A Phase 1/2, Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of AMG 510 Monotherapy in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation and AMG 510 Combination Therapy in Subjects With Advanced NSCLC With KRAS p.G12C Mutation (Codebreak 100)
Evaluate the safety and tolerability of AMG 510 in adult patients with KRAS p.G12C mutant advanced solid tumors. Estimate the maximum tolerated dose (MTD) and/or a recommended phase 2 dose (RP2D) in adult patients with KRAS p.G12C mutant advanced solid tumors.
Participating only in Phase II; Phase II Primary Objectives To evaluate tumor objective response rate (ORR), assessed by RECIST 1.1 criteria, of AMG 510 as monotherapy in subjects with KRAS p.G12C mutant advanced solid tumors(NSCLC, colorectal cancer [CRC], and other tumor types). Secondary Objectives: To evaluate other measures of AMG 510 efficacy as monotherapy in subjects with KRAS p.G12C mutant advanced solid tumors by RECIST 1.1 (NSCLC, CRC, and other tumor types): Duration of response (DOR), disease control rate (DCR), time to response (TTR), progression-free survival (PFS), overall survival (OS), PFS rate at 6 months and 12 months, OS rate at 12 months. To evaluate the safety and tolerability of AMG 510 in adult subjects with KRAS p.G12C mutant advanced solid tumors (NSCLC, CRC, and other tumor types). To evaluate the PK of AMG 510 following administration as an oral tablet formulation.
Immunotherapy; Therapy (NOS)
AMG 510 (); Pembrolizumab (Keytruda)
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