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

Tomsk National Research Medical Center of the Russian Academy of Sciences7 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Eligibility

Sex: MALEMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

[177Lu]Lu-BQ7876 blood сlearance

Measurement of \[177Lu\]Lu-BQ7876 activity in patient blood samples at various time points: after 5, 10, 20, 40, 60 and 90 minutes, 2, 3, 24, 48 hours.

Time frame: 48 hours

Gamma camera-based whole-body [177Lu]Lu-BQ7876

Whole-body \[177Lu\]Lu-BQ7876 uptake coinciding with normal organs and tissues will be assessed using gamma camera and calculated as percentage (%) of the injected dose of the radiopharmaceutical at 1, 4, 24, 48, 72, 120 hours after single injection.

Time frame: 120 hours

SPECT/CT-based [177Lu]Lu-BQ7876 uptake in tumor lesions (SUVmean)

\[177Lu\]Lu-BQ7876 uptake (SUVmean) with tumor lesions will be assessed using single-photon emission computed tomography and measured in SUVmean after 4, 48, 72 and 120 hours after single injection of radiopharmaceutical.

Time frame: 120 hours

Secondary Outcomes

Percent of cases with abnormal findings relative to baseline [Safety and Tolerability]

The safety attributable to \[177Lu\]Lu-BQ7876 injections will be evaluated based on the assessments of physical examination, vital signs, and ECG (percent of cases with abnormal findings relative to baseline)

Time frame: 48 hours

Percent of participants with abnormal laboratory values that are related to [177Lu]Lu-BQ7876 injection [Safety and Tolerability]

The safety attributable to \[177Lu\]Lu-BQ7876 injections will be evaluated based on the blood and urine laboratory tests (percent of cases with abnormal findings relative to baseline)

Time frame: 48 hours

Percent of participants with adverse events that are related to [177Lu]Lu-BQ7876 injection [Safety and Tolerability]

The safety attributable to \[177Lu\]Lu-BQ7876 injections will be evaluated based on the rate of adverse events(percent of cases with abnormal findings relative to baseline)

Time frame: 48 hours

Percent of participants requiring administration of medication due to side effects that are related to [177Lu]Lu-BQ7876 injection [Safety and Tolerability]

The safety attributable to \[177Lu\]Lu-BQ7876 injections will be evaluated based on the rate of administration of concomitant medication (percent of cases with abnormal findings relative to baseline)

Time frame: 48 hours

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes