NeuroblastomaPhase 1NCT05782959
Phase 1 Study of BCD-245 in Subjects With Neuroblastoma
A Phase 1 study testing BCD-245 in people with Neuroblastoma, run by Biocad at 3 sites in Russia.
Trial summary
The aim of the study is to investigate the safety, pharmacokinetics, pharmacodynamics, and immunogenicity of BCD-245 after its single and multiple intravenous infusions at escalating doses in subjects with relapsed/refractory neuroblastoma. Read more about this study
- Who is it for?
- Ages 3 years and older
- Conditions the study is for
- Neuroblastoma
- What is being tested?
- BCD-245
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 3 sitesRussia
- Study dates
- 29 Nov 2021to Jun 2023
- 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 3 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age 3 years and older (12 years and older for the first four subjects) at the time of signing the informed consent form
- Established diagnosis of neuroblastoma (confirmed by the study site laboratory where the subject will be treated) based on: a) histological examination of the tumor tissue (with or without immunohistochemistry) or b) presence of typical tumor agglomerates in the bone marrow and/or meta-iodobenzylguanidine-accumulating focus (foci) and an increase in the level of catecholamine metabolites in serum and/or urine
- Relapsed or refractory neuroblastoma resistant to the anti-relapse therapy adopted at the study site
- Satisfactory performance status (>70 on the Lansky or Karnofsky scale)
- Life expectancy >8 weeks
Who cannot join
- Indications for radiation therapy, surgical intervention for the primary disease at screening
- Isolated CNS relapse of neuroblastoma
- Planned use of any anticancer drugs concomitantly with BCD-245 in this clinical trial
- The need for continuous use of anticonvulsants
- Clinically significant neurological deficit or grade >2 peripheral neuropathy (CTCAE 5.0)
- The need or probable need for systemic continuous use of glucocorticosteroids or other immunosuppressive drugs
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- Signs of respiratory distress (dyspnea at rest and oxygen saturation <94% without oxygen supplementation)
- Any severe organ dysfunction (> CTCAE 5.0 severity grade 2) at screening, except for hematological abnormalities.
- Body weight less than 10 kg.
- Subject receiving anti-GD2 monoclonal antibody therapy within 6 weeks or less prior to intended study drug infusion
Trial locations and contacts
3 sites in 1 country.
Russia3 sites, 3 recruiting
- Recruiting
Dmitry Rogachev National Medical Research Center Of Pediatric Hematology, Oncology and Immunology
Moscow
Mikhail A Maschan, +7 495 287 65 70, info@fnkc.ru
- Recruiting
Russian Cancer Research Center named after N.N. Blokhin "of the Ministry of Health of the Russian Federation
Moscow
Svetlana R Varfolomeev, +7 (499) 324-24-24, info@ronc.ru
- Recruiting
Raisa Gorbacheva Memorial Research Institute of Children Oncology, Hematology and Transplantation
Saint Petersburg
Ludmila S Zubarovskaya, +7(812) 338 6265, bmt-director@1spbgmu.ru
About this study
Official title: An Open-Label, Dose-Escalation, Non-comparative Clinical Study of the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of BCD-245 (JSC BIOCAD, Russia) Administered Intravenously to Subjects With Neuroblastoma
The aim of the study is to investigate the safety, pharmacokinetics, pharmacodynamics, and immunogenicity of BCD-245 after its single and multiple intravenous infusions at escalating doses in subjects with relapsed/refractory neuroblastoma.
Read the detailed description
The study includes 2 stages: 1) Data collection and safety analysis for the first four subjects 12 years of age and older from Cohort 1 2) Data collection and analysis of safety, pharmacokinetics, pharmacodynamics and immunogenicity in all cohorts (Cohorts 1-4).
The design of this Phase I study is based on standard 3 + 3 design approaches. Cohort 1 includes 4 subjects aged 12 years old and older, and 2 subjects aged 3 years old and older. Cohorts 2-4 include 3-6 subjects aged 3 years and older.
- Conditions
- Neuroblastoma
- Being tested
- BCD-245
- Medical subject headings
- Neuroblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCD-245Biological
BCD-245 is administered as prolonged intravenous infusions during each cycle
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | BCD-245 (anti-GD-2 monoclonal antibody), dose 1 Receives: Biological: BCD-245 |
| Cohort 2 | Experimental | BCD-245 (anti-GD-2 monoclonal antibody), dose 2 Receives: Biological: BCD-245 |
| Cohort 3 | Experimental | BCD-245 (anti-GD-2 monoclonal antibody), dose 3 Receives: Biological: BCD-245 |
| Cohort 4 | Experimental | BCD-245 (anti-GD-2 monoclonal antibody), dose 4 Receives: Biological: BCD-245 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects with adverse reactions
Measured: 52 weeks
Proportion of subjects with serious adverse reactions
Measured: 52 weeks
Proportion of subjects with adverse reactions of grade 3 or higher according to CTCAE 5.0
Measured: 52 weeks
Proportion of therapy discontinuations due to adverse reactions
Measured: up to 4 weeks
Secondary outcomes (11)
Area under the plasma concentration versus time curve from time zero to t (AUC 0-t)
Measured: up to 4 weeks
Area under the plasma concentration versus time curve from zero to time infinity (AUC 0-∞)
Measured: up to 4 weeks
Peak plasma concentration (Cmax)
Measured: up to 4 weeks
Time of peak plasma concentration (Tmax)
Measured: up to 4 weeks
Half-life (T1/2)
Half-life is the time taken to decrease the plasma concentration of a drug to one-half its original value
Measured: up to 4 weeks
Volume of distribution (Vd)
Measured: up to 4 weeks
Mean steady-state peak plasma concentration (Cmax)
Measured: 20 weeks
Pre-dose trough concentration (Ctrough)
Measured: 20 weeks
Counts of lymphocytes and CD56+CD16+ (cytokine-secreting and cytotoxic) NK cells
Measured: 52 weeks
Whole blood cytolytic activity test
Measured: 52 weeks
Proportion of subjects with anti-BCD-245 BAbs and NAbs
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2023
- Study start29 Nov 2021
- Primary completionJun 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeuroblastomaStudies of the same condition, open and under way.
