Assessing an Oral EGFR Inhibitor,YK-209A in Patients Who Have Advanced Non-small Cell Lung Cancer With EGFR

Phase 1/2 Unknown 160 enrolled Suzhou Puhe Pharmaceutical Technology Co., LTD

Non-randomizedParallel-groupOpen-labelTreatment

Summary

This study aimed to evaluate the safety and preliminary efficacy of YK-029A, a novel third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor, in treated or untreated patients with advanced non-small cell lung cancer (NSCLC).

Timeline

Start: 2018-03-30
Primary completion: 2023-12-30
Completion: 2024-05-30

Publications

Duan J, Wu L, Yang K, Zhao J, Zhao Y, Dai X, Li M, Xie Y, Yao Y, Zhao M, Zhou C, Ren X, Liu Z, Pan Y, Li Y, Liu B, Cheng Y, Miao L, Yu Q, Zhang Z, Liu X, Cui J, Zhang Y, Zhang L, Li X, Li X, Shen B, Chen B, Zeng S, Li B, Hu Y, Li L, Wu R, Song Q, Wang J. Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of YK-029A in Treatment-Naive Patients With Advanced NSCLC Harboring EGFR Exon 20 Insertion Mutations: A Phase 1 Trial. J Thorac Oncol. 2024 Feb;19(2):314-324. doi: 10.1016/j.jtho.2023.09.1449. Epub 2023 Sep 28.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	YK-029A	Unknown	50 mg	Oral
Subject	YK-029A	Unknown	100 mg	Oral
Subject	YK-029A	Unknown	150 mg	Oral
Subject	YK-029A	Unknown	200 mg	Oral
Subject	YK-029A	Unknown	250 mg	Oral

Indications

No indication recorded.