A Phase 1/2, Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of Sotorasib (AMG 510) Monotherapy in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation and Sotorasib (AMG 510) Combination Therapy in Subjects With Advanced NSCLC With KRAS p.G12C Mutation (CodeBreaK 100)
A Phase 1/2, Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of Sotorasib (AMG 510) Monotherapy in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation and Sotorasib (AMG 510) Combination Therapy in Subjects With Advanced NSCLC With KRAS p.G12C Mutation (CodeBreaK 100)
Evaluate the safety and tolerability of sotorasib in adult subjects with KRAS p.G12C mutant advanced solid tumors.
Estimate the maximum tolerated dose (MTD) and/or a recommended phase 2 dose (RP2D) in adult subjects with KRAS p.G12C mutant advanced solid tumors.
Inclusion Criteria:
Exclusion Criteria
Newark, Delaware 19713, United States
New York, New York 10016, United States
Pittsburgh, Pennsylvania 15232, United States
Spartanburg, South Carolina 29303, United States
Porto Alegre, Rio Grande do Sul 90050-170, Brazil
Porto Alegre, Rio Grande do Sul 90610-000, Brazil
Heraklion - Crete, 71500, Greece
Kashiwa-shi, Chiba 277-8577, Japan
Kawasaki-shi, Kanagawa 216-8511, Japan
Hirakata-shi, Osaka 573-1191, Japan
Sunto-gun, Shizuoka 411-8777, Japan
Koto-ku, Tokyo 135-8550, Japan
Lisbon, 1769-001, Portugal
Matosinhos Municipality, 4464-513, Portugal
Goyang-si Gyeonggi-do, 10408, South Korea
Seongnam-si, Gyeonggi-do, 13620, South Korea