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Clinical Trial Summary

This is a first-in-human (FIH), 2-part, open-label, multi-center, Phase 1/1b safety, tolerability, pharmacokinetics (PK), and efficacy study of oral SETD2 inhibitor, EZM0414, in subjects with relapsed/refractory (R/R) Multiple Myeloma (MM) and R/R Diffuse Large B-Cell Lymphoma (DLBCL).


Clinical Trial Description

The first part of the study will be a Phase 1 dose-escalation study designed to evaluate the safety, tolerability, and PK of EZM0414 in subjects with R/R MM and R/R DLBCL. Six dose levels of 100 mg, 200 mg, 300 mg, 400 mg, 600 mg, and 900 mg will be tested. The second part of the study is the Phase 1b dose expansion at the MTD designed to evaluate safety and efficacy in subjects with R/R DLBCL and R/R MM with or without select genetic translocation. Dose expansion will enroll subjects in 3 cohorts: Cohort 1 for R/R MM subjects with t(4;14), cohort 2 for R/R MM subjects without t(4;14), and Cohort 3 for subjects with R/R DLBCL. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05121103
Study type Interventional
Source Epizyme, Inc.
Contact Medical Lead, MD
Phone (855) 500-1011
Email [email protected]
Status Not yet recruiting
Phase Phase 1
Start date November 30, 2021
Completion date June 27, 2025

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