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Clinical Trials in the USA / NCT05363280
Recruiting Phase 2

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

NCT05363280 · tracked via the Priya Life Science USA tracker
Sponsor
Advenchen Pharmaceuticals, LLC.
Phase
Phase 2
Started
2022-11-01
Last updated
2026-05-08

Condition(s) studied

Small Cell Lung CancerRenal Cell Carcinoma (RCC)Non-Small Cell Lung

Investigational drug(s) / intervention(s)

AL8326 40 mgAL8326 60 mgAL8326 80 mg--stopped

AL8326 40 mg: Taken AL3826 at 40mg QD orally

AL8326 60 mg: Taken AL3826 at 60mg QD orally

AL8326 80 mg--stopped: Taken AL3826 at 80 mg QD orally

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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 /NSCLC/RCC 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

Primary outcome measure(s)

Trial sites (7)

FacilityCityRegionStatus
University of Alabama at Birmingham Birmingham Alabama Recruiting
Cleveland Clinic Florida Weston Florida Withdrawn
Northwestern University Chicago Illinois Completed
Siteman Cancer Center, Washington University St Louis Missouri Recruiting
Cleveland Clinic Cleveland Ohio Recruiting
Hospital Universitari Vall d'Hebron Barcelona Spain Recruiting
Hospital Universitario Ramón Y Cajal Madrid Spain Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05363280 on ClinicalTrials.gov ↗ ← All trials in the USA