A Study of TPX-0131, a Novel Oral ALK Tyrosine Kinase Inhibitor, in Patients With ALK+ Advanced or Metastatic NSCLC

Inclusion Criteria: * Age ≥ 18 (or as required by local regulation). * Histological or cytological confirmation of advanced/metastatic ALK+ NSCLC. * Pretreated with up to three prior lines of an ALK TKI treatment, including at least one prior line of a second or third-generation ALK TKI (alectinib, brigatinib, ensartinib, or lorlatinib) in Phase 1. * ECOG performance status ≤ 1. * Existence of measurable or evaluable disease (according to Response evaluation criteria in solid tumors \[RECIST v1.1\] criteria). * Subjects with asymptomatic CNS metastases and/or asymptomatic leptomeningeal carcinomatosis are eligible. * Adequate organ function. Exclusion Criteria: * Major surgery within four weeks of the start of TPX-0131 treatment. * Clinically significant cardiovascular disease * Any of the following cardiac criteria: * Mean resting corrected QT interval (QTc) \> 470 msec obtained from three ECGs and any factors that increase the risk of QTc prolongation or arrhythmic events * Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG * Known clinically significant active infections not controlled with systemic treatment (bacterial, fungal, viral including HIV positivity). * Gastrointestinal disease or other malabsorption syndromes that would impact drug absorption. * Subjects being treated with or anticipating the need for treatment with strong CYP3A4 inhibitors or inducers. * Subjects with current or anticipated need for drugs that are sensitive CYP2C9 substrates with narrow therapeutic indices.