A Phase 1/2 Study to Evaluate the Safety, Tolerability and PK of JIN-A02 in Patients With EGFR Mutant Advanced NSCLC

• Status: Not yet recruiting
• Trial end date: 2024-12-31

Summary

This study is a phase 1/2, open-labeled, multicenter clinical trial to evaluate the safety, tolerability, PKs, and preliminary efficacy of JIN-A02, the 4th generation of orally administered EGFR-TKI, in patients with EGFR mutation(+) advanced NSCLC after standard antitumor treatment including the currently approved EGFR-TKIs and platinum-based chemotherapy up to once. To evaluate DLT and to determine RP2D in patients with EGFR T790M or C797X mutation(+) advanced NSCLC who have progressed the disease after standard antitumor treatment including EGFR TKIs and platinum-based chemotherapy up to once by using BOIN (Bayesian optimal interval) design in phase 1 dose-escalation study To evaluate the safety and tolerability within 2 levels of preliminary effective dose, which have been determined by SRC, in patients with EGFR T790M or C797X mutation(+) advanced NSCLC who have progressed the disease after standard antitumor therapies including EGFR-TKIs and platinum-based chemotherapy up to once, and to evaluate safety and tolerability of JIN-A02 as a monotherapy in order to determine RP2D The subjects enrolled in the dose-escalation study will be included for evaluation at this time. In phase 2 dose-expansion study, to evaluate the antitumor activity of JIN-A02 as a monotherapy by dividing into 3 cohorts of EGFR mutation(+) patients who have progressed the disease after standard antitumor treatments including the approved EGFR-TKIs with activity against T790M, such as osimertinib, and platinum-based chemotherapy up to once. In the phase 1 study, the presence of EGFR mutation will be confirmed with the results from the plasma-based ctDNA test and/or tumor biopsy by using a method validated locally and approved by the sponsor. In the phase 2 study, the presence of C797X mutation will be confirmed with the ctDNA test from tumor tissue and/or plasma as mandatory. However, it may be submitted if the specimen has been stored after disease progression in the previous treatment.

• Phase: Phase 1/Phase 2

Details

• Lead Sponsor: J Ints Bio