MelanomaPhase 1NCT03050047
A Multicenter Open-Label Single-Arm Multi-Cohort Phase I Study of BCD-100 in Patients With Advanced Solid Tumors
A Phase 1 study testing BCD-100 in people with Melanoma and Lung Cancer, run by Biocad at 4 sites in Russia.
Trial summary
A Multicenter Open-Label Single-Arm Multi-Cohort Phase I Study of Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of BCD-100 (JSC BIOCAD, Russia) in Patients with Advanced Solid Tumors Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma, Lung Cancer, Renal Cell Carcinoma
- What is being tested?
- BCD-100
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 4 sitesRussia
- Study dates
- 30 Aug 2016to Nov 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient provides a written informed consent and is able to follow the requirements of the Protocol;
- Age ≥ 18 years
- Histologically confirmed cancer (well-documented test results; preferably, block specimens available):
- unresectable (stage III/IV) or metastatic (stage IV) melanoma (the drug will be used as the first of subsequent therapy lines);
- Locally advanced or metastatic NSCLC (squamous cell carcinoma/adenocarcinoma), progressive after at least the first-line therapy (the drug will be used as a second or subsequent therapy lines);
- Metastatic clear cell renal carcinoma, progressive after at least the first-line therapy (the drug will be used as a second or subsequent therapy lines);
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- In addition, by investigator's decision, patients with the following malignancies can also be enrolled in the study :
- Pleural mesothelioma progressive after at least one therapy line (the drug will be used as a second or subsequent therapy lines);
- Metastatic bladder cancer progressive after at least one therapy line (the drug will be used as a second or subsequent therapy lines);
- Triple negative breast cancer (ER-, PR-, HER2-) progressive after at least the first-line therapy (the drug will be used as a second or subsequent therapy lines);
- ECOG score of 0 to 2;
- Measurable disease (at least one lesion) according to RECIST v. 1.1 ;
- Resolved toxicity events from the previous therapy or adverse consequences of surgical interventions to ≤ grade 1 CTCAE v. 4.03, except for chronic/irreversible adverse events not affecting the safety of the study therapy (e.g. alopecia);
- No severe pathology of organs or systems;
- Life expectancy of at least 12 weeks from the screening;
- Patients of childbearing potential enrolled in the study must agree to use reliable contraception methods throughout the study period, beginning 2 weeks before the inclusion in the study and up to 8 weeks after the last dose of BCD-100.
Who cannot join
- Severe concomitant illnesses or life-threatening consequences (including pleural/pericardial/peritoneal effusion that requires medical intervention , pulmonary lymphangitis, or involvement of >50% renal parenchyma);
- Brain metastases, progressive or associated with clinical symptoms (e.g. cerebral edema or spinal cord compression). Exclusions: metastases that do not progress and do not require steroids and/or anticonvulsants within at least 4 weeks before randomization ;
- Severe cardiovascular disorders within 6 months before screening;
- Autoimmune diseases;
- Conditions requiring steroids or any other immunosuppressants;
- Blood disorders: ANC ≤1,500/mm3; platelets ≤100,000/mm3; or Hb ≤90 g/L;
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- Renal function impairment: creatinine ≥1.5 × ULN;
- Hepatic function impairment: bilirubin ≥1.5 × ULN; AST and ALT ≥2.5 × ULN (5 × ULN for patients with liver metastases), AlkPh ≥ 5 × ULN;
- Prior anticancer treatment within 28 days before starting the study drug (surgery, radiation therapy , or chemotherapy);
- Known history of more than 6 lines of systemic anticancer chemotherapy (including neoadjuvant and adjuvant CTs);
- Prior treatment with anti-PD1/PDL1 agents or CTLA4 inhibitors;
- Concurrent malignancy except for radically resected cervical carcinoma in situ or radically resected basal cell/squamous cell carcinoma;
- Conditions limiting patient's ability to follow the Protocol requirements (dementia, neurological or psychiatric disorders, drug or alcohol abuse, etc.);
- Simultaneous participation in any other clinical trial; participation in other clinical trials within 30 days before inclusion in the present study; previous participation in the present study.
- Acute infections or active chronic infections;
- Documented HIV infection;
- Positive screening results for Hbs-antigen, hepatitis B core antibodies (anti-HBc Ab) and/or hepatitis C antibodies ;
- Positive results of microprecipitation reaction together with positive TPHA assay results at the screening;
- Body weight > 95 kg.
- Intravenous administration of the drug is impossible;
- Intravenous administration of contrast agents is impossible;
- Hypersensitivity to any component of BCD-100.
- Known history of hypersensitivity to monoclonal antibodies;
- Pregnancy or breastfeeding;
Trial locations and contacts
4 sites in 1 country.
