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NCT05363280 | RECRUITING | Small Cell Lung Cancer

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

Advenchen Pharmaceuticals, LLC.

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 small cell lung cancer (SCLC) patients who need ≥2nd line treatment .

Condition or disease

Small Cell Lung Cancer

Intervention/treatment

AL8326 low dose group

AL8326 middle dose group

AL8326 high dose group

Phase

PHASE2

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 (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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 36 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Phase 2 Evaluation of the Safety and Efficacy of AL8326 in ≥2nd Line Small Cell Lung Cancer (SCLC) Treatment
Actual Study Start Date : 2022-11-01
Estimated Primary Completion Date : 2024-12
Estimated Study Completion Date : 2025-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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 by RECIST 1.1
  • 5. Have a life expectancy of at least 3 months
  • 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 as known 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; 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
    • 5. Hemoptysis within 3 months prior to enrollment
    • 6. 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
Phase 2 Safety and Efficacy Evaluation of AL8326 in ≥2nd Line SCLC

Location Details

NCT05363280

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Albama

University of Alabama at Birmingham

Birmingham, Albama, United States, 35294

RECRUITING

United States, Florida

Cleveland Clinic Florida

Weston, Florida, United States, 33331

RECRUITING

United States, Illinois

Northwestern University

Evanston, Illinois, United States, 60208

RECRUITING

United States, Missouri

Siteman Cancer Center, Washington University

Saint Louis, Missouri, United States, 63130

RECRUITING

United States, Ohio

Cleveland Clinic

Cleveland, Ohio, United States, 44195