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(Slides)

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Researchers conducted a phase 1/2 study to evaluate the safety and effectiveness of JIN-A02, a fourth-generation EGFR tyrosine kinase inhibitor (TKI), in patients with EGFR mutant advanced NSCLC. The study aimed to address the issue of acquired resistance and disease progression that patients with EGFR-mutant NSCLC often face with current treatments.<br /><br />The study was divided into three parts: dose escalation, dose exploration, and dose expansion. In the dose escalation phase, different doses of JIN-A02 were administered to evaluate the maximum tolerated dose in patients with specific EGFR mutations. The dose exploration phase expanded on the results obtained from the previous phase by evaluating the safety, pharmacokinetics, and efficacy of two selected doses in a larger cohort of patients. Once the recommended phase 2 dose (RP2D) was determined, the dose expansion study was planned to further evaluate the antitumor activity of JIN-A02 in five cohorts based on EGFR mutation and brain metastasis status.<br /><br />As of August 2023, three patients were enrolled in the study, and no clinical disease progression or adverse events related to JIN-A02 were reported. The study is ongoing, and the researchers have not observed any treatment-related adverse events or disease progression.<br /><br />Overall, this study aims to provide valuable insights into the safety and anti-tumor activity of JIN-A02 in patients with EGFR mutant advanced NSCLC, particularly in those with acquired resistance to current EGFR TKIs. The results obtained from this study may contribute to the development of improved treatment options for this patient population.

Asset Subtitle

Sun Min Lim

Meta Tag

Speaker Sun Min Lim

Topic Metastatic NSCLC: Targeted Therapy - EGFR/HER2

Keywords

JIN-A02

EGFR tyrosine kinase inhibitor

NSCLC

acquired resistance

dose escalation

dose exploration

recommended phase 2 dose

antitumor activity

clinical disease progression

improved treatment options