Statistical analysis
SD
DISEASE, DISEASE
No statistical hypothesis was specified for this study. For the dose-escalation phase, an accelerated titration combined with a 3 + 3 dose-escalation design was used. The 0.3 mg/kg cohort planned to enroll one patient (accelerated titration). On the basis of the 3 + 3 design, three to six patients were planned to be enrolled to other dose cohorts. For the expansion phase, additional patients were enrolled to selected dose cohorts to ensure at least eight patients PK evaluable patients in each dose cohort. A total of 21 to 42 patients were to be enrolled in the expansion phase.The efficacy analysis based on the full analysis set included all patients who received at least one dose of QL1604. Objective response rate (ORR) was defined as the proportion of patients with CR or partial response (PR), assessed by the investigator per RECIST v1.1. Disease control rate (DCR) was defined as the proportion of patients with CR, PR, or stable disease (SD), assessed by the investigator per RECIST v1.1. The safety analysis population included all patients who received at least one dose of QL1604 and had a safety record after treatment.ORR and DCR point estimates were accompanied by 95% CIs using the Clopper–Pearson exact method. Summary statistics were provided for AEs. PK parameters for QL1604 were calculated using non-compartmental model by WinNonlin 6.4 (Certara, Inc.). All statistical analyses were performed using SAS (version 9.4) (SAS Institute Inc., Cary, NC).