Phase Ib/II open label, multicenter study to evaluate the efficacy and safety of AK104 (anti-PD-1 and CTLA-4 bispecific antibody) and AK117#AntiCD47 Antibody# combined with or without chemotherapy in advanced malignant tumors
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
130
Shanghai Renji Hospital
Shanghai, China
RECRUITINGNumber of patients with Adverse Events (AEs)
Time frame: Up to approximately 2 years
Objective Response Rate (ORR)
Time frame: Up to approximately 2 years
Disease control rate (DCR)
Time frame: Up to approximately 2 years
Duration of Response (DoR)
Time frame: Up to approximately 2 years
Time to response (TTR)
Time frame: Up to approximately 2 years
Progression free survival (PFS)
Time frame: Up to approximately 2 years
Overall survival (OS)
Time frame: Up to approximately 2 years
Maximum observed concentration (Cmax) of AK117 and AK104
The endpoints for assessment of PK include serum concentrations of AK117 and AK104 at different timepoints after study drug administration.
Time frame: From first dose of study drug to last dose of of study drug
Minimum observed concentration (Cmin) of AK117 and AK104 at steady state
The endpoints for assessment of PK include serum concentrations of AK117 and AK104 at different timepoints after study drug administration.
Time frame: From first dose of study drug to last dose of of study drug
Number of subjects who develop detectable anti-drug antibodies (ADAs)
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IV infusion,Specified dose on specified days
IV infusion,Specified dose on specified days
IV infusion,Specified dose on specified days
IV infusion,Specified dose on specified days
IV infusion,Specified dose on specified days
IV infusion,Specified dose on specified days
The immunogenicity of AK117 and AK104 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