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A Study to Investigate Safety, Tolerability, PK and Anti-tumor Activity of TRX-221 in EGFRm NSCLC Patients

Carcinoma, Non-Small-Cell Lung Clinical Trial

Official title:
An Open Label, Multicenter, Phase 1/2 Study to Explore the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of TRX-221 in the Treatment of Patients With EGFR Mutant NSCLC Who Progressed Following Prior Therapy With EGFR TKI

Clinical Trial Summary

This is a Phase 1/2, open-label study designed to investigate the safety, tolerability, PK, and anti-tumor activity of the study treatment in the treatment of patients with EGFR mutant NSCLC, who progressed following prior standard treatments which include the approved EGFR-TKIs with activity against T790M (e.g., osimertinib).

Clinical Trial Description

All eligible patients will receive the study treatment at selected oral dose(s) once daily. Patients will be treated continuously until disease progression or any other pre-defined discontinuation criteria are met. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06186076
Study type Interventional
Source Therapex Co., Ltd
Contact Therapex Co., Ltd Clinical Development
Phone +82263203300
Email TRX-221ClinicalDevelopment@therapexbio.com
Status Not yet recruiting
Phase Phase 1/Phase 2
Start date April 30, 2024
Completion date June 30, 2028
View Details
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