Advanced Solid Tumors (Including GCTTS)Phase 1NCT05212896
An Exploratory Clinical Study of BC006 in Patients With Advanced Solid Tumors
A Phase 1 study testing BC006 in people with Advanced Solid Tumors (Including GCTTS), run by Dragonboat Biopharmaceutical Company Limited at 1 site in China.
Trial summary
This is a first in human, open-label, exploratory phase I clinical study including dose escalation (Ia) and dose expansion (Ib) stage. It aims to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of BC006 in giant cell tumor of tendon sheath (GCTTS) and other advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors (Including GCTTS)
- What is being tested?
- BC006
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 26 Nov 2021to Dec 2024
- 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
- Signed informed consent form.
- Age ≥ 18 years.
- Clinical diagnosis:
- Dose Escalation: Phase Ia
- Histologically or cytologically confirmed GCTTS: initial treatment unresectable, or postoperative recurrence unresectable, or refuse surgical treatment.
- Patients with histologically or cytologically confirmed advanced solid tumor, who have progression after prior SOC therapy, or who intolerant to SOC, or for whom there is no SOC therapy available.
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- Dose Expansion: Phase Ib
- Cohort 1: Histologically or cytologically confirmed GCTTS: initial treatment unresectable, or postoperative recurrence unresectable, or refuse surgical treatment.
- Cohort 2~4: Patients with histologically or cytologically confirmed advanced solid tumor which is sensitive to Ia treatment，who have progression after prior SOC therapy, or who intolerant to SOC, or for whom there is no SOC therapy available.
- Life expectancy ≥ 12 weeks.
- Ia: at least one evaluable lesion; Ib: at least one measureable lesion as defined by RECIST V1.1.
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.
- Evidence of adequate organ function by standard laboratory tests:
- Adequate hematological function: Hemoglobin (Hgb) ≥ 90 g/L, Absolute neutrophil count (ANC) ≥ 1.5 × 109/L, Platelets (Plts) ≥ 90 × 109/L.
- Adequate liver function: Total bilirubin ≤ 1.5 × the upper limit of normal (ULN), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT) ≤ 2.5 × ULN (AST≤ 5 × ULN, ALT≤ 5 × ULN for subjects with liver metastases).
- Adequate renal function: Creatinine ≤ 1.5 × ULN, or Creatinine clearance by Cockcroft Gault formula ≥ 50 mL/min.
- Adequate Coagulation function: Activated partial thrombin time (APTT) ≤ 1.5 × ULN, prothrombin time (PT) ≤ 1.5 × ULN, international standardized ratio (INR) ≤ 1.5 × ULN.
- Female patients of child-bearing potential or male patients with a female partner(s) of child-bearing potential must agree to use reliable contraceptive methods (hormonal, condoms or abstinence) for the duration of the study and for 6 months after the last dose of BC006; women of child-bearing potential must have a negative blood or urine pregnancy test within 7 days prior to enrollment.
Who cannot join
- Prior anti-tumor therapies such as radiotherapy, chemotherapy, targeted therapy, endocrine therapy, immunotherapy or other investigational agents within 4 weeks before the first dose of BC006.
- Prior treatment with any anti-CSF-1R inhibitor.
- Any toxicity from previous anti-tumor treatments have not recovered to CTCAE V5.0 grade ≤ 1 (except treatment-related alopecia).
- Patients with untreated or clinically symptomatic brain metastases, spinal cord compression, cancerous meningitis, or patients with evidence that brain and spinal cord metastases have not been controlled (Patients with previously treated brain metastases may participate provided they are clinically and imaging stable for at least 4 weeks prior to first dose of BC006, have no evidence of cerebral edema and are off steroids).
- Patients with severe cardiovascular diseases: cardiac arrhythmia requiring clinical intervention; acute coronary syndrome, congestive heart failure, stroke or other ≥ grade 3 cardiovascular events within 6 months; New York Heart Association (NYHA) cardiac function ≥ grade II or left ventricular ejection fraction (LVEF) <50%; poorly controlled hypertension as judged by the investigator are not suitable to participate in the study.
- Receipt of a live vaccine within 4 weeks prior to the first dose of BC006 or anticipation that such a live vaccine will be required during the study.
- Patients with symptomatic pleural, abdominal, or pericardial effusions that require repeated puncture and drainage treatment and cannot be relieved; patients with stable disease after receiving treatment (including therapeutic thoracentesis or abdominal puncture) are allowed to enroll.
- In the opinion of the investigator, patients have any clinical or laboratory examination abnormality or other conditions that are not suitable to participate in the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Dragonboat Biopharmaceutical,Co.,Ltd
Shanghai, Shanghai Municipality, 200000
Yuan Peng, #86#021-5027638, yuan.peng@dragonboatbio.com
Ting Yan, #86#021-5027638, ting.yan@dragonboatbio.com
About this study
Official title: An Exploratory Clinical Study to Evaluate the Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of BC006 Monoclonal Antibody Injection in Patients With Advanced Solid Tumors Including Giant Cell Tumor of Tendon Sheath
This is a first in human, open-label, exploratory phase I clinical study including dose escalation (Ia) and dose expansion (Ib) stage. It aims to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of BC006 in giant cell tumor of tendon sheath (GCTTS) and other advanced solid tumors.
