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

Last updated: September 18, 2025
Sponsor: Advenchen Pharmaceuticals, LLC.
Overall Status: Active - Not Recruiting

Phase

2

Condition

Small Cell Lung Cancer

Treatment

AL8326 middle dose group

AL8326 low dose group

AL8326 high dose group

Clinical Study ID

NCT05363280
AL8326-US-001
  • Ages > 18
  • All Genders

Study 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 .

Eligibility Criteria

Inclusion

Major Inclusion Criteria:

  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 byRECIST 1.1

  5. Have a life expectancy of at least 3 months

Exclusion

Major Exclusion Criteria:

  1. Serious, non-healing wound, ulcer or bone fracture

  2. Major surgical procedure within 28 days or minor surgical procedure performed within 7 days prior to treatment

  3. Active bleeding or pathologic conditions that carry high risk of bleeding, such asknown bleeding disorder, coagulopathy, or tumor involving major vessels

  4. Clinically significant cardiovascular disease including uncontrolled hypertension;myocardial infarction or unstable angina within 6 months prior to enrollment; NewYork Heart Association (NYHA) Grade II or greater congestive heart failure seriouscardiac arrhythmia requiring medication; and Grade II or greater peripheral vasculardisease

  5. Hemoptysis within 3 months prior to enrollment

  6. Concomitant treatment with strong inhibitors or inducers of CYP3A4, CYP2C9 andCYP2C19 within 14 days prior to enrollment and during the study unless there is anemergent or life-threatening medical condition that required it.

More information available upon request

Study Design

Total Participants: 36
Treatment Group(s): 3
Primary Treatment: AL8326 middle dose group
Phase: 2
Study Start date:
November 01, 2022
Estimated Completion Date:
December 31, 2026

Study 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.

Connect with a study center

  • Hospital Universitari Vall d'Hebron

    Barcelona 3128760,
    Spain

    Site Not Available

  • Hospital Universitario Ramón Y Cajal

    Madrid 3117735,
    Spain

    Site Not Available

  • University of Alabama at Birmingham

    Birmingham, Alabama 35294
    United States

    Site Not Available

  • University of Alabama at Birmingham

    Birmingham 4049979, Alabama 4829764 35294
    United States

    Site Not Available

  • Cleveland Clinic Florida

    Weston, Florida 33331
    United States

    Site Not Available

  • Northwestern University

    Evanston, Illinois 60208
    United States

    Site Not Available

  • Northwestern University

    Chicago 4887398, Illinois 4896861 60611
    United States

    Site Not Available

  • Siteman cancer center, Washington University

    Saint Louis, Missouri 63130
    United States

    Site Not Available

  • Siteman Cancer Center, Washington University

    St Louis 4407066, Missouri 4398678 63130
    United States

    Site Not Available

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Cleveland Clinic

    Cleveland 5150529, Ohio 5165418 44195
    United States

    Site Not Available

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