Prostate Cancers
Conditions
Keywords
Prostate-Specific Membrane Antigen, Prostate Cancers, [177Lu]Lu-BQ7876, Radioligand Therapy
Brief 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.
Interventions
DRUGOne single intravenous injection of [177Lu]Lu-BQ7876
One single intravenous injection of 600-800 MBq \[177Lu\]Lu-BQ7876 in prostate cancer patients.
Sponsors
Tomsk National Research Medical Center of the Russian Academy of Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open-label, exploratory, single centre study. The subjects will receive a single injection of the labeled tracer.
Eligibility
Sex/Gender
MALE
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| [177Lu]Lu-BQ7876 blood сlearance | 48 hours | 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. |
| Gamma camera-based whole-body [177Lu]Lu-BQ7876 | 120 hours | 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. |
| SPECT/CT-based [177Lu]Lu-BQ7876 uptake in tumor lesions (SUVmean) | 120 hours | \[177Lu\]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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent of cases with abnormal findings relative to baseline [Safety and Tolerability] | 48 hours | 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) |
| Percent of participants with abnormal laboratory values that are related to [177Lu]Lu-BQ7876 injection [Safety and Tolerability] | 48 hours | 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) |
| Percent of participants with adverse events that are related to [177Lu]Lu-BQ7876 injection [Safety and Tolerability] | 48 hours | 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) |
| Percent of participants requiring administration of medication due to side effects that are related to [177Lu]Lu-BQ7876 injection [Safety and Tolerability] | 48 hours | 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) |
Countries
Russia
Contacts
PRINCIPAL_INVESTIGATORVladimir I Chernov, MD, Prof
Tomsk NRMC
Outcome results
None listed