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A Study of TY-9591 in Advanced Non-small Cell Lung Cancer(NSCLC) Patients With EGFR Positive Mutation

NSCLC Clinical Trial

Official title:
Phase I, Open-label, Single-arm Study to Evaluate the Safety, Tolerance, Pharmacokinetics and Preliminary Efficacy of TY-9591 Tablets in Advanced NSCLC Patients With Epidermal Growth Factor Receptor( EGFR) Positive Mutation

Clinical Trial Summary

The primary objective of this study is to evaluate the safety and tolerability of TY-9591, with dose-escalation stage and dose-expansion stage.

Clinical Trial Description

- To define the maximum tolerated dose(MTD) and the recommended phase 2 dose (RP2D) - To investigate the pharmacokinetic profile of TY-9591 and its metabolites after single then multiple doses of TY-9591 administered orally once daily - To evaluate the anti-cancer activity of TY-9591 in NSCLC patients with EGFR mutation(ORR、PFS、DoR、DCR、and CBR) ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04204473
Study type Interventional
Source TYK Medicines, Inc
Contact
Status Completed
Phase Phase 1
Start date May 7, 2020
Completion date May 18, 2023
View Details
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