2023 World Conference on Lung Cancer (Posters)-P2.09. A Phase 1, 2 Study to Evaluate the Safety and Anti-tumor Activity of JIN-A02 in Patients with EGFR Mutant Advanced NSCLC

P2.09. A Phase 1, 2 Study to Evaluate the Safety and Anti-tumor Activity of JIN-A02 in Patients with EGFR Mutant Advanced NSCLC - PDF(Abstract)

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A phase 1/2 study is being conducted to evaluate the safety and anti-tumor activity of JIN-A02 in patients with EGFR mutant advanced non-small cell lung cancer (NSCLC). EGFR mutations are the most common driver mutations in NSCLC, and while EGFR tyrosine kinase inhibitors (TKIs) are the recommended treatment, patients eventually develop acquired resistance. JIN-A02 is a 4th generation EGFR TKI that selectively binds to EGFR mutations, including the C797S mutation that causes resistance to Osimertinib. In preclinical studies, JIN-A02 has shown activity as a monotherapy in models with EGFR mutations resistant to Osimertinib.<br /><br />The study is an international, open-label, phase 1/2 trial divided into three parts. Part A explores ascending daily doses of oral JIN-A02 monotherapy to determine the maximum tolerated dose in patients with advanced NSCLC harboring the C797S or T790M mutation. Part B will evaluate the safety, pharmacokinetics, and efficacy of two selected doses in a larger cohort of patients. Once the recommended phase 2 dose is determined, Part C, the dose expansion study, will be conducted in five cohorts based on EGFR mutation and brain metastasis status.<br /><br />Cohort 1 and 2 of Part C will evaluate the clinical activity of JIN-A02 in patients with EGFR C797S and T790M mutations. Cohort 3, 4, and 5 are exploratory and aim to assess the efficacy and safety of JIN-A02 in specific patient populations. The primary endpoints of the study include dose limiting toxicity and adverse events, recommended phase 2 dose, and objective response rate.<br /><br />The study is ongoing, with Part A already underway in the US, approved in Korea, and awaiting regulatory approval in Thailand. The trial aims to provide valuable insights into the safety and anti-tumor activity of JIN-A02 in EGFR mutant NSCLC patients, particularly those with acquired resistance to current EGFR TKIs.

Asset Subtitle

Sun Min Lim

Meta Tag

Speaker Sun Min Lim

Topic Metastatic NSCLC: Targeted Therapy - EGFR/HER2

Keywords

JIN-A02

EGFR mutant

NSCLC

acquired resistance

4th generation EGFR TKI

C797S mutation

Osimertinib

monotherapy

dose expansion study

objective response rate