Study design
Cancer
CANCER
This was an open-label, multicenter, dose-finding, phase I study, with a standard 3 plus 3 dose-escalation design. Participating institutions include four university hospitals and Cancer centers in Japan. This study was conducted in accordance with the principles of the Declaration of Helsinki. All patients provided written informed consent before enrolment in the study. The study protocol was approved by the Certified Review Board of Wakayama Medical University. This study was registered on the clinical trials site of the Japan Registry of Clinical Trials (jRCTs051180008, registered date: 08/11/2018).