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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
BC006 monoclonal antibody injection
Dragonboat Biopharmaceutical,Co.,Ltd
Shanghai, Shanghai Municipality, China
RECRUITINGNumber of Participants Experiencing Dose-limiting Toxicities (DLTs)
Dose Escalation: Phase Ia
Time frame: Up to 28 days
Maximum Tolerated Dose (MTD) of BC006
Dose Escalation: Phase Ia
Time frame: Up to 28 days
Recommended Dose for Expansion (RDE) of BC006
Dose Escalation: Phase Ia
Time frame: Through study completion, an average of 1 year
Number of Participants with TEAEs
Graded according to the NCI CTCAE V5.0
Time frame: Through study completion, an average of 1 year
Number of Participants with SAEs
Graded according to the NCI CTCAE V5.0
Time frame: Through study completion, an average of 1 year
Cmax
Pharmacokinetic parameter, observed Maximum Serum Concentration (Cmax) of BC006
Time frame: From first dose of BC006, an average of 6 months
Tmax
Pharmacokinetic parameter, Time-to-Maximum (Tmax) of BC006
Time frame: 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
Time frame: From first dose of BC006, an average of 6 months
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t1/2
Pharmacokinetic parameters, apparent Terminal Half-life (t1/2) of BC006
Time frame: From first dose of BC006, an average of 6 months
Pharmacodynamic (PD) Parameters
CSF-1 levels in peripheral blood
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: From first dose of BC006, up to 2 years