Evaluating AL8326 for advanced small cell lung cancer treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase II trial aims to assess the safety and efficacy of AL8326, a multi-targeted receptor Tyrosine Kinase Inhibitor, in patients with recurrent, advanced, or metastatic small cell lung cancer (SCLC) requiring second-line treatment or beyond. The study consists of two phases: an Optimal Biological Dose (OBD) finding phase where patients are randomized into three dosing groups, and a subsequent expansion cohort phase if positive results are observed. The trial will also evaluate the pharmacokinetic profile of AL8326 in the initial phase.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Alabama at Birmingham
  Birmingham, Alabama, United States Recruiting
• Siteman Cancer Center, Washington University
  St Louis, Missouri, United States Recruiting
• Cleveland Clinic
  Cleveland, Ohio, United States Recruiting
• Hospital Universitari Vall d'Hebron
  Barcelona, Spain Recruiting
• Hospital Universitario Ramón Y Cajal
  Madrid, Spain Recruiting
• Cleveland Clinic Florida
  Weston, Florida, United States Withdrawn

Study contacts

• Principal investigator: Saiama Waqar, MD — Washington University School of Medicine
• Study coordinator: Shiying Sprinzl
• Email: shiyings@advenchen.com
• Phone: 805-530-1550

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.