Study oversight
SOLID TUMORS
We enrolled patients with advanced solid tumors in a first-in-human, phase I, open-label, dose-escalation study. Patients were recruited at one site, the Magna Graecia University/AOU Mater Domini Hospital (now AOU Renato Dulbecco), Catanzaro, Italy. The study was approved by the Regulatory Authorities AIFA/ISS (Italy) in March 2018 and the local Ethics Committee in July 2018. The first patient was enrolled on February 2019, and the study was closed on December 2021. The study was registered during the trial conduction, after accrual of 10 patients (ClinTrials.Gov NCT04811898). The design of the trial is shown in the Additional file 