Phase 2 Study of APL-101 Oral Capsules for Treating Non-Small Cell Lung Cancer and Other Advanced Solid Tumors with MET Mutations or Dysregulation

What this Trial Is About

Researchers are evaluating the safety, effectiveness, and tolerability of APL-101 in treating various advanced solid tumors, especially non-small cell lung cancer NSCLC with MET Exon 14 skipping mutations, MET amplification, MET fusion, and tumors with overexpression of HGF and MET. This Phase 2 study follows a completed Phase 1 enrollment and focuses on patients with unresectable or metastatic cancers who have varying prior treatment histories and genetic tumor profiles. The study also examines APL-101 as an add-on therapy with EGFR inhibitors for NSCLC patients who developed resistance due to MET amplification. Participants receive APL-101 as oral capsules taken twice daily. The study includes multiple cohorts based on tumor type, prior treatment, and genetic characteristics, such as treatment-naive NSCLC patients with MET mutations, those previously treated with or without MET inhibitors, and patients with other solid tumors harboring specific MET alterations. One cohort also receives APL-101 combined with standard EGFR inhibitors. The treatment continues in cycles of 28 days, with ongoing assessment of response and safety. Throughout the study, participants undergo regular evaluations including imaging to identify measurable tumor lesions, laboratory tests, and functional assessments such as ECOG performance status or Karnofsky Performance Status for CNS tumors. Researchers measure outcomes like objective response rate, duration of response, time to progression, progression-free survival, and overall survival over periods extending up to three years. Safety monitoring includes organ function tests and tracking adverse effects. The total duration varies by participant based on treatment response and progression.

APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors