A Phase 1 study to evaluate the safety, tolerability, PK, immunogenicity, pharmacodynamics, and preliminary antitumor activity of AK114.
This is a first-in-human (FIH), Phase 1a, multicenter, open-label, single-arm dose-escalation study of AK114 to evaluate the safety, tolerability, PK, pharmacodynamics, antitumor activity and immunogenicity in adult subjects with advanced or metastatic solid tumors. The study is comprised of dose escalation phase. Approximately 30 subjects will be treated in this study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
AK114 administered by subcutaneous injection
Ashford Cancer Centre
Kurralta Park, South Australia, Australia
Incidence of 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 drug, whether or not considered related to the study drug.
Time frame: From the time of informed consent signed through to 90 days after last dose of study drug
Number of participants with a Dose Limiting Toxicity (DLTs)
DLTs will be assessed as having a suspected relationship to study drug according to pre-specific criteria in the protocol.
Time frame: Within the first 28 days after receiving the first dose of study drug
Serum pharmacokinetics (PK)
Serum concentrations of study drug in individual subjects at different time points after study drug administration
Time frame: From first dose of treatment through to 90 days after end of treatment
Number of subjects who develop detectable anti-drug antibodies (ADAs)
The immunogenicity of study drug will be assessed by summarizing the number of subjects who develop detectable ADAs.
Time frame: From first dose of study drgu through to 90 days after end of treatment
Objective response rate (ORR)
The ORR is defined as the proportion of subjects with confirmed complete response (CR) or confirmed partial response (PR), based on RECIST Version 1.1.
Time frame: Up to 2 years
Disease control rate (DCR)
DCR is defined as the number (%) of subjects with best of response of confirmed CR or PR, or stable disease (SD) according to RECIST v1.1.
Time frame: Up to 2 years
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