Study on APL-101 for Treating Advanced Solid Tumors with Specific Genetic Changes

Program Overview

The purpose of this study is to evaluate how well APL-101 works as a treatment for advanced solid tumors, including non-small cell lung cancer (NSCLC), that have specific genetic changes in the MET gene. The study will also test APL-101 as an additional treatment for NSCLC that has developed resistance to standard therapies. Researchers aim to assess the effectiveness, safety, and tolerability of APL-101 in different groups of patients with these genetic changes.

Description

This study is divided into several groups based on the type of cancer and genetic changes present:

• Group A-1: Patients with NSCLC that has a specific MET gene mutation (Exon 14 skipping) and have not been treated with MET inhibitors before.
• Group A-2: Patients with NSCLC with the same MET mutation, who have been treated with up to three previous therapies but not with MET inhibitors.
• Group B: Enrollment completed.
• Group C: Patients with various solid tumors, excluding primary brain tumors, that have MET gene amplification, who have not been treated with MET inhibitors.
• Group C-1: Patients with NSCLC with MET amplification and normal EGFR gene, who have not been treated with MET inhibitors.
• Group C-2: Patients with NSCLC that have developed resistance to EGFR inhibitors due to MET amplification, who will receive APL-101 as an additional therapy.
• Group D: Patients with various solid tumors, excluding primary brain tumors, with MET gene fusions, who have not been treated with MET inhibitors.
• Group E: Patients with primary brain tumors with specific MET gene changes, who have not been treated with MET inhibitors.
• Group F: Patients with various solid tumors with overexpression of MET and HGF genes, who have not been treated with MET inhibitors.

The study will assess the effectiveness, safety, and tolerability of APL-101 in these groups.

Eligibility Criteria