 Years
MALE
No
Sponsors
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Tomsk National Research Medical Center of the Russian Academy of Sciences
OTHER
Responsible Party
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Principal Investigators
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Vladimir I Chernov, MD, Prof
Role: PRINCIPAL_INVESTIGATOR
Tomsk NRMC
Locations
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TomskNRMC
Tomsk, , Russia
Countries
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Other Identifiers
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[177Lu]Lu-BQ7876
Identifier Type: -
Identifier Source: org_study_id
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