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

Korábbi kezelés

• 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

Más betegség

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

Laborértékek

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

Egyéb

• 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

• 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