This trial is a multi-center, single-arm, open-label, Phase I clinical trial in 3 phases: dose escalation phase, dose expansion phase and indication expansion phase, which will explore the safety, tolerability, PK and preliminary efficacy of TGRX-326 in patients with ALK-positive or ROS1-positive advanced NSCLC.
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Maximal tolerated dose (MTD)
Timeframe: At end of Cycle 1 (each cycle is 21 days) when the probability of DLT of a dose level is higher than 33%
Recommended phase II dose (RP2D)
Timeframe: At completion of the dose expansion study, an average of 1 year
Safety profile (DLT)
Timeframe: Collect during Cycle 1 (each cycle is 21 days)
Safety profile (AEs/SAEs)
Timeframe: Through completion of the study, an average of 1.5 years