J INTS BIO, WCLC 2023 - Presentation of Phase 1/2 study of 'JIN-A02', a Novel Oral 4th Generation EGFR TKI

This global phase 1/2 clinical study seeks to evaluate the safety, pharmacokinetics, and anti-tumor activity of "JIN-A02" in advanced NSCLC patients carrying EGFR mutations. This global phase 1/2 clinical study seeks to evaluate the safety, pharmacokinetics, and anti-tumor activity of "JIN-A02" in advanced NSCLC patients carrying EGFR mutations. This study is divided into three parts with dose escalation (Part A), dose exploration (Part B), and dose expansion (Part C). Part A explores...

This global phase 1/2 clinical study seeks to evaluate the safety, pharmacokinetics, and anti-tumor activity of "JIN-A02" in advanced NSCLC patients carrying EGFR mutations.

This study is divided into three parts with dose escalation (Part A), dose exploration (Part B), and dose expansion (Part C). Part A explores ascending doses of oral JIN-A02 monotherapy in 28-day cycles to evaluate the maximum tolerated dose in patients with advanced NSCLC harboring C797S or T790M mutation. Based on the results obtained in part A, a safety review committee will select 2 doses to be further evaluated in Part B by determining the safety, pharmacokinetics, and efficacy in the same way as Part A albeit in a larger cohort of patients. Once the recommended Phase 2 dose (RP2D) is determined, Part C, the dose expansion study, will begin with five cohorts of patients based on the EGFR mutations and brain metastasis status.

Dosing of the first patient with JIN-A02 was achieved in July 2023 and as of 11^th of September 2023, a total of three subjects have completed MTD evaluation period for Dose Level One of Part A. There was no DLT, no treatment related AE, and no clinical disease progression was noted.

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