Main purpose Objective to study the tolerance and safety of single and multiple
administration of repeated 28-day cycles of AL8326 in patients with advanced solid
tumor, observe the dose limiting toxicity (DLT) and maximum tolerated dose (MTD).
Secondary purpose 1) Preliminary analysis of the pharmacokinetic characteristics and
efficacy of repeated 28-day cycles of AL8326 tablets in patients with advanced solid
tumors; 2) According to the results of phase I tolerance test and pharmacokinetics,
appropriate dosage and regimen were recommended for phase II clinical trial;
This is a Phase 1 study to evaluate the safetyand efficacy of 28-day cycles of AL8326
therapy. The study is divided into three parts.
Part I To evaluate the dose limiting toxicity (DLT) and general safety during the first
28-day cycle of Al8326 therapy and to evaluate the MTD. It will include a evaluation of
3 subjects per cohort in a 3+3 design in.
Part II Subject will receive a dose from Part 1 of this study for continuous 28-Day
cycles of therapy.
Part III This design adopts 3 + 3 dose de-escalation method for exploration. At the same
time, the safety, tolerance and pharmacokinetics were observed.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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