RecruitingPhase 1Phase 2NCT06186076

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

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

Sponsor

Therapex Co., Ltd

Enrollment

115 participants

Start Date

Jun 14, 2024

Study Type

INTERVENTIONAL

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).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new drug called TRX-221 in people with advanced or metastatic non-small cell lung cancer (NSCLC) that has a specific genetic mutation in the EGFR gene. The drug targets cancer cells that have developed resistance to existing EGFR-targeting drugs (TKIs). **You may be eligible if...** - You have been diagnosed with advanced or metastatic non-small cell lung cancer - Your tumor has a confirmed activating EGFR mutation - You have already tried at least one approved EGFR-targeting drug (TKI) and your cancer has progressed - You are in good enough health to participate (ECOG performance status 0 or 1) **You may NOT be eligible if...** - You have not yet tried any EGFR-targeted therapy - You have active brain metastases that are unstable - You have serious heart, liver, or lung problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTRX-221

TRX-221 oral dose as defined

Locations(6)

Seoul National University Bundang Hospital

Seongnam, Kyeongki, South Korea

The Catholic University of Korea St. Vincent Hospital

Suwon, Kyeongki, South Korea

Chungbuk National University Hospital

Chungju, North Chungcheong, South Korea

Severance Hospital

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

View Full Details on ClinicalTrials.gov

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NCT06186076