On October 14th, 2024, after three months of intense preparation including the formation of the clinical team, preparation of trial materials, and the selection of clinical service institutions, KeYe Biotech successfully launched Phase I clinical trial of its KY1 product at the Clinical Research Center of Shandong Cancer Hospital. KY1 (KY386 injection concentrate) is the world's first small-molecule targeted drug developed by KeYe Biotech that targets the RNA helicase DHX33 protein. This clinical trial marks the first human trial of a drug targeting the DHX33 protein, a milestone in cancer treatment.
The KY1 injection concentrate is designed for cancer patients who have failed standard treatments. This open-label, dose-escalation study aims to evaluate the safety, tolerability, and pharmacokinetics of KY1 in humans.
The principal investigators (PIs) for this clinical trial are Academician Jinming Yu and Director Yuping Sun from the Clinical Research Center of Shandong Cancer Hospital. Also in attendance at the kickoff meeting were medical experts, department heads from the Clinical Research Center, and management personnel from the clinical service institution. During the meeting, Director Sun and Dr. Yandong Zhang delivered welcome speeches from both the investigator's and sponsor’s perspectives, highlighting the significance and value of the study. Clinical experts then provided an in-depth analysis of the research background, the mechanism of KY1, the trial protocol, inclusion and exclusion criteria, standardized procedures for managing biological samples, and process management.
Following the meeting, operational handbook training for staff involved in the trial was conducted to ensure a smooth and swift transition to the first patient dosing phase.