Carcinoma, Non-Small-Cell LungPhase 1/2NCT06186076
A Study to Investigate Safety, Tolerability, PK and Anti-tumor Activity of TRX-221 in EGFRm NSCLC Patients
A Phase 1/2 study testing TRX-221 in people with Carcinoma, Non-Small-Cell Lung and EGFR Mutant Advanced Non-Small Cell Lung Cancer, run by Therapex Co., Ltd at 6 sites in South Korea.
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.… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung, EGFR Mutant Advanced Non-Small Cell Lung Cancer
- What is being tested?
- TRX-221
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 6 sitesSouth Korea
- Study dates
- 14 Jun 2024to 3 Dec 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 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 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
- Clinically significant cardiac conditions, infections, refractory GI diseases as specified in the protocol
- 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
- Recent anticancer therapy: EGFR-TKI, Immunotherapy or any other systemic anticancer therapy or radiotherapy (specific duration prior to starting study medication per protocol)
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
South Korea6 sites
Chungbuk National University Hospital
Chungju, North Chungcheong, 28644
Seoul National University Bundang Hospital
Seongnam, Kyeongki, 13620
Severance Hospital
Seoul, 03722
Asan Medical Center
Seoul, 05505
Samsung Medical Center
Seoul, 06351
The Catholic University of Korea St. Vincent Hospital
Suwon, Kyeongki, 16247
About this study
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
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).
Read the detailed 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.
- Being tested
- TRX-221
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRX-221Drug
TRX-221 oral dose as defined
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 Part A: Dose escalation in patients with EGFR sensitizing mutation | Experimental | All eligible patients will receive the study treatment at selected oral dose(s) once daily, as per the assigned dose level from the pre-defined escalation scheme and SRC(Safety Review Committee) decision. Receives: Drug: TRX-221 |
| Phase 1 Part B: 2 dose levels of TRX-221 in patients with EGFR sensitizing mutation | Experimental | All eligible patients will receive the study treatment at selected oral dose(s) once daily. Dose-levels will be selected from the Part A. Receives: Drug: TRX-221 |
| Phase 2: Recommended Phase 2 dose(s) of TRX-221 in patients with EGFR C797X mutation | Experimental | All eligible patients will receive the study treatment at selected oral dose(s) once daily. Receives: Drug: TRX-221 |
What is being measured
The primary outcome is the main question the study is designed to answer.
[Phase1 PartA: Dose Escalation] To assess the safety/tolerability and determine the MTD/RP2D range of TRX-221
Incidence and severity of AEs graded according to the NCI-CTCAE v5.0 Number and percentage of patients with TEAEs, SAEs, and DLTs Safety and tolerability as noted by laboratory data, vital signs, physical examinations, and 12-lead ECGs
Measured: Approx. 12 months
[Phase1 PartB: Dose Exploration] To determine the RP2D of TRX-221
Incidence and severity of AEs, TEAEs, SAEs Safety and tolerability as noted by laboratory data, vital signs, physical examinations, and 12-lead ECGs
Measured: Approx. 6-12 months
[Phase2] To assess the anti-tumor activity of TRX-221 in patients with the selected EGFR-resistant mutation type
Tumor response rate (ORR)
Measured: Approx. 6-12 months
Secondary outcomes (4)
To characterize the PK profile of the study treatment
Peak Plasma Concentration (Cmax)
Measured: Throughout the study period, an average of 1 year
To evaluate the preliminary anti-tumor activity of the study treatment (Phase 1)
ORR
Measured: Approx. 12 months
To evaluate additional anti-tumor activity of the study treatment other than the primary endpoint (Phase 2)
PFS
Measured: Approx. 12 months
To assess the safety and tolerability of the study treatment (Phase 2)
Incidence and severity of AEs, TEAEs, SAEs Safety and tolerability as noted by laboratory data, vital signs, physical examinations, and 12-lead ECGs
Measured: Approx. 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2023
- Study start14 Jun 2024
- Primary completion3 Dec 2025
- Study completion3 Dec 2025
Why it stopped: Sponsor's decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Therapex Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Therapex Co., Ltd Clinical Development, Study director, Therapex Co., Ltd: Clinical Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06186076
- Sponsor's protocol ID
- TRX-221-001
- Status last verified
- Mar 2026
- First submitted
- 6 Dec 2023
- Last updated
- 2 Apr 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06186076
- Acronym / sponsor ID
- TRX-221-001
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor's decision
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Therapex Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 14 Jun 2024 (actual)
- Primary completion
- 3 Dec 2025 (actual)
- Study completion
- 3 Dec 2025 (actual)
- First posted
- 29 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phase 1 Part A: Dose escalation in patients with EGFR sensitizing mutation | Experimental | Drug: TRX-221All eligible patients will receive the study treatment at selected oral dose(s) once daily, as per the assigned dose level from the pre-defined escalation scheme and SRC(Safety Review Committee) decision. |
| Phase 1 Part B: 2 dose levels of TRX-221 in patients with EGFR sensitizing mutation | Experimental | Drug: TRX-221All eligible patients will receive the study treatment at selected oral dose(s) once daily. Dose-levels will be selected from the Part A. |
| Phase 2: Recommended Phase 2 dose(s) of TRX-221 in patients with EGFR C797X mutation | Experimental | Drug: TRX-221All eligible patients will receive the study treatment at selected oral dose(s) once daily. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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]
Key exclusion criteria (8 listed)
- 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 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 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TRX-221TRX-221 oral dose as defined | Drug | Phase 1 Part A: Dose escalation in patients with EGFR sensitizing mutation, Phase 1 Part B: 2 dose levels of TRX-221 in patients with EGFR sensitizing mutation, Phase 2: Recommended Phase 2 dose(s) of TRX-221 in patients with EGFR C797X mutation |
Primary outcome
[Phase1 PartA: Dose Escalation] To assess the safety/tolerability and determine the MTD/RP2D range of TRX-221
Time frame: Approx. 12 months
Incidence and severity of AEs graded according to the NCI-CTCAE v5.0 Number and percentage of patients with TEAEs, SAEs, and DLTs Safety and tolerability as noted by laboratory data, vital signs, physical examinations, and 12-lead ECGs
[Phase1 PartB: Dose Exploration] To determine the RP2D of TRX-221
Time frame: Approx. 6-12 months
Incidence and severity of AEs, TEAEs, SAEs Safety and tolerability as noted by laboratory data, vital signs, physical examinations, and 12-lead ECGs
[Phase2] To assess the anti-tumor activity of TRX-221 in patients with the selected EGFR-resistant mutation type
Time frame: Approx. 6-12 months
Tumor response rate (ORR)
4 secondary outcomes
To characterize the PK profile of the study treatment
Time frame: Throughout the study period, an average of 1 year
To evaluate the preliminary anti-tumor activity of the study treatment (Phase 1)
Time frame: Approx. 12 months
To evaluate additional anti-tumor activity of the study treatment other than the primary endpoint (Phase 2)
Time frame: Approx. 12 months
To assess the safety and tolerability of the study treatment (Phase 2)
Time frame: Approx. 12 months
Results and safety
The study was stopped early (reason given: Sponsor's decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Therapex Co., Ltd Clinical Development study director
Therapex Co., Ltd: Clinical Development
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing TRX-221 in people with Carcinoma, Non-Small-Cell Lung and EGFR Mutant Advanced Non-Small Cell Lung Cancer, run by Therapex Co., Ltd at 6 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Sponsor's decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
[Phase1 PartA: Dose Escalation] To assess the safety/tolerability and determine the MTD/RP2D range of TRX-221 (time frame: Approx. 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2026.