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An Open-Label, Multicenter, Phase 1/2 Study of E7438 (EZH2 Histone Methyl Transferase [HMT] Inhibitor) as a Single Agent in Subjects With Advanced Solid Tumors or With B-cell Lymphomas
This is a multicenter, open-label, Phase 1/2 study that is being conducted in two parts. The Phase 1 portion comprises dose escalation and establishment of the recommended Phase 2 dose (RP2D) when EPZ-6438 (E7438) is given BID (twice daily) orally on a continuous basis. Additionally, in separate cohorts in Phase 1, the effect of food on the bioavailability of EPZ-6438 as well as the drug-drug interaction (DDI) potential of EPZ-6438 are being evaluated. When maximum tolerated dose (MTD) has been identified and the RP2D confirmed, the Phase 2 portion will enroll subjects that have relapsed/refractory diffuse large B-cell lymphoma (DLBCL) or follicular lymphomas (FL) that have either mutant or wild-type EZH2.