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

Launched by ADVENCHEN PHARMACEUTICALS, LLC. · May 2, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called AL8326 for patients with small cell lung cancer (SCLC) who have already received at least one prior treatment. AL8326 is a type of medication that targets specific receptors in cancer cells to help slow down or stop the growth of the cancer. The trial aims to find out how safe this medication is and how well it works in patients facing recurrent or advanced stages of SCLC.

To be eligible for this trial, participants should be at least 18 years old and have a confirmed diagnosis of SCLC. They should also be in relatively good health, as measured by a performance status scale, and have at least one measurable cancer lesion. However, certain health conditions may exclude candidates, such as serious bleeding disorders or significant heart problems. Participants in the trial will receive the oral medication AL8326 and will be monitored for any side effects and changes in their condition. This trial is currently recruiting, so interested patients or their families can reach out for more information.

Gender

ALL

Eligibility 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
• • 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