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Title:
A Phase 1b, Master Protocol Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 510 in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (20190135)
Protocol Number:
J19123
Phase:
Phase I
Physician:
Kristen Marrone
Sites:
Johns Hopkins Kimmel Cancer Center in Baltimore
Purpose:
To evaluate the safety and tolerability of AMG 510 administered in investigational regimens in adult subjects with KRAS p.G12C mutant advanced solid tumors.
Eligibility:
Inclusion Criteria:•Men or women greater than or equal to 18 years old.•Pathologically documented, locally-advanced or metastatic malignancy with, KRAS p.G12Cmutation identified through molecular testing.Exclusion Criteria:•Primary brain tumor.•Active brain metastases from non-brain tumors.•Myocardial infarction within 6 months of study day 1.•Gastrointestinal (GI) tract disease causing the inability to take oral medication.
Treatment:
Sub-protocol A: AMG 510+ MEKi Experimental: AMG510 + MEK inhibitor Dose Exploration and Dose Expansion•Enrollment into the dose exploration cohort is for eligible subjects with KRAS P.G12C mutant advanced solid tumors.•Upon completing the dose exploration part of the study, dose expansion may may proceed consisting of subjects with KRAS p.G12C mutant advanced solid tumors.Sub-protocol B: AMG510+ PD1 inhibitor Experimental: AMG510 + PD-1inhibitor Dose Exploration and Dose Expansion•Enrollment into the dose exploration cohort is for eligible subjects with KRAS P.G12C mutant advanced solid tumors.•Upon completing the dose exploration part of the study, dose expansion may proceed consisting of subjects with KRAS p.G12C mutant advanced solid tumors.
Population:
Adult
Last Update
08/08/2020 05:02 AM