This is a multicenter, open label, single arm, Phase 1,dose escalation and dose expansion study designed to evaluate the safety, tolerability, pharmacodynamics, PK, immunogenicity, and preliminary antitumor activity of AK117 administered intravenously to adult subjects with relapsed/refractory advanced or metastatic solid tumors or lymphomas.
The study comprises a dose escalation phase and a dose expansion phase. The phases will be conducted sequentially. Approximately 162 subjects will be enrolled in this study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
49
An intravenous (IV) infusion of AK117 as monotherapy. All subjects will receive 4 weekly infusions (Days 1, 8, 15, and 22) of AK117 in each 28-day treatment cycle until unacceptable toxicity, documentation of confirmed progressive disease (PD), or subject withdrawal
FuDan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Number of participants with adverse events (AEs)
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Time frame: From the time of informed consent signed through 30 days after the last dose of AK117
Number of participants with a Dose Limiting Toxicity (DLT)
DLTs will be assessed during the first 21 days 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 .
Time frame: During the first 21 days
Objective response rate (ORR)
ORR defined as the proportion of subjects who achieves a best overall response of CR or PR, assessed by Investigator per RECIST Version 1.1 for solid tumor or the Lugano 2014 Classification for lymphoma
Time frame: Up to 2 years
Disease control rate (DCR)
The DCR is defined as the proportion of subjects with CR, PR, or SD .
Time frame: Up to 2 years
Maximum observed concentration (Cmax) of AK117
The endpoints for assessment of PK of AK104 include serum concentrations of AK117 at different timepoints after AK117 administration.
Time frame: From first dose of AK117 through to 30 days after last dose of AK117
Minimum observed concentration (Cmin) of AK117 at steady state
The endpoints for assessment of PK of AK104 include serum concentrations of AK117 at different timepoints after AK117 administration.
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Time frame: From first dose of AK117 through to 30 days after last dose of AK117
Number of subjects who develop detectable anti-drug antibodies (ADAs)
The immunogenicity of AK117 will be assessed by summarizing the number of subjects who develop detectable antidrug antibodies (ADAs).
Time frame: From first dose of AK117 through to 30 days after last dose of AK117