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Clinical Trial 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).


Clinical Trial Description

This phase 1/2 study will evaluate the safety, pharmacokinetics, and anti-tumor activity of oral EGFR Inhibitor YK-209A in participants with NSCLC and anti-tumor activity of YK-029A in participants with solid tumors other than NSCLC harboring ex20ins, T790M or rare mutations. The trial will be conducted in three parts: a dose escalation (Part 1), expansion phase (Part 2), followed by an extension phase (Part 3). The objectives of the dose escalation phase (Part 1), is to determine the safety profile of orally administered YK-029A, including the MTD, DLTs, RP2D, pharmacokinetic profile. The primary goal of the expansion component of the trial is to evaluate the anti-tumor activity of YK-029A in nine histologically and molecularly defined cohorts at the RP2D (determined based on dose escalation phase of the trial). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05767866
Study type Interventional
Source Suzhou Puhe Pharmaceutical Technology Co., LTD
Contact Hui Zhao, Doctor
Phone +8618911018556
Email zh@puhebiopharma.com
Status Recruiting
Phase Phase 1/Phase 2
Start date March 30, 2018
Completion date May 30, 2024

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