drugset / Trial / NCT04890587

A Phase I Study of AL8326 in Advanced Solid Tumor

NCT04890587

Phase 1 Unknown 40 enrolled Advenchen Laboratories, LLC
NaSingle-groupOpen-labelTreatment

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;

Timeline

Start
2017-08-17
Primary completion
2023-12
Completion
2023-12

Drugs

EvaluationDrugModalityDoseRoute
Subject AL8326 Unknown 10 mg Oral

Indications