Phase 12 Study of BH-30643 for Adults with Advanced or Metastatic Non-Small Cell Lung Cancer Having EGFR or HER2 Mutations

What this Trial Is About

Researchers are evaluating BH-30643, a new oral drug designed to treat patients with locally advanced or metastatic non-small cell lung cancer NSCLC who have specific mutations in the EGFR andor HER2 genes. This Phase 12 open-label study aims to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and early anti-tumor effects of BH-30643. The study will focus on patients with a variety of EGFR mutations, including common and atypical ones, and those resistant to previous treatments. In Phase 1, participants receive BH-30643 either alone or combined with chemotherapy drugs Carboplatin and Pemetrexed, with doses gradually increased to find the best dose for further study. Phase 2 will further explore the drugs effectiveness and safety at the recommended dose in groups defined by their mutation type or treatment history. BH-30643 is taken orally as capsules or tablets, and chemotherapy is given following standard care when combined. Participants will undergo regular assessments including scans to measure tumor size, blood tests to monitor drug levels and safety, and questionnaires about symptoms and quality of life. The study monitors side effects from the start through completion, which may last up to about four years. Researchers will measure outcomes like dose-limiting toxicities, tumor response rates, progression-free survival, and overall survival to understand how the treatment works over time.

A Study of BH-30643 in Subjects With Locally Advanced or Metastatic NSCLC Harboring EGFR and/or HER2 Mutations