Phase 12 Study of YH42946 for Safety and Effectiveness in Patients with Advanced or Metastatic Solid Tumors Showing HER2 or EGFR Exon 20 Alterations

What this Trial Is About

Researchers are evaluating YH42946, a new oral drug that targets HER2 and EGFR exon 20 insertions in patients with locally advanced or metastatic solid tumors. This Phase 12, open-label, multicenter study aims to assess the safety, tolerability, how the body processes the drug, and its anti-tumor activity. The study is sponsored by Yuhan Corporation and focuses on patients whose tumors have specific genetic changes involving HER2 and EGFR. The study has two parts. The first part involves gradually increasing doses of YH42946 to find the highest dose patients can tolerate safely. The second part expands the study to test selected doses in several patient groups to determine the recommended dose for future studies. Participants will receive YH42946 orally as the investigational treatment throughout these phases. Participants will undergo regular assessments including monitoring for side effects during the first 21 days, and evaluation of tumor response over about 12 months. Researchers will collect blood samples to study how the drug moves through and affects the body. Safety and treatment effects will be closely tracked to guide dosing decisions and understand the drugs impact. The total study duration varies depending on individual participation in dose escalation and expansion phases.

A Phase 1/2, Open-label, Multicenter, FIH Study to Evaluate Safety, Tolerability, PK and Anti-tumor Activity of YH42946