[Translation] A Phase I/IIa, open-label, multicenter, dose-escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of PH009-1 in patients with locally advanced or metastatic non-small cell lung cancer who are EGFR mutation-positive
I期:主要目的:评价PH009-1安全性和耐受性,并确定最大耐受剂量(MTD)或RP2D;次要目的:评价PH009-1单次和多次口服给药后的药代动力学(PK)特征;评价PH009-1口服给药的初步抗肿瘤活性,等; IIa期:主要目的:评价选定剂量的PH009-1口服给药的初步抗肿瘤活性及选定剂量PH009-1口服给药的安全性;次要目的:进一步评价选定剂量的PH009-1口服给药的抗肿瘤活性及选定剂量的PH009-1口服给药PK特征,等;
[Translation] Phase I: Primary purpose: to evaluate the safety and tolerability of PH009-1 and determine the maximum tolerated dose (MTD) or RP2D; Secondary purpose: to evaluate the pharmacokinetic (PK) characteristics of PH009-1 after single and multiple oral administration; to evaluate the preliminary anti-tumor activity of PH009-1 after oral administration, etc.; Phase IIa: Primary purpose: to evaluate the preliminary anti-tumor activity of PH009-1 after oral administration at a selected dose and the safety of PH009-1 after oral administration at a selected dose; Secondary purpose: to further evaluate the anti-tumor activity of PH009-1 after oral administration at a selected dose and the PK characteristics of PH009-1 after oral administration at a selected dose, etc.;