Prostate CancersPhase 1NCT06641219
Clinical Evaluation of [177Lu]Lu-BQ7876 for Targeting of Prostate-Specific Membrane Antigen
A Phase 1 study testing One single intravenous injection of [177Lu]Lu-BQ7876 in people with Prostate Cancers, run by Tomsk National Research Medical Center of the Russian Academy of Sciences at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Prostate Cancers
- What is being tested?
- One single intravenous injection of [177Lu]Lu-BQ7876
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteRussia
- Study dates
- 1 Oct 2024to 28 Feb 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of Lutetium-177 Labeled 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:
- 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 assess the distribution of [177Lu]Lu-BQ7876 in normal tissues and tumors at different time points.
- To evaluate dosimetry of [177Lu]Lu-BQ7876.
- To study the safety and tolerability of the drug [177Lu]Lu-BQ7876 after a single injection.
Read the 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:
- 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.
- Conditions
- Prostate Cancers
- Being tested
- One single intravenous injection of [177Lu]Lu-BQ7876
- Keywords
- Prostate-Specific Membrane Antigen, Prostate Cancers, [177Lu]Lu-BQ7876, Radioligand Therapy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One single intravenous injection of [177Lu]Lu-BQ7876Drug
One single intravenous injection of 600-800 MBq [177Lu]Lu-BQ7876 in prostate cancer patients.
| Study group | Role | What they receive |
|---|---|---|
| Prostate cancer | Experimental | One single intravenous injection of [177Lu]Lu-BQ7876 Receives: Drug: One single intravenous injection of [177Lu]Lu-BQ7876 |
What is being measured
The primary outcome is the main question the study is designed to answer.
[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.
Measured: 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.
Measured: 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.
Measured: 120 hours
Secondary outcomes (4)
Percent of cases with abnormal findings relative to baseline [Safety and Tolerability]
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)
Measured: 48 hours
Percent of participants with abnormal laboratory values that are related to [177Lu]Lu-BQ7876 injection [Safety and Tolerability]
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)
Measured: 48 hours
Percent of participants with adverse events that are related to [177Lu]Lu-BQ7876 injection [Safety and Tolerability]
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)
Measured: 48 hours
Percent of participants requiring administration of medication due to side effects that are related to [177Lu]Lu-BQ7876 injection [Safety and Tolerability]
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)
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start1 Oct 2024
- Primary completion1 Dec 2024
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open-label, exploratory, single centre study. The subjects will receive a single injection of the labeled tracer.
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tomsk National Research Medical Center of the Russian Academy of Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vladimir I Chernov, MD, Prof, Principal investigator, Tomsk NRMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06641219
- Sponsor's protocol ID
- ORI-15
- Status last verified
- Jun 2026
- First submitted
- 11 Oct 2024
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual participant data (text, tables, figures, and appendices), underlying the results of the trial, will be shared with researchers to achieve the aims in the approved proposal
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Lutetium-177 Labeled BQ7876 for Targeting of Prostate-Specific Membrane Antigen
- ClinicalTrials.gov ID
- NCT06641219
- Acronym / sponsor ID
- ORI-15
- Conditions
- Prostate Cancers
- Keywords
- Prostate-Specific Membrane Antigen, Prostate Cancers, [177Lu]Lu-BQ7876, Radioligand Therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Tomsk National Research Medical Center of the Russian Academy of SciencesUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study should evaluate the biological distribution of [177Lu]Lu-BQ7876 in patients with prostate cancer.
The objective are:
- 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 assess the distribution of [177Lu]Lu-BQ7876 in normal tissues and tumors at different time points.
- To evaluate dosimetry of [177Lu]Lu-BQ7876.
- 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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open-label, exploratory, single centre study. The subjects will receive a single injection of the labeled tracer.
| Arm | Type | Receives |
|---|---|---|
| Prostate cancer | Experimental | Drug: One single intravenous injection of [177Lu]Lu-BQ7876One single intravenous injection of [177Lu]Lu-BQ7876 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| One single intravenous injection of [177Lu]Lu-BQ7876One single intravenous injection of 600-800 MBq [177Lu]Lu-BQ7876 in prostate cancer patients. | Drug | Prostate cancer |
Primary outcome
[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.
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.
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.
4 secondary outcomes
Percent of cases with abnormal findings relative to baseline [Safety and Tolerability]
Time frame: 48 hours
Percent of participants with abnormal laboratory values that are related to [177Lu]Lu-BQ7876 injection [Safety and Tolerability]
Time frame: 48 hours
Percent of participants with adverse events that are related to [177Lu]Lu-BQ7876 injection [Safety and Tolerability]
Time frame: 48 hours
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- Individual participant dataSharing planned: Yes. Deidentified individual participant data (text, tables, figures, and appendices), underlying the results of the trial, will be shared with researchers to achieve the aims in the approved proposal
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vladimir I Chernov, MD, Prof principal investigator
Tomsk NRMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing One single intravenous injection of [177Lu]Lu-BQ7876 in people with Prostate Cancers, run by Tomsk National Research Medical Center of the Russian Academy of Sciences at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
[177Lu]Lu-BQ7876 blood сlearance (time frame: 48 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.