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Phase 2 Safety and Efficacy Evaluation of AL8326 in ≥2nd Line SCLC | Clinical Trials | Clareo Health

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

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

NCT05363280•Advenchen Pharmaceuticals, LLC.

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 .

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

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

Locations (6)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Northwestern University

Chicago, Illinois, United States

Siteman Cancer Center, Washington University

St Louis, Missouri, United States

Cleveland Clinic

Cleveland, Ohio, United States

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Hospital Universitario Ramón Y Cajal

Madrid, Spain

Key Dates

Start Date

November 1, 2022

Primary Completion Date

December 1, 2025

Completion Date

December 1, 2026

Last Updated

September 23, 2025

Enrollment

ESTIMATED participants

Conditions

Small Cell Lung Cancer

Interventions

AL8326 low dose group

DRUG

AL8326 middle dose group

DRUG

AL8326 high dose group

DRUG

A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)

NCT07190248

Non-small Cell Lung Cancer

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Reducing the Incidence of Symptomatic Brain Metastases With MRI Surveillance

NCT05692635

Brain MetastasesNonsmall Cell Lung Cancer Stage III

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 23, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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