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

Description

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 .

Conditions

Small Cell Lung Cancer

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Study Overview

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Study Details

Study overview

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 .

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

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

Condition
Small Cell Lung Cancer
Intervention / Treatment

-

Contacts and Locations

Birmingham

University of Alabama at Birmingham, Birmingham, Alabama, United States, 35294

Weston

Cleveland Clinic Florida, Weston, Florida, United States, 33331

Evanston

Northwestern University, Evanston, Illinois, United States, 60208

Saint Louis

Siteman Cancer Center, Washington University, Saint Louis, Missouri, United States, 63130

Cleveland

Cleveland Clinic, Cleveland, Ohio, United States, 44195

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Advenchen Pharmaceuticals, LLC.,

Saiama Waqar, MD, PRINCIPAL_INVESTIGATOR, Washington University School of Medicine

Study Record Dates

2025-12