Study design
PK/PD
MAY, SOLID TUMORS
This study was an open-label, phase I study (Clinicaltrials.gov identifier: NCT05649761) designed to evaluate the safety, tolerability, PK/PD, and antitumor activity of QL1604 in patients with advanced or metastatic solid tumors. The study conducted at the two centers in China was initiated on 29 May 2019. This study included dose-escalation and dose-expansion phases. For dose escalation, an accelerated titration combined with a 3 + 3 dose-escalation design was used. The planned doses were 0.3 mg/kg, 1 mg/kg, 3 mg/kg, and 10 mg/kg once every 2 weeks (Q2W). The 0.3 mg/kg cohort planned to enroll one patient, and 3 + 3 dose-escalation method was used for other cohorts. For expansion phase, 3 mg/kg Q2W, 3 mg/kg once every 3 weeks (Q3W), 10 mg/kg Q2W and 200 mg of fixed dose Q3W were planned doses.The study protocol and all amendments were approved by the Ethics Committee of each center and conducted in compliance with the Declaration of Helsinki and the international standards of Good Clinical Practice. Written informed consent was obtained from all patients before start of any study procedure.