To evaluate safety, tolerability, PK, and preliminary efficacy of AMG 510 PO QD in subjects of Chinese descent with KRAS p.G12C-mutant advanced/metastatic solid tumors.
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Number of Participants With Dose-limiting Toxicities (DLT)
Timeframe: Day 1 to Day 21
Number of Participants With Treatment-emergent AEs (TEAEs)
Timeframe: Day 1 until the end of study (or primary data cut-off date for ongoing participants); median [min, max] duration was 5.57 [1.5, 13.7] months
Maximum Observed Plasma Concentration (Cmax) of Sotorasib
Timeframe: Pre-dose and 0.25, 0.5, 1, 2, 4, 6, and 24 hours post-dose on Days 1 and 8
Time to Achieve Cmax (Tmax) of Sotorasib
Timeframe: Pre-dose and 0.25, 0.5, 1, 2, 4, 6, and 24 hours post-dose on Days 1 and 8
Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours (AUC0-24h) of Sotorasib
Timeframe: Pre-dose and 0.25, 0.5, 1, 2, 4, 6, and 24 hours post-dose on Days 1 and 8