NCT05363280

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

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Advenchen Pharmaceuticals, LLC. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 .

Detailed 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.

Conditions

• Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	AL8326 low dose group	Taken AL3826 at low dose orally
DRUG	AL8326 middle dose group	Taken AL3826 at middle dose orally
DRUG	AL8326 high dose group	Taken AL3826 at high dose orally

Timeline

• Start date: 2022-11-01
• Primary completion: 2025-12-01
• Completion: 2026-12-01
• First posted: 2022-05-05
• Last updated: 2025-09-23

Locations

6 sites across 2 countries: United States, Spain

Regulatory

• FDA-regulated drug study