Status:
ACTIVE_NOT_RECRUITING
Phase 2 Safety and Efficacy Evaluation of AL8326 in ≥2nd Line SCLC
Lead Sponsor:
Advenchen Pharmaceuticals, LLC.
Conditions:
Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 sma...
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 ...
Eligibility Criteria
Inclusion
- Major
- Male or female, 18 years of age or older
- ECOG performance status of 0 or 1
- Histologically or cytologically confirmed SCLC
- 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
- Major
Exclusion
- Serious, non-healing wound, ulcer or bone fracture
- Major surgical procedure within 28 days or minor surgical procedure performed within 7 days prior to treatment
- Active bleeding or pathologic conditions that carry high risk of bleeding, such as known bleeding disorder, coagulopathy, or tumor involving major vessels
- Clinically significant cardiovascular disease including uncontrolled hypertension; myocardial infarction or unstable angina within 6 months prior to enrollment; New York Heart Association (NYHA) Grade II or greater congestive heart failure serious cardiac arrhythmia requiring medication; and Grade II or greater peripheral vascular disease
- Hemoptysis within 3 months prior to enrollment
- Concomitant treatment with strong inhibitors or inducers of CYP3A4, CYP2C9 and CYP2C19 within 14 days prior to enrollment and during the study unless there is an emergent or life-threatening medical condition that required it.
- More information available upon request
Key Trial Info
Start Date :
November 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT05363280
Start Date
November 1 2022
End Date
December 1 2026
Last Update
September 23 2025
Active Locations (6)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
Northwestern University
Chicago, Illinois, United States, 60611
3
Siteman Cancer Center, Washington University
St Louis, Missouri, United States, 63130
4
Cleveland Clinic
Cleveland, Ohio, United States, 44195