It is a single-arm, open-label, multicenter, phase II study to evaluate the safety, efficacy, pharmacokinetics (PK) and immunogenicity of AK104 as a single agent in subjects with previously-treated locally advanced unresectable or metastatic MSI-H or dMMR solid tumors.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
AK104,6 mg/kg IV,every 2 weeks (Q2W)
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China
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
Duration of response (DoR)
DoR is defined as the duration from the first documentation of objective response to the first documented disease progression or death due to any cause, whichever occurs first.
Time frame: Up to 2 years
Progression-free survival (PFS)
PFS is defined as the time from the start of treatment with AK104 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 AK104 until death due to any cause.
Time frame: Up to 2 years
Adverse events (AEs)
Incidences of treatment-emergent adverse events (TEAEs) , treatment-related adverse events (TRAEs) as assessed by CTCAE v5.0
Time frame: From first dose of AK104 through to 90 days after last dose of AK104
Observed pharmacokinetics (PK) exposure of AK104
The endpoints for assessment of PK of AK104 include serum concentrations of AK104 at different timepoints after AK104 administration.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: From first dose of AK104 through to 90 days after last dose of AK104
Number of subjects who develop detectable anti-drug antibodies (ADAs)
The immunogenicity of AK104 will be assessed by summarizing the number of subjects who develop detectable ADAs.
Time frame: From first dose of AK104 through to 90 days after last dose of AK104