Determine the Maximum Tolerated Dose (MTD) of FID-022 in patients with advanced solid tumors
Frequency and severity of abnormal clinical laboratory results, adverse events (AEs), severity of serious AEs (SAEs) and deaths graded according to the NCI-CTCAE version 5.0
DLTs graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5 .0. Maximum tolerated dose (MTD) will be determined based on DLT per protocol.
Identify the peak plasma concentration Cmax for 1). FID-022 as the original drug, 2). released two active components and 3). major known metabolites.
Determine time to the maximum observed plasma concentration (Tmax) for 1). FID-022 as the original drug, 2). released two active components and 3). major known metabolites.
Calculated area under the plasma concentration time curve (AUC0-t) of FID-022 with a focus on the key active component.
Calculated area under the plasma concentration time curve (AUC0-∞) of FID-022 with a focus on the key active component.
ORR defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
DCR defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) or a stable disease (SD) for at least 4 weeks or longer based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Duration of overall response is defined as the time from the date of first documented CR or PR, assessed by investigator and based on RECIST v. 1.1, to the documented date of progressive disease (PD) or death, whichever occurred first.
TTR is defined as the time from the initial dosing to the date of first documented response to the treatment, e.g. complete response or partial response, assessed by investigator and based on RECIST v. 1.1.
PFS defined as the time from the date the participant started study drug to the date the participant experiences an event of radiographic disease progression, clinical progression or death.
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