South Korea-based J INTS BIO has dosed the first patient in a global multi-centre Phase I/II clinical study of JIN-A02 for non-small cell lung cancer (NSCLC) patients.

The global Phase I/II clinical trial (NCT05394831) seeks to evaluate the safety, pharmacokinetics, and anti-tumour activity of JIN-A02 in EGFR mutant-positive, advanced NSCLC subjects with disease progression post-standard anticancer therapy, including approved EGFR-TKI therapy and/or no more than a single platinum-based anticancer chemotherapy.

JIN-A02 is an orally administered epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI). The binding of EGF induces a conformational change that facilitates receptor homodimer or heterodimer formation, resulting in the activation of EGFR tyrosine kinase activity. By inhibiting the EGF binding, the drug candidate inhibits cell growth, induces apoptosis and helps in therapeutic intervention of the disease.

First dosing

The first patient was dosed on 31 July 2023 at Severance Hospital, Seoul, Korea. More clinical sites will follow suit, including seven more hospitals in Korea (Asan Medical Center, Chungbuk National University Hospital, National Cancer Center, Samsung Seoul Hospital, Seoul National University Hospital, Seoul St Mary's Hospital, St Vincent Hospital), two in the United States, and one in Thailand. The researchers are hoping to enrol 150 participants globally.

J INTS BIO CEO Anna Jo said: "We expect the positive results of JIN-A02 in the pre-clinical studies to translate to positive outcomes for patients in the clinical trial. We hope also to proceed with the application for designation of an orphan drug, and thereby quickly occupy the global NSCLC therapy market through conditional use."

Different parts

The study will be conducted in three parts. In Part A of the study, dose escalation will be carried out to determine the maximum tolerable dose (MTD) using Bayesian Optimal Interval (BOIN) design.

In Part B, further dose exploration will be examined to evaluate the safety of JIN-A02 and to determine the recommended Phase II dose (RP2D). Part C, a dose expansion study, will see patients with EGFR mutation who show disease progression after receiving standard anticancer therapy divided into five different cohorts based on the EGFR mutation for the activity of JIN-A02 to be evaluated.