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

NCT06186076 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2026-04-02

No results posted yet for this study

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).

Conditions

  • Carcinoma, Non-Small-Cell Lung
  • EGFR Mutant Advanced Non-Small Cell Lung Cancer

Interventions

DRUG

TRX-221

TRX-221 oral dose as defined

Sponsors & Collaborators

  • Therapex Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Therapex Co., Ltd Clinical Development · Therapex Co., Ltd: Clinical Development

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-14
Primary Completion
2025-12-03
Completion
2025-12-03
FDA Drug
Yes

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06186076 on ClinicalTrials.gov