A Phase I Study of AL8326 in Advanced Solid Tumor

Status Recruiting

Clinical Trial Summary

1. 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). 2. 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;

Clinical Trial Description

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. 1. 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. 2. Part II Subject will receive a dose from Part 1 of this study for continuous 28-Day cycles of therapy. 3. Part III This design adopts 3 + 3 dose de-escalation method for exploration. At the same time, the safety, tolerance and pharmacokinetics were observed. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04890587
Study type	Interventional
Source	Advenchen Laboratories, LLC
Contact	Yingyin Li
Phone	+8657188683590
Email	annel@advenchen.com
Status	Recruiting
Phase	Phase 1
Start date	August 17, 2017
Completion date	December 2023

View Details

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