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A Phase 1 Study of AG-636 in the Treatment of Subjects With Advanced Lymphoma
The purpose of this Phase 1, multicenter, open-label study is to determine the maximum tolerated dose (MTD) of AG-636 and characterize its dose-limiting toxicities (DLTs) when given by mouth to subjects with advanced lymphoma that is refractory to standard treatment. During the dose escalation part of the study successive cohorts of subjects will be treated with increasing doses of AG-636 in order to determine its maximum tolerated dose (MTD). Subsequently, in the dose expansion part of the study, additional subjects will be treated at the MTD in order to confirm that dose's safety, tolerability, PK and PD, and to provide an opportunity to detect anti-lymphoma activity. The dose expansion part of the study will support the selection of a dose for future clinical studies (a recommended Phase 2 dose [RP2D]).
Primary Objective: To determine the maximum tolerated dose (MTD) of AG-636 and characterize its dose-limiting toxicities (DLTs) when given to subjects with advanced lymphoma Secondary Objectives: To characterize the safety and tolerability of AG-636 To characterize the pharmacokinetics (PK) of AG-636 and its metabolite AGI-0045653 in plasma To characterize the pharmacodynamics (PD) of AG-636 by assessing plasma concentrations of DHO To characterize any anti-lymphoma activity that may be associated with AG-636 treatment