This study is a multicenter, open-label, multi-dose, first-in-human (FIH) Phase I/IIa study to determine the safety and tolerability of VBC103, as well as the maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D), PK and further evaluate its efficacy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
255
VBC103
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
RECRUITINGIncidence of dose-limiting toxicities (DLT) as defined in the protocol
Number of patients with at least 1 dose-limiting toxicity (DLT), which is any toxicity defined as a DLT in the Clinical Study Protocol
Time frame: (DLT)From time of first dose of VBC103 to end of DLT period (approximately 21 days)
Incidence of Serious Adverse Events
Number of patients with serious adverse events by system organ class and preferred term
Time frame: From time of Informed Consent to 30 days post last dose of VBC103
Objective Response Rate (ORR)
The percentage or number of patients with a confirmed investigator assessed complete or partial response according to response criteria in solid tumours (RECIST v1.1)
Time frame: From date of first dose of VBC103 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years)
Duration of Response (DOR)
The time from date of first response until date of disease progression or last evaluable assessment (RECIST v1.1) in the absence of progression
Time frame: From date of first dose of VBC103 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years)
Disease Control Rate (DCR) at 12 weeks
The percentage of patients with confirmed CR or PR or having SD maintained (RECIST v1.1) for \>=11 weeks from first dose
Time frame: From date of first dose of VBC103 up until progression, or the last evaluable assessment in the absence of progression (for each patient this is expected to be measured at 12 weeks)
Pharmacokinetics of VBC103: Plasma PK concentrations
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Measurement of plasma concentrations of VBC103, total antibody and total unconjugated warhead
Time frame: From date of first dose of VBC103 up until 30 days post last dose
Pharmacokinetics of VBC103: Maximum plasma concentration of the study drug (C-max)
Measurement of PK parameters: Maximum observed plasma concentration of the study drug (C-max)
Time frame: From date of first dose of VBC103 up until 30 days post last dose
Pharmacokinetics of VBC103: Time to maximum plasma concentration of the study drug (T-max)
Measurement of PK parameters: Time to maximum observed plasma concentration of the study drug (T-max)
Time frame: From date of first dose of VBC103 up until 30 days post last dose
Immunogenicity of VBC103: Anti-Drug Antibodies (ADA)
Evaluating the number and percentage of patients who develop Anti-drug antibody (ADA) during treatment
Time frame: From date of first dose of VBC103 up until 30 days post last dose