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Phase 2 Safety and Efficacy Evaluation of AL8326 in ≥2nd Line SCLC

Small Cell Lung Cancer Clinical Trial

Official title:
A Phase 2 Evaluation of the Safety and Efficacy of AL8326 in ≥2nd Line Small Cell Lung Cancer (SCLC) Treatment

Clinical Trial Summary

This trial is a Phase II trial designed to evaluate the safety and efficacy of using oral AL8326 , a multi-targeted receptor Tyrosine Kinase Inhibitor( TKI) , to recurrent, advanced, or metastatic small cell lung cancer (SCLC) patients who need ≥2nd line treatment .

Clinical Trial Description

This study is designed for two steps: Phase 2 Optimal Biological Dose (OBD) finding and Phase 2 expansion cohort study after OBD determination. The Phase 2 study aims to find optimal biological dose (OBD) initially. Patients will be randomized to 3 different dosing groups in OBD finding cohorts. Each cohort will enroll 6-12 SCLC patients who need ≥2nd line treatment without or with brain metastasis which is controlled with no active hemorrhage. This OBD finding cohort will also evaluate the pharmacokinetic profile of AL8326. A phase 2 expansion cohort will be continued if a positive clinical result would have been observed after OBD determination for 40-60 patients. Upon FDA's approval the Phase 2 expansion cohort clinical study will be further expanded to evaluate the safety and efficacy of AL8326 in patients individually with SCLC who need = or >2nd line treatment without or with brain metastasis which is controlled with no active hemorrhage. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05363280
Study type Interventional
Source Advenchen Laboratories, LLC
Contact Shiying Sprinzl
Phone 805-530-1550
Email shiyings@advenchen.com
Status Recruiting
Phase Phase 2
Start date November 1, 2022
Completion date December 2025
View Details
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