RecruitingPhase 2NCT05363280

Phase 2 Study for the Patient, Who Has Diagnosed With Small Cell Lung Cancer (SCLC) or Non Small Cell Lung Cancer (NSCLC) or Renal Cell Carcinoma (RCC) and Finished the First Line Stand Treatment , Need More Treatment

A Phase 2 Evaluation of the Safety and Efficacy of Veonetinib (AL8326) in ≥2nd Line Small Cell Lung Cancer (SCLC), Non Small Cell Lung Cancer (NSCLC) and Renal Cell Carcinoma (RCC) Treatment


Sponsor

Advenchen Pharmaceuticals, LLC.

Enrollment

80 participants

Start Date

Nov 1, 2022

Study Type

INTERVENTIONAL

Conditions

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 , Non-Small Cell Lung (NSCLC) and Renal Cell Carcinoma patients who need ≥2nd line treatment .


Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • Male or female, 18 years of age or older
  • ECOG performance status of 0 or 1
  • Histologically or cytologically confirmed SCLC /NSCLC/RCC
  • Have at least 1 lesion that meets the criteria for being measurable, as defined by RECIST 1.1
  • Have a life expectancy of at least 3 months

Exclusion Criteria7

  • 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.
  • More information available upon request

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Interventions

DRUGAL8326 40 mg

Taken AL3826 at 40mg QD orally

DRUGAL8326 60 mg

Taken AL3826 at 60mg QD orally

DRUGAL8326 80 mg--stopped

Taken AL3826 at 80 mg QD orally


Locations(7)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Cleveland Clinic Florida

Weston, Florida, 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

View Full Details on ClinicalTrials.gov

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NCT05363280


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