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| Name | Class |
|---|---|
| West China Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BC006 | Drug | BC006 monoclonal antibody injection |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Experiencing Dose-limiting Toxicities (DLTs) | Dose Escalation: Phase Ia | Up to 28 days |
| Maximum Tolerated Dose (MTD) of BC006 | Dose Escalation: Phase Ia | Up to 28 days |
| Recommended Dose for Expansion (RDE) of BC006 | Dose Escalation: Phase Ia | Through study completion, an average of 1 year |
| Number of Participants with TEAEs | Graded according to the NCI CTCAE V5.0 | Through study completion, an average of 1 year |
| Number of Participants with SAEs | Graded according to the NCI CTCAE V5.0 | Through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Pharmacokinetic parameter, observed Maximum Serum Concentration (Cmax) of BC006 | From first dose of BC006, an average of 6 months |
| Tmax | Pharmacokinetic parameter, Time-to-Maximum (Tmax) of BC006 |
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Key Inclusion Criteria:
Signed informed consent form.
Age ≥ 18 years.
Clinical diagnosis:
Dose Escalation: Phase Ia
Dose Expansion: Phase Ib
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:
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.
Key Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuan Peng | Contact | #86#021-50276381 | yuan.peng@dragonboatbio.com | |
| Ting Yan | Contact | #86#021-50276381 | ting.yan@dragonboatbio.com |
| Name | Affiliation | Role |
|---|---|---|
| Li Zheng | West China Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dragonboat Biopharmaceutical,Co.,Ltd | Recruiting | Shanghai | Shanghai Municipality | 200000 | China |
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| 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 | From first dose of BC006, an average of 6 months |
| t1/2 | Pharmacokinetic parameters, apparent Terminal Half-life (t1/2) of BC006 | From first dose of BC006, an average of 6 months |
| Pharmacodynamic (PD) Parameters | CSF-1 levels in peripheral blood | 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 | 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 | 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 | 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. | 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. | From first dose of BC006, up to 2 years |