Legutaxel

This study is an open, single-center, dose-escalation Phase I clinical trial to evaluate the safety, tolerability, and preliminary efficacy of injection of legutaxel in the treatment of patients with advanced malignant solid tumors. The research unit is Shanghai Oriental Hospital, and it is planned to screen 86 cases, with a maximum of 48 patients with advanced malignant solid tumors. The starting dose of injection of legutaxel is 40 mg/m2, the preset maximum dose is 720 mg/m2, and 8 dose groups are tentatively set. One subject was enrolled in the 40 mg/m2 dose group. If no grade 2 or higher toxicity related to the study drug occurs within 21 days of the DLT observation period, the dose will be escalated to the next group; if grade 2 or higher toxicity occurs during the accelerated titration stage (except for toxicity that the researcher determines is not a safety risk), the accelerated titration will be stopped and switched to a "3+3" escalation method. The 80 mg/m2 and above dose groups will adopt the 3+3 dose escalation method: each dose group will first enroll 3 subjects. If no DLT is observed during the DLT observation period, the dose will be escalated to the next dose group; if 2 DLTs occur, the dose escalation will be terminated; if 1 DLT occurs, 3 more subjects will be enrolled; if no DLT occurs in the newly enrolled 3 subjects, the dose will be escalated to the next dose group; if 1 DLT occurs in the newly enrolled 3 subjects, the dose escalation will be terminated. After obtaining certain safety results with single-drug dose escalation and preliminarily determining the RP2D and appropriate dosing regimen, the safety, tolerability and preliminary efficacy of the study drug will be further investigated; different dosing frequencies and patients with different tumor types may be explored.