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NCT Number: NCT06641219

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

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.

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Key information

Conditions

Prostate Cancers Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

TomskNRMC

Tomsk, 634050, Russia

About this study

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:

  • 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.
  • 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.
  • To evaluate dosimetry of [177Lu]Lu-BQ7876 based on the pharmacokinetic parameters of the drug after a single intravenous administration.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

One single intravenous injection of [177Lu]Lu-BQ7876

Drug

One single intravenous injection of 600-800 MBq [177Lu]Lu-BQ7876 in prostate cancer patients.

Primary outcomes

  1. [177Lu]Lu-BQ7876 blood сlearance

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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 outcomes

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

    Time frame: 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)

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

    Time frame: 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)

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

    Time frame: 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)

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

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Tomsk National Research Medical Center of the Russian Academy of Sciences

Other

Registry information

Official study title

Clinical Evaluation of Lutetium-177 Labeled BQ7876 for Targeting of Prostate-Specific Membrane Antigen

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Oct 15, 2024
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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