NCT04890587

A Phase I Study of AL8326 in Advanced Solid Tumor

A Dose Escalation Tolerance and Pharmacokinetics Study of AL8326 in Advanced Solid Tumor

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Advenchen Laboratories Nanjing Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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;

Detailed 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.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	AL8326 tablets	Tablet:10mg/tablet; administered orally once daily in part 1 and part 2, administered orally twice daily for continuous 28-Day cycles in part 3.

Timeline

• Start date: 2017-08-17
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2021-05-18
• Last updated: 2021-05-18

Locations

2 sites across 1 country: China