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

Inclusion Criteria

• 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 Criteria

• 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