2024 World Conference on Lung Cancer (WCLC) - Posters-P3.12D.02 Phase 1/2 Clinical Trial of JIN-A02, a 4th Generation EGFR-TKI in EGFR Mutated Advanced/metastatic Non-Small Cell Lung Cancer (NSCLC)

P3.12D.02 Phase 1/2 Clinical Trial of JIN-A02, a 4th Generation EGFR-TKI in EGFR Mutated Advanced/metastatic Non-Small Cell Lung Cancer (NSCLC)

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The document presents a study on JIN-A02, a fourth-generation EGFR-TKI, targeting patients with resistance to previous EGFR-TKI therapies, specifically those with advanced or metastatic NSCLC (non-small cell lung cancer) exhibiting EGFR mutations. EGFR mutations are a primary cause of resistance in non-squamous NSCLC, and while EGFR-TKIs are effective initially, resistance inevitably develops. JIN-A02 aims to treat these resistant cases, including those with the C797S mutation, found in patients who have become resistant to third-generation EGFR-TKI therapies.<br /><br />The study operates under a Phase 1/2 trial, with an open-label, multicenter design, assessing the safety and anti-tumor efficacy of JIN-A02. Part A of the study involves a dose escalation phase to determine the maximum tolerated dose (MTD) over five cohorts, ranging from 12.5 mg to 150 mg dosages. As of the data cut-off on August 15, 2024, 15 subjects participated, and JIN-A02 showed promise with observed partial responses and stable disease states, particularly at 50 mg and 100 mg dosages. Notably, these doses resulted in tumor size reductions of 77.3% and 35.3%, respectively. Additionally, JIN-A02 showed promising activity against brain metastases, with one cohort achieving stable disease.<br /><br />Safety evaluations indicate that JIN-A02 is well-tolerated, with no dose-limiting toxicities (DLTs) reported up to 150 mg. Common treatment-emergent adverse events (TEAEs) were recorded in 93.3% of the subjects, but no grade 3 or more treatment-related adverse events (TRAEs) were observed. The study continues to recruit participants, reflecting JIN-A02's potential as a viable treatment option for patients with NSCLC resistant to earlier EGFR-TKI therapies.

Asset Subtitle

Sun Min Lim

Meta Tag

Speaker Sun Min Lim

Topic Metastatic NSCLC – Targeted Therapy

Keywords

JIN-A02

EGFR-TKI

NSCLC

EGFR mutations

C797S mutation

Phase 1/2 trial

dose escalation

tumor size reduction

brain metastases

treatment-emergent adverse events