This is a phase Ib/II study to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of AK119 and AK112 With or Without Chemotherapy for NSCLC patients.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
114
AK119 IV every 3 weeks.
AK112 IV every 3 weeks.
Pemetrexed IV every 3 weeks.
Guangdong Provincial People's Hospital
Guangzhou, China
RECRUITINGNumber of subjects with dose limiting toxicities (DLTs)
DLTs will be assessed during the first 3 weeks of treatment. DLTs 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 DLT observation period.
Time frame: During the first 3 weeks
Number of subjects with adverse events (AEs)
AE refers to any untoward medical occurrence or deterioration of existing medical event after the subject signed the ICF, whether or not considered related to the study treatment.
Time frame: From the time of informed consent signed through 90 days after the last dose of study drug
Objective response rate (ORR)
ORR is defined as the proportion of subjects with confirmed CR or confirmed PR.
Time frame: Up to 2 years
Progression-free survival (PFS)
PFS is defined as the time from the start of treatment until the first documentation of disease progression or death due to any cause, whichever occurs first (based on RECIST Version 1.1).
Time frame: Up to 2 years
Disease control rate (DCR)
DCR is defined as the proportion of subjects with CR, PR, or SD (based on RECIST Version 1.1).
Time frame: Up to 2 years
Duration of response (DoR)
DoR is defined as the duration from the first documentation of objective response to the first documented disease progression (based on RECIST Version 1.1) or death due to any cause, whichever occurs first.
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Carboplatin IV every 3 weeks.
Time frame: Up to 2 years
Time to response (TTR)
TTR is defined as the time from the start of the treatment to the first objective tumor response observed for patients who achieved CR or PR (based on RECIST Version 1.1).
Time frame: Up to 2 years
Overall survival (OS)
OS defined as the time from the first dose to death from any cause.
Time frame: Up to 2 years
Maximum observed concentration (Cmax) of AK119 and AK112
The PK parameters include serum concentrations of AK119 and AK112 at different timepoints after study drug administration.
Time frame: From first dose of study drug through last dose
Number of subjects who develop detectable anti-drug antibodies (ADAs)
The immunogenicity of AK119 and AK112 will be assessed by summarizing the number of subjects who develop detectable antidrug antibodies (ADAs).
Time frame: From first dose of study drug through last dose