Clinical trial NCT06641219: Clinical Evaluation of [177Lu]Lu-BQ7876 for Targeting of Prostate-Specific Membrane Antigen
Official title: Clinical Evaluation of Lutetium-177 Labeled BQ7876 for Targeting of Prostate-Specific Membrane Antigen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Prostate Cancers
Keywords: Prostate-Specific Membrane Antigen
Prostate Cancers
[177Lu]Lu-BQ7876
Radioligand Therapy
Lead sponsor: Tomsk National Research Medical Center of the Russian Academy of Sciences
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 7
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open-label, exploratory, single centre study. The subjects will receive a single injection of the labeled tracer.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: [177Lu]Lu-BQ7876 blood сlearance
timeFrame: 48 hours
measure: Gamma camera-based whole-body [177Lu]Lu-BQ7876
timeFrame: 120 hours
measure: SPECT/CT-based [177Lu]Lu-BQ7876 uptake in tumor lesions (SUVmean)
timeFrame: 120 hours
Secondary outcomes:
measure: Percent of cases with abnormal findings relative to baseline [Safety and Tolerability]
timeFrame: 48 hours
measure: Percent of participants with abnormal laboratory values that are related to [177Lu]Lu-BQ7876 injection [Safety and Tolerability]
timeFrame: 48 hours
measure: Percent of participants with adverse events that are related to [177Lu]Lu-BQ7876 injection [Safety and Tolerability]
timeFrame: 48 hours
measure: Percent of participants requiring administration of medication due to side effects that are related to [177Lu]Lu-BQ7876 injection [Safety and Tolerability]
timeFrame: 48 hours
Other outcomes:
Locations:
city: Tomsk
country: Russian Federation
facility: TomskNRMC
Study officials:
affiliation: Tomsk NRMC
name: Vladimir I Chernov, MD, Prof
role: PRINCIPAL_INVESTIGATOR
References: