SEOUL, South Korea, Sept. 13, 2023 /PRNewswire/ -- J INTS BIO announced that Phase 1/2 study of its novel, orally administered 4th generation EGFR-TKI 'JIN-A02' was presented at the 2023 IASLC World Conference on Lung Cancer held in Singapore from 9th to 12th September, during the official session entitled 'Metastatic Non-small Cell Lung Cancer – Targeted Therapy - EGFR/HER2'..

韩国首尔，2023年9月13日/PRNewswire/--J INTS BIO宣布，其新型口服第4代EGFR-TKI'JIN-A02'的1/2期研究于2023年IASLC世界会议上发表9月9日至12日在新加坡举行的题为“转移性非小细胞肺癌靶向治疗-EGFR/HER2”的官方会议期间，肺癌。。

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Professor Cho, Byoung Chul, poster presentation of Phase 12 study of its Novel Oral 4th Generation EGFR-TKI ‘JIN-A02’ at the WorldConference on Lung Cancer in Singapore (IASLC 2023 WCLC)

Cho教授Byoung Chul在新加坡世界肺癌会议（IASLC 2023 WCLC）上展示其新型口服第4代EGFR-TKI'JIN-A02'的12期研究海报

JIN-A02, a 4th generation EGFR TKI, selectively and reversibly binds to EGFR mutations, in particular C797S mutation that led to resistance to Osimertinib therapy. In preclinical studies, JIN-A02 has demonstrated potent activities as monotherapy in models with EGFR mutations that are resistant to Osimertinib..

第四代EGFR TKI的JIN-A02选择性和可逆地结合EGFR突变，特别是导致对Osimertinib治疗耐药的C797S突变。在临床前研究中，JIN-A02已证明在对Osimertinib耐药的EGFR突变模型中作为单一疗法具有强大的活性。。

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.

这项全球1/2期临床研究旨在评估“JIN-A02”在携带EGFR突变的晚期NSCLC患者中的安全性，药代动力学和抗肿瘤活性。

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.

本研究分为剂量递增（A部分），剂量探索（B部分）和剂量扩展（C部分）三部分。A部分探讨了28天周期内口服JIN-A02单药治疗的递增剂量，以评估携带C797S或T790M突变的晚期NSCLC患者的最大耐受剂量。

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 11th of September 2023, a total of three subjects have completed MTD evaluation period for Dose Level One of Part A.

根据A部分获得的结果，安全审查委员会将选择2个剂量，在B部分进一步评估，通过确定安全性，药代动力学和疗效，与A部分相同，尽管在更大的患者队列中。一旦确定了推荐的第2阶段剂量（RP2D），C部分剂量扩展研究将从基于EGFR突变和脑转移状态的五组患者开始。第一例JIN-A02患者的剂量已于2023年7月实现，截至2023年9月11日，共有三名受试者完成了a部分剂量水平之一的MTD评估期。

There was no DLT, no treatment related AE, and no clinical disease progression was noted.SOURCE J INTS BIO.

没有DLT，没有治疗相关的AE，也没有注意到临床疾病进展。来源J INTS BIO。