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Spots Global Cancer Trial Database for Phase 2 Safety and Efficacy Evaluation of AL8326 in ≥2nd Line SCLC

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Trial Identification

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

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

Study ID: NCT05363280

Study Description

Brief 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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Cleveland Clinic Florida, Weston, Florida, United States

Northwestern University, Evanston, Illinois, United States

Siteman Cancer Center, Washington University, Saint Louis, Missouri, United States

Cleveland Clinic, Cleveland, Ohio, United States

Contact Details

Name: Saiama Waqar, MD

Affiliation: Washington University School of Medicine

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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