This phase 1/2 trial will investigate the safety and effectiveness of APL-101 in advanced non-small cell lung cancer (NSCLC).
The main outcomes will be to determine the recommended phase 2 dose (RP2D) and the response rate (RR) in phase 2. This trial is recruiting at multiple locations across the US.
The details
Treatment options are limited for patients with advanced cancers. Lung cancer (LC) is commonly diagnosed at an advanced stage. Chemotherapy and radiation therapy can slow the disease. New drugs are in development for advanced LC. APL-101 is an experimental drug. It targets mutations in the c-MET gene. Some advanced tumors have dysregulated c-MET function. This allows them to grow rapidly. APL-101 is also known as a tyrosine kinase inhibitor (TKI).
This trial will investigate the safety of APL-101 in advanced NSCLC. The main outcome will be to determine the RP2D and the RR in phase 2.
Who are they looking for?
This study will recruit 110 patients with advanced NSCLC. Patients can take part in the study if they do not have major surgery planned in the next 4 weeks. To enter phase 2 patients must have c-Met dysregulation.
Patients cannot take part in the trial if they have an allergy to APL-101. Patients with tumor mutations in EGFR, ALK or ROS1 genes are excluded from the trial. Participants cannot have had prior treatment with a TKI. Other exclusion criteria are a history of heart or gastrointestinal disease, uncontrolled epilepsy or brain tumors. Breastfeeding women are also excluded from the trial.
How will it work
All patients will receive ALP-101. In phase 1, patients will be randomly assigned to a dose of APL-101. The doses range from 10-500 mg taken twice daily. Treatment will last 28 days. The maximum tolerated dose (MTD) will be determined from phase 1. This will be the RP2D. In phase 2, patients will take doses up to the MTD for up to 1 year.
The main outcomes are to determine the RP2D and the RR in phase 2. Patients will be followed up for 2 years.
