Trial Identifiers
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Scientific Title
Phase 1 Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 596 in Subjects With Glioblastoma Expressing Mutant Epidermal Growth Factor Receptor Variant III (EGFRvIII)
Commercial Sponsor
AMGEN
Summary
This is a Phase 1 Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 596 in Subjects with Glioblastoma Expressing Mutant Epidermal Growth Factor Receptor Variant III (EGFRvIII). This is a first in human (FIH), open-label, sequential-dose-escalation study in subjects with EGFRvIII-positive glioblastoma. This study will enroll 2 groups of subjects according to disease stage, recurrent disease (Group 1) and maintenance treatment after SoC in newly diagnosed disease (Group 2).