Russia4 sites
"Russian Cancer Research Center named after N.N. Blokhin "of the Ministry of Health of the Russian Federation
Moscow
N.N.Petrov Oncology Research Center
Saint Petersburg, 197758
LLC BioEk
Saint Petersburg
State budgetary health care institution "St. Petersburg Clinical Scientific and Practical Center of Specialized Medical Assistance (Oncological)"
Saint Petersburg
About this study
Official title: A Multicenter Open-Label Single-Arm Multi-Cohort Phase I Study of Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of BCD-100 (JSC BIOCAD, Russia) in Patients With Advanced Solid Tumors
A Multicenter Open-Label Single-Arm Multi-Cohort Phase I Study of Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of BCD-100 (JSC BIOCAD, Russia) in Patients with Advanced Solid Tumors
- Conditions
- Melanoma, Lung Cancer, Renal Cell Carcinoma
- Being tested
- BCD-100
- Medical subject headings
- Melanoma, Lung Neoplasms, Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCD-100Biological
Anti-PD1 monoclonal antibody
| Study group | Role | What they receive |
|---|---|---|
| BCD-100 0.3 mg/kg | Experimental | Patients who receive BCD-100 in a dose of 0.3 mg/kg Receives: Biological: BCD-100 |
| BCD-100 1 mg/kg | Experimental | Patients who receive BCD-100 in a dose of 1 mg/kg Receives: Biological: BCD-100 |
| BCD-100 3 mg/kg | Experimental | Patients who receive BCD-100 in a dose of 3 mg/kg Receives: Biological: BCD-100 |
| BCD-100 10 mg/kg | Experimental | Patients who receive BCD-100 in a dose of 10 mg/kg Receives: Biological: BCD-100 |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR (CR + PR)
Pilot efficacy assessment is not the primary objective of this study and will be conducted by surrogate endpoints describing the direct antitumor effect of the drug.
- ORR (CR + PR) after 85 days of therapy with BCD-100.
Measured: 85 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2017
- Study start30 Aug 2016
- Primary completion1 Jul 2017
- Study completionNov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biocad
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03050047
- Sponsor's protocol ID
- BCD-100-1
- Status last verified
- Aug 2018
- First submitted
- 8 Feb 2017
- Last updated
- 31 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Open-Label Single-Arm Multi-Cohort Phase I Study of Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of BCD-100 (JSC BIOCAD, Russia) in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT03050047
- Acronym / sponsor ID
- BCD-100-1
- Conditions
- Melanoma, Lung Cancer, Renal Cell Carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (actual)
- Lead sponsor
- BiocadIndustry (pharma, biotech, devices)
- Study start
- 30 Aug 2016 (actual)
- Primary completion
- 1 Jul 2017 (actual)
- Study completion
- Nov 2018 (estimated)
- First posted
- 10 Feb 2017 (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.
A Multicenter Open-Label Single-Arm Multi-Cohort Phase I Study of Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of BCD-100 (JSC BIOCAD, Russia) in Patients with Advanced Solid Tumors
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| BCD-100 0.3 mg/kg | Experimental | Biological: BCD-100Patients who receive BCD-100 in a dose of 0.3 mg/kg |
| BCD-100 1 mg/kg | Experimental | Biological: BCD-100Patients who receive BCD-100 in a dose of 1 mg/kg |
| BCD-100 3 mg/kg | Experimental | Biological: BCD-100Patients who receive BCD-100 in a dose of 3 mg/kg |
| BCD-100 10 mg/kg | Experimental | Biological: BCD-100Patients who receive BCD-100 in a dose of 10 mg/kg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Patient provides a written informed consent and is able to follow the requirements of the Protocol;
- Age ≥ 18 years
- Histologically confirmed cancer (well-documented test results; preferably, block specimens available):
- In addition, by investigator's decision, patients with the following malignancies can also be enrolled in the study :
- ECOG score of 0 to 2;
Key exclusion criteria (24 listed)
- Severe concomitant illnesses or life-threatening consequences (including pleural/pericardial/peritoneal effusion that requires medical intervention , pulmonary lymphangitis, or involvement of >50% renal parenchyma);
- Brain metastases, progressive or associated with clinical symptoms (e.g. cerebral edema or spinal cord compression). Exclusions: metastases that do not progress and do not require steroids and/or anticonvulsants within at least 4 weeks before randomization ;
- Severe cardiovascular disorders within 6 months before screening;
- Autoimmune diseases;
- Conditions requiring steroids or any other immunosuppressants;
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-100Anti-PD1 monoclonal antibody | Biological | BCD-100 0.3 mg/kg, BCD-100 1 mg/kg, BCD-100 10 mg/kg, BCD-100 3 mg/kg |
Primary outcome
ORR (CR + PR)
Time frame: 85 days
Pilot efficacy assessment is not the primary objective of this study and will be conducted by surrogate endpoints describing the direct antitumor effect of the drug. • ORR (CR + PR) after 85 days of therapy with BCD-100.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 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-100 in people with Melanoma and Lung Cancer, run by Biocad at 4 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 16 inclusion and 24 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 31 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
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?
ORR (CR + PR) (time frame: 85 days). 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 31 Aug 2018.