A Phase 2 Evaluation of the Safety and Efficacy of Veonetinib (AL8326) in ≥2nd Line Small Cell Lung Cancer (SCLC), Non Small Cell Lung Cancer (NSCLC) and Renal Cell Carcinoma (RCC) Treatment
Status: Recruiting
Location: See all (7) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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 , Non-Small Cell Lung (NSCLC) and Renal Cell Carcinoma patients who need ≥2nd line treatment .
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Male or female, 18 years of age or older
• ECOG performance status of 0 or 1
• Histologically or cytologically confirmed SCLC /NSCLC/RCC
• Have at least 1 lesion that meets the criteria for being measurable, as defined by RECIST 1.1
• Have a life expectancy of at least 3 months
Locations
United States
Alabama
University of Alabama at Birmingham
RECRUITING
Birmingham
Florida
Cleveland Clinic Florida
WITHDRAWN
Weston
Illinois
Northwestern University
COMPLETED
Chicago
Missouri
Siteman Cancer Center, Washington University
RECRUITING
St Louis
Ohio
Cleveland Clinic
RECRUITING
Cleveland
Other Locations
Spain
Hospital Universitari Vall d'Hebron
RECRUITING
Barcelona
Hospital Universitario Ramón Y Cajal
RECRUITING
Madrid
Contact Information
Primary
Shiying Sprinzl
shiyings@advenchen.com
805-530-1550
Backup
Judy Chen
Judyc@advenchen.com
805-530-1550
Time Frame
Start Date: 2022-11-01
Estimated Completion Date: 2028-12
Participants
Target number of participants: 80
Treatments
Experimental: OBD finding cohort at low dose--completed
Subject in low dose group will receive AL8326 orally in each cycle until intolerable toxicity or disease progression or withdrawal . 6-12 subjects are in this group. Efficacy, safety and PK will be evaluated and compared within 3 different dosing group to define the final OBD.
Experimental: OBD finding cohort at middle dose--completed
Subject in middle dose group will receive AL8326 orally in each cycle until intolerable toxicity or disease progression or withdrawal . 6-12 subjects are in this group. Efficacy, safety and PK will be evaluated and compared within 3 different dosing group to define the final OBD.
Experimental: OBD finding cohort at high dose--completed
Subject in high dose group will receive AL8326 orally in each cycle until intolerable toxicity or disease progression or withdrawal . 6-12 subjects are in this group. Efficacy, safety and PK will be evaluated and compared within 3 different dosing group to define the final OBD.
Experimental: Non-Small Cell Lung(NSCLC)
≥2nd line NSCLC patient in 40 mg dose
Experimental: Renal Cell Carcinoma( RCC )
≥2nd line RCC patient in 60 mg dose
Authors
Related Therapeutic Areas
Sponsors
Leads: Advenchen Pharmaceuticals, LLC.