- More trials run by BiocadThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biocad
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05782959
- Sponsor's protocol ID
- BCD-245-1
- Status last verified
- Feb 2023
- First submitted
- 16 Feb 2023
- Last updated
- 24 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Dose-Escalation, Non-comparative Clinical Study of the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of BCD-245 (JSC BIOCAD, Russia) Administered Intravenously to Subjects With Neuroblastoma
- ClinicalTrials.gov ID
- NCT05782959
- Acronym / sponsor ID
- BCD-245-1
- Conditions
- Neuroblastoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- BiocadIndustry (pharma, biotech, devices)
- Study start
- 29 Nov 2021 (actual)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 24 Mar 2023 (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 aim of the study is to investigate the safety, pharmacokinetics, pharmacodynamics, and immunogenicity of BCD-245 after its single and multiple intravenous infusions at escalating doses in subjects with relapsed/refractory neuroblastoma.
Detailed description
The study includes 2 stages: 1) Data collection and safety analysis for the first four subjects 12 years of age and older from Cohort 1 2) Data collection and analysis of safety, pharmacokinetics, pharmacodynamics and immunogenicity in all cohorts (Cohorts 1-4).
The design of this Phase I study is based on standard 3 + 3 design approaches. Cohort 1 includes 4 subjects aged 12 years old and older, and 2 subjects aged 3 years old and older. Cohorts 2-4 include 3-6 subjects aged 3 years and older.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Biological: BCD-245BCD-245 (anti-GD-2 monoclonal antibody), dose 1 |
| Cohort 2 | Experimental | Biological: BCD-245BCD-245 (anti-GD-2 monoclonal antibody), dose 2 |
| Cohort 3 | Experimental | Biological: BCD-245BCD-245 (anti-GD-2 monoclonal antibody), dose 3 |
| Cohort 4 | Experimental | Biological: BCD-245BCD-245 (anti-GD-2 monoclonal antibody), dose 4 |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Age 3 years and older (12 years and older for the first four subjects) at the time of signing the informed consent form
- Established diagnosis of neuroblastoma (confirmed by the study site laboratory where the subject will be treated) based on: a) histological examination of the tumor tissue (with or without immunohistochemistry) or b) presence of typical tumor agglomerates in the bone marrow and/or meta-iodobenzylguanidine-accumulating focus (foci) and an increase in the level of catecholamine metabolites in serum and/or urine
- Relapsed or refractory neuroblastoma resistant to the anti-relapse therapy adopted at the study site
- Satisfactory performance status (>70 on the Lansky or Karnofsky scale)
- Life expectancy >8 weeks
Key exclusion criteria (10 listed)
- Indications for radiation therapy, surgical intervention for the primary disease at screening
- Isolated CNS relapse of neuroblastoma
- Planned use of any anticancer drugs concomitantly with BCD-245 in this clinical trial
- The need for continuous use of anticonvulsants
- Clinically significant neurological deficit or grade >2 peripheral neuropathy (CTCAE 5.0)
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 |
|---|---|---|
| BCD-245BCD-245 is administered as prolonged intravenous infusions during each cycle | Biological | Cohort 1, Cohort 2, Cohort 3, Cohort 4 |
Primary outcome
Proportion of subjects with adverse reactions
Time frame: 52 weeks
Proportion of subjects with serious adverse reactions
Time frame: 52 weeks
Proportion of subjects with adverse reactions of grade 3 or higher according to CTCAE 5.0
Time frame: 52 weeks
Proportion of therapy discontinuations due to adverse reactions
Time frame: up to 4 weeks
11 secondary outcomes
Area under the plasma concentration versus time curve from time zero to t (AUC 0-t)
Time frame: up to 4 weeks
Area under the plasma concentration versus time curve from zero to time infinity (AUC 0-∞)
Time frame: up to 4 weeks
Peak plasma concentration (Cmax)
Time frame: up to 4 weeks
Time of peak plasma concentration (Tmax)
Time frame: up to 4 weeks
Half-life (T1/2)
Time frame: up to 4 weeks
Volume of distribution (Vd)
Time frame: up to 4 weeks
Mean steady-state peak plasma concentration (Cmax)
Time frame: 20 weeks
Pre-dose trough concentration (Ctrough)
Time frame: 20 weeks
Counts of lymphocytes and CD56+CD16+ (cytokine-secreting and cytotoxic) NK cells
Time frame: 52 weeks
Whole blood cytolytic activity test
Time frame: 52 weeks
Proportion of subjects with anti-BCD-245 BAbs and NAbs
Time frame: 52 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2023.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BCD-245 in people with Neuroblastoma, run by Biocad at 3 sites 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 5 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 24 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maria Morozova (+7 (495) 992 66 28 ext. 8436, morozovama@biocad.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects with adverse reactions (time frame: 52 weeks). The study lists 4 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 24 Mar 2023.