- Conditions
- Advanced Solid Tumors (Including GCTTS)
- Being tested
- BC006
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BC006Drug
BC006 monoclonal antibody injection
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation: Phase Ia | Experimental | Participants will receive escalating doses of BC006 at assigned dose (0.08, 0.3, 1.0, 3.0, 10, 20 mg/kg) via intravenous (IV) infusion every 2 weeks until disease progression, unacceptable toxicity, withdrawal of informed consent, or up to 48 weeks of treatment, whichever occurs first. Receives: Drug: BC006 |
| Dose Expansion: Phase Ib Cohort 1 | Experimental | Participants with GCTTS will receive BC006 at recommended dose for expansion (RDE) IV every 2 weeks until disease progression, unacceptable toxicity, withdrawal of informed consent, or up to 24 weeks of treatment, whichever occurs first. Receives: Drug: BC006 |
| Dose Expansion: Phase Ib Cohort 2~4 | Experimental | Participants with other solid tumors will receive BC006 at RDE IV every 2 weeks until disease progression, unacceptable toxicity, withdrawal of informed consent, or up to 48 weeks of treatment, whichever occurs first. Receives: Drug: BC006 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Experiencing Dose-limiting Toxicities (DLTs)
Dose Escalation: Phase Ia
Measured: Up to 28 days
Maximum Tolerated Dose (MTD) of BC006
Dose Escalation: Phase Ia
Measured: Up to 28 days
Recommended Dose for Expansion (RDE) of BC006
Dose Escalation: Phase Ia
Measured: Through study completion, an average of 1 year
Number of Participants with TEAEs
Graded according to the NCI CTCAE V5.0
Measured: Through study completion, an average of 1 year
Number of Participants with SAEs
Graded according to the NCI CTCAE V5.0
Measured: Through study completion, an average of 1 year
Secondary outcomes (10)
Cmax
Pharmacokinetic parameter, observed Maximum Serum Concentration (Cmax) of BC006
Measured: From first dose of BC006, an average of 6 months
Tmax
Pharmacokinetic parameter, Time-to-Maximum (Tmax) of BC006
Measured: From first dose of BC006, an average of 6 months
AUC0-t
Pharmacokinetic parameter, area under the plasma concentration time curve from time 0 to the time of last observed quantifiable concentration (AUC0-t) of BC006
Measured: From first dose of BC006, an average of 6 months
t1/2
Pharmacokinetic parameters, apparent Terminal Half-life (t1/2) of BC006
Measured: From first dose of BC006, an average of 6 months
Pharmacodynamic (PD) Parameters
CSF-1 levels in peripheral blood
Measured: From first dose of BC006, an average of 6 months
Number of Participants with Anti-BC006 Antibodies (ADAs)
ADA titer and Neutralizing Antibodies (NAbs) analysis will be performed when ADA is positive
Measured: From first dose of BC006, an average of 6 months
Objective Response Rate (ORR)
The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR, based on RECIST Version 1.1
Measured: From first dose of BC006, up to 2 years
Disease Control Rate (DCR)
Disease control rate (DCR) is defined as the proportion of the optimal time response of CR, PR, disease stable (SD) (i.e. CR+PR+SD) between initiation of the trial drug and withdrawal from the trial, as assessed according to RECIST Version 1.1
Measured: From first dose of BC006, up to 2 years
Progression-Free Survival (PFS)
Progression-free survival (PFS) is defined as the time elapsed from the day the study drug was first administered until the first imaging assessment of disease progression (PD) or death from any cause.
Measured: From first dose of BC006, up to 2 years
Duration of Response (DOR)
The duration of response (DOR) is defined as the time from the beginning of the first tumor assessment as PR or CR to the first assessment as PD or death from any cause.
Measured: From first dose of BC006, up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2022
- Study start26 Nov 2021
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid Tumors (Including GCTTS)Studies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dragonboat Biopharmaceutical Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- West China Hospital
- Responsible party
- Sponsor
- Investigators
- Li Zheng, Study chair, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05212896
- Sponsor's protocol ID
- BC006-Ⅰ-01
- Status last verified
- Jun 2021
- First submitted
- 4 Jan 2022
- Last updated
- 28 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Clinical Study to Evaluate the Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of BC006 Monoclonal Antibody Injection in Patients With Advanced Solid Tumors Including Giant Cell Tumor of Tendon Sheath
- ClinicalTrials.gov ID
- NCT05212896
- Acronym / sponsor ID
- BC006-Ⅰ-01
- Conditions
- Advanced Solid Tumors (Including GCTTS)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Dragonboat Biopharmaceutical Company LimitedIndustry (pharma, biotech, devices)
- Collaborators
- West China Hospital
- Study start
- 26 Nov 2021 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 28 Jan 2022 (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.
