This is a phase Ia/Ib study to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of AK131 in advanced solid tumor patients
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
130
AK131 is an anti-PD-1 and CD73 bispecific antibody
Jinming Yu
Jinan, Shandong, China
RECRUITINGNumber of subjects with dose limiting toxicities (DLTs)
DLTs will be assessed during the first 4 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 4 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
Serum PK concentration of AK131
Serum PK concentration of AK131 in individual subjects at different time points after AK131 administration
Time frame: From first dose of study drug through 30 days after last dose of study drug
Number of subjects who develop detectable anti-drug antibodies (ADAs)
The immunogenicity of AK131 will be assessed by summarizing the number of subjects who develop detectable anti-drug antibodies (ADAs)
Time frame: From first dose of study drug through 30 days after last dose of study drug
Objective response rate (ORR)
ORR is defined as the proportion of subjects with confirmed CR or confirmed PR (based on RECIST Version 1.1).
Time frame: Up to approximately 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).
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Time frame: Up to approximately 2 years
Progression-free survival (PFS)
PFS is defined as the time from the start of treatment until the first documentation of disease progression (based on RECIST Version 1.1) or death due to any cause, whichever occurs first.
Time frame: Up to approximately 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 approximately 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.
Time frame: Up to approximately 2 years
Overall survival (OS)
OS defined as the time from the first dose to death from any cause.
Time frame: Up to approximately 2 years