Status:
RECRUITING
A Study to Investigate Safety, Tolerability, PK and Anti-tumor Activity of TRX-221 in EGFRm NSCLC Patients
Lead Sponsor:
Therapex Co., Ltd
Conditions:
Carcinoma, Non-Small-Cell Lung
EGFR Mutant Advanced Non-Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 prog...
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 cri...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
Key Trial Info
Start Date :
June 14 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2028
Estimated Enrollment :
115 Patients enrolled
Trial Details
Trial ID
NCT06186076
Start Date
June 14 2024
End Date
June 30 2028
Last Update
June 26 2024
Active Locations (6)
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1
Seoul National University Bundang Hospital
Seongnam, Kyeongki, South Korea, 13620
2
The Catholic University of Korea St. Vincent Hospital
Suwon, Kyeongki, South Korea, 16247
3
Chungbuk National University Hospital
Chungju, North Chungcheong, South Korea, 28644
4
Severance Hospital
Seoul, South Korea, 03722