This is a first in human, open-label, exploratory phase I clinical study including dose escalation (Ia) and dose expansion (Ib) stage. It aims to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of BC006 in giant cell tumor of tendon sheath (GCTTS) and other advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation: Phase Ia | Experimental | Drug: BC006Participants will receive escalating doses of BC006 at assigned dose (0.08, 0.3, 1.0, 3.0, 10, 20 mg/kg) via intravenous (IV) infusion every 2 weeks until disease progression, unacceptable toxicity, withdrawal of informed consent, or up to 48 weeks of treatment, whichever occurs first. |
| Dose Expansion: Phase Ib Cohort 1 | Experimental | Drug: BC006Participants with GCTTS will receive BC006 at recommended dose for expansion (RDE) IV every 2 weeks until disease progression, unacceptable toxicity, withdrawal of informed consent, or up to 24 weeks of treatment, whichever occurs first. |
| Dose Expansion: Phase Ib Cohort 2~4 | Experimental | Drug: BC006Participants with other solid tumors will receive BC006 at RDE IV every 2 weeks until disease progression, unacceptable toxicity, withdrawal of informed consent, or up to 48 weeks of treatment, whichever occurs first. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Signed informed consent form.
- Age ≥ 18 years.
- Clinical diagnosis:
- Dose Escalation: Phase Ia
- Dose Expansion: Phase Ib
Key exclusion criteria (8 listed)
- Prior anti-tumor therapies such as radiotherapy, chemotherapy, targeted therapy, endocrine therapy, immunotherapy or other investigational agents within 4 weeks before the first dose of BC006.
- Prior treatment with any anti-CSF-1R inhibitor.
- Any toxicity from previous anti-tumor treatments have not recovered to CTCAE V5.0 grade ≤ 1 (except treatment-related alopecia).
- Patients with untreated or clinically symptomatic brain metastases, spinal cord compression, cancerous meningitis, or patients with evidence that brain and spinal cord metastases have not been controlled (Patients with previously treated brain metastases may participate provided they are clinically and imaging stable for at least 4 weeks prior to first dose of BC006, have no evidence of cerebral edema and are off steroids).
- Patients with severe cardiovascular diseases: cardiac arrhythmia requiring clinical intervention; acute coronary syndrome, congestive heart failure, stroke or other ≥ grade 3 cardiovascular events within 6 months; New York Heart Association (NYHA) cardiac function ≥ grade II or left ventricular ejection fraction (LVEF) <50%; poorly controlled hypertension as judged by the investigator are not suitable to participate in the study.
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 |
|---|---|---|
| BC006BC006 monoclonal antibody injection | Drug | Dose Escalation: Phase Ia, Dose Expansion: Phase Ib Cohort 1, Dose Expansion: Phase Ib Cohort 2~4 |
Primary outcome
Number of Participants Experiencing Dose-limiting Toxicities (DLTs)
Time frame: Up to 28 days
Dose Escalation: Phase Ia
Maximum Tolerated Dose (MTD) of BC006
Time frame: Up to 28 days
Dose Escalation: Phase Ia
Recommended Dose for Expansion (RDE) of BC006
Time frame: Through study completion, an average of 1 year
Dose Escalation: Phase Ia
Number of Participants with TEAEs
Time frame: Through study completion, an average of 1 year
Graded according to the NCI CTCAE V5.0
Number of Participants with SAEs
Time frame: Through study completion, an average of 1 year
Graded according to the NCI CTCAE V5.0
10 secondary outcomes
Cmax
Time frame: From first dose of BC006, an average of 6 months
Tmax
Time frame: From first dose of BC006, an average of 6 months
AUC0-t
Time frame: From first dose of BC006, an average of 6 months
t1/2
Time frame: From first dose of BC006, an average of 6 months
Pharmacodynamic (PD) Parameters
Time frame: From first dose of BC006, an average of 6 months
Number of Participants with Anti-BC006 Antibodies (ADAs)
Time frame: From first dose of BC006, an average of 6 months
Objective Response Rate (ORR)
Time frame: From first dose of BC006, up to 2 years
Disease Control Rate (DCR)
Time frame: From first dose of BC006, up to 2 years
Progression-Free Survival (PFS)
Time frame: From first dose of BC006, up to 2 years
Duration of Response (DOR)
Time frame: From first dose of BC006, up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2022.
- Individual participant dataSharing planned: No
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.
Li Zheng study chair
West China Hospital
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 BC006 in people with Advanced Solid Tumors (Including GCTTS), run by Dragonboat Biopharmaceutical Company Limited at 1 site in China.
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 18 inclusion and 8 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 28 Jan 2022. 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 China. 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 Yuan Peng (#86#021-50276381, yuan.peng@dragonboatbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Experiencing Dose-limiting Toxicities (DLTs) (time frame: Up to 28 days). The study lists 5 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 28 Jan 2022.