Evaluating AL8326 for advanced small cell lung cancer 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
This study is testing a new drug called AL8326 to see if it can help people with advanced small cell lung cancer who need a second treatment option.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Advenchen Laboratories, LLC Industry-sponsored |
| Locations | 7 sites (Birmingham, Alabama and 6 other locations) |
| Trial ID | NCT05363280 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with histologically confirmed SCLC who require second-line treatment and have a life expectancy of at least three months.
Not a fit: Patients with serious non-healing wounds, active bleeding disorders, or significant cardiovascular diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced small cell lung cancer who have limited treatment choices.
How similar studies have performed: Other studies have shown promise with similar multi-targeted therapies in treating small cell lung cancer, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Birmingham, Alabama and 6 other locations
- University of Alabama at Birmingham — Birmingham, Alabama, United States (Recruiting)
- Cleveland Clinic Florida — Weston, Florida, United States (Withdrawn)
- Northwestern University — Chicago, Illinois, United States (Completed)
- 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)
Study contacts
- Principal investigator: Saiama Waqar, MD — Washington University School of Medicine
- Study coordinator: Shiying Sprinzl
- Email: shiyings@advenchen.com
- Phone: 805-530-1550
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.