NCT06186076TerminatedPhase 1/2

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

Source: ClinicalTrials.gov · Last updated 2 Apr 2026

Reason given: Sponsor's decision

Brief summary (registry, in English)

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).

Status (registry): Terminated
Phase (registry): Phase 1/2
Study type: Interventional
Enrollment: 19 (actual)
First submitted: 6 Dec 2023
Start date: 14 Jun 2024
Primary completion date: 3 Dec 2025
Lead sponsor: Therapex Co., Ltd
Diseases: Lung cancer
NCT number: NCT06186076

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

Patients with presence of another active primary malignant tumor that has been diagnosed or required therapy within 2 years prior to the initiation of the study treatment
Patients having any unresolved toxicities from prior anti tumor therapy and surgery greater than CTCAE Grade 1 at the time of starting the study treatment

Other illness

Clinically significant cardiac conditions, infections, refractory GI diseases as specified in the protocol

Lab values

Recent anticancer therapy: EGFR-TKI, Immunotherapy or any other systemic anticancer therapy or radiotherapy (specific duration prior to starting study medication per protocol)

Other

NSCLC with mixed cell histology or a tumor with histologic transformation of small cell elements
Patients having tumor with any additional known driver of alterations
Patients who have unstable and symptomatic primary CNS tumors/metastasis, leptomeningeal metastases or spinal cord compression which are not suitable for enrollment, as judged by the Investigator
Patients having clinically active ongoing ILD of any etiology

Who the study is looking for

Patients with ECOG performance status score of 0 or 1
Histologically or cytologically confirmed diagnosis of relapsed or refractory, locally unresectable advanced or metastatic NSCLC harboring an activating EGFR mutation
Failed standard of care treatments progressed after anti tumor treatments including at least 1 approved EGFR TKI [Phase2: TKIs should include the approved EGFR TKIs with activity against T790M (e.g., osimertinib)]
Slots may be reserved for patients with certain resistant mutations (i.e., EGFR C797X mutation with or without T790M mutation as required by the sponsor) [Phase 1]
EGFR C797X mutation with or without T790M mutation [Phase 2]
Not received more than 1 prior line of platinum based chemotherapy in the metastatic setting [Phase 2]
Having at least 1 measurable tumor lesion per RECIST v1.1 criteria [Phase 2]
Having adequate bone marrow, hepatic, and renal function as specified in the protocol

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (6)

Sites in registry order. Save your city in your profile to sort them by distance.

Site	City	Country	Site status
Chungbuk National University Hospital	Chungju	South Korea	Unknown status
Seoul National University Bundang Hospital	Seongnam	South Korea	Unknown status
Asan Medical Center	Seoul	South Korea	Unknown status
Severance hospital	Seoul	South Korea	Unknown status
Samsung Medical Center	Seoul	South Korea	Unknown status
The Catholic University of Korea St. Vincent Hospital	Suwon	South Korea	Unknown status

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This page is information, not medical advice. Discuss any trial with your doctor.