A Phase 2 Evaluation of the Safety and Efficacy of AL8326 in =2nd Line Small Cell Lung Cancer (SCLC) Treatment - AL8326-US-001

Advenchen Pharmaceuticals LLC0 sites130 target enrollmentFebruary 27, 2024

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Small Cell Lung Cancer (SCLC) patients who need =2nd line treatment without or with brain metastasis which is controlled with no active hemorrhage., Small Cell Lung Cancer (SCLC) patients who need =2nd line treatment without or with brain metastasis which is controlled with no active hemorrhage.
Sponsor: Advenchen Pharmaceuticals LLC
Enrollment: 130
Status: Active, not recruiting
Last Updated: last year

No summary available.

Registry

who.int

Start Date

February 27, 2024

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Advenchen Pharmaceuticals LLC

•1\. Male or female, 18 years of age or older. 2\. ECOG performance status of 0 or 1\. 3\. Histologically or cytologically confirmed SCLC. 4\. Have at least 1 lesion that meets the criteria for being measurable, as defined by RECIST 1\.1\. 5\. Have a life expectancy of at least 3 months.

•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.