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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
