This is a first in human(FIH) study to characterize the safety, tolerability, pharmacokinetics (PK), immunogenicity and anti-tumor activity of AK109, an anti-VEGFR2 monoclonal antibody, as a single agent in adult subjects with advanced solid tumor.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
AK109, 2#4#8#12#18mg/kg, IV, every 2 weeks (Q2W), or 15 mg/kg every 3 weeks(Q3W)
The First Affiliated Hospital of Medicine College, Zhejiang University
Hangzhou, Zhejiang, China
Number of subjects experiencing dose-limiting toxicities (DLTs)
DLTs will be assessed during the first 4 weeks of treatment for dose-escalation phase and are defined as toxicities that meet pre-defined severity criteria, and assessed as having a suspected relationship to study drug, and unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first cycle (4 weeks) of treatment.
Time frame: During the first 4 weeks
Adverse events (AEs)
An adverse event (AE) is any untoward medical occurrence or the deterioration of existing medical event in a clinical study subject administered an investigational drug, which does not necessarily have an unequivocal causal relationship with the investigational product. Incidences of treatment-emergent adverse events (TEAEs) , treatment-related adverse events (TRAEs) as assessed by CTCAE v5.0.
Time frame: From the time of informed consent signed through to 60 days after last dose of AK109
Objective response rate (ORR)
ORR is defined as the proportion of subjects with confirmed CR or PR, based on RECIST v1.1.
Time frame: Up to 2 years
Disease control rate (DCR)
DCR is defined as the proportion of subjects with confirmed CR, PR, or SD, based on RECIST v1.1.
Time frame: Up to 2 years
Progression-free survival (PFS)
PFS is defined as the time from the start of treatment with AK109 until the first documentation of disease progression or death due to any cause, whichever occurs first.
Time frame: Up to 2 years
Overall survival (OS)
OS is defined as the time from the start of treatment with AK109 until death due to any cause.
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Time frame: Up to 2 years
Observed pharmacokinetics (PK) exposure of AK109
The endpoints for assessment of PK of AK109 include serum concentrations of AK109 at different timepoints after AK109 administration.
Time frame: From first dose of AK109 through 30 days after last dose of AK109
Number of subjects who develop detectable anti-drug antibodies (ADAs)
The immunogenicity of AK109 will be assessed by summarizing the number of subjects who develop detectable ADAs.
Time frame: From first dose of AK109 through 30 days after last dose of AK109