Arms |
Assigned Interventions |
Experimental:Dose Exploration Part 1 monotherapy
Cohorts with food effect and alternative dosing regimens
Enrollment into the dose exploration cohorts may be from any eligible solid tumor type. Dose escalation will begin with 2-4 subjects treated at the lowest planned dose level of 180 mg. If no DLT is observed, dose escalation will continue to the next planned dose cohort
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Experimental:Dose Expansion Part 2 monotherapy
Upon completing the dose exploration part of the study, dose expansion may proceed with 3 groups consisting of subjects with KRAS p.G12C mutant advanced solid tumors Dose expansion in these 3 groups may be done concurrently
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Experimental:Phase 2 monotherapy
Additional subjects will be enrolled in the dose expansion to confirm the recommended phase 2 dose. Enrollment into phase 2 will be opened after confirmation of the recommended phase 2 dose
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Experimental:Combination arm with AMG 510 and anti PD-1/L1
Additional subjects will be enrolled into the combination arm with AMG 510 in combination with an anti (PD-1/L1)
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Drug:AMG 510 Characterize the pharmacokinetics (PK) of AMG 510 following administration as an oral Tablet formulation |
Experimental:Monotherapy treatment naive advanced NSCLC
Separate cohort of part 1 dose expansion patients to evaluate the safety and clinical activity of AMG 510 administered orally once daily in patients with previously untreated advanced NSCLC
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