Definitions and statistical analysis
DLTs, overdose
REGRESSION
All patients who received at least one milademetan dose were included in the safety analysis set. The MTD analysis set included patients who received at least one milademetan dose, had no missing data for examination or observation during the DLT evaluation period, and had a completed DLT evaluation. Without DLTs, the included patients received ≥ 75% milademetan of the specified days in cycle 1. Patients who experienced DLT during the DLT evaluation period and resumed the study treatment at a lower dose were included in the initial dose cohort. The efficacy analysis set included all patients who received at least one milademetan dose and underwent efficacy evaluation at least once after treatment initiation. The PK analysis set comprised patients who received at least one milademetan dose, for whom a PK sample was collected at least once after initiating treatment, and who had available PK measurement data. The biomarker analysis set included all patients who received at least one milademetan dose, whose specimens were collected for biomarker studies, and who had available measurement data. Following the first cycle, doses for subsequent cohorts were guided by an mCRM based on a Bayesian logistic regression model incorporating the escalation with the overdose control principle, clinical evaluation of the toxicological profile, and pharmacokinetics and pharmacodynamics information. Continuous variables were summarized with mean, standard deviation, and minimum, median, and maximum values, while categorical variables were summarized with a frequency table.In addition to descriptive statistics, the geometric mean and geometric coefficient of variation were used to describe the PK parameters. All analyses were conducted using SAS