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

NCT ID: NCT06641219

Condition: Prostate Cancers

Conditions: Official terms:
Prostatic Neoplasms

Conditions: Keywords:
Prostate-Specific Membrane Antigen
Prostate Cancers
[177Lu]Lu-BQ7876
Radioligand Therapy

Study type: Interventional

Study phase: Phase 1

Overall status: Enrolling by invitation

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Intervention model description: Open-label, exploratory, single centre study. The subjects will receive a single injection of the labeled tracer.

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: One single intravenous injection of [177Lu]Lu-BQ7876
Description: One single intravenous injection of 600-800 MBq [177Lu]Lu-BQ7876 in prostate cancer patients.
Arm group label: Prostate cancer

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.

Criteria for 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

Gender: Male

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Locations:

Facility:
Name: TomskNRMC

Address:
City: Tomsk
Zip: 634050
Country: Russian Federation

Start date: October 1, 2024

Completion date: February 2025

Lead sponsor:
Agency: Tomsk National Research Medical Center of the Russian Academy of Sciences
Agency class: Other

Source: Tomsk National Research Medical Center of the Russian Academy of Sciences

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06641219

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