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

NCT06641219 | Completed Phase 1

• 1 other identifier: [177Lu]Lu-BQ7876
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

The study should evaluate the biological distribution of \[177Lu\]Lu-BQ7876 in patients with prostate cancer. The objective are:

1. 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. 2.To assess the distribution of \[177Lu\]Lu-BQ7876 in normal tissues and tumors at different time points.
3. 3.To evaluate dosimetry of \[177Lu\]Lu-BQ7876.
4. 4.To study the safety and tolerability of the drug \[177Lu\]Lu-BQ7876 after a single injection.

Conditions

Prostate Cancers

Keywords

Prostate-Specific Membrane Antigen; Prostate Cancers; [177Lu]Lu-BQ7876; Radioligand Therapy

Outcome Measures

Primary Outcomes (3)

• [177Lu]Lu-BQ7876 blood сlearance

  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.

  48 hours

• Gamma camera-based whole-body [177Lu]Lu-BQ7876

  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.

  120 hours

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

  \[177Lu\]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.

  120 hours

Secondary Outcomes (4)

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

  48 hours

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

  48 hours

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

  48 hours

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

  48 hours

Study Arms (1)

Prostate cancer

EXPERIMENTAL

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

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

Interventions

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

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

Prostate cancer

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tomsk National Research Medical Center of the Russian Academy of Sciences: lead

Study Sites (1)

TomskNRMC

Tomsk, 634050, Russia

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Vladimir I Chernov, MD, Prof

  Tomsk NRMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: October 11, 2024
• First Posted: October 15, 2024
• Study Start: October 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: February 28, 2025
• Last Updated: April 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Proposals may be submitted up to 36 months following publication of the results of the trial. After 36 months, the data will be available in the Center's data ware house but without investigator support other than deposited metadata.
• Access Criteria: Information regarding submitting proposals and accessing data may be requested from the principal investigator by e-mail.

Locations

RU (1)