Multiple Myeloma Clinical Trial
A Study of the Safety, Tolerability and Effectiveness of EZM0414 Investigative Product in Participants With Relapsed/Refractory Multiple Myeloma and Relapsed/Refractory Diffuse Large B Cell Lymphoma
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).
The first part of the study will be a Phase 1 