This is Phase 1, Multicenter, Open-Label, Dose-Escalation and Dose-Exploration Study to Evaluate the Safety, Pharmacokinetics, and Anti-tumor Activity of AK119 (Anti-CD73) in Subjects with Advanced or Metastatic Solid Tumors.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Subjects will receive AK119 intravenously.
Fudan University Zhongshan Hospital
Shanghai, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, 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 90 days after the last dose of study drug
Number of participants with a Dose Limiting Toxicity (DLT)
DLTs will be assessed during the first 4 weeks of treatment for dose-escalation phase and first 3 weeks for dose-exploration phase. 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 in dose-escalation phase, during the first 3 weeks in dose-exploration phase
Serum PK concentration of AK119
Serum PK concentration of AK119 in individual subjects at different time points after AK119 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 AK119 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 90 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.
Time frame: Up to 2 years
Disease control rate (DCR)
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DCR is defined as the proportion of subjects with CR, PR, or SD.
Time frame: Up to 2 years
Progression-free survival (PFS)
PFS is defined as the time from the start of treatment with AK119 until the first documentation of disease progression or death due to any cause, whichever occurs first.
Time frame: Up to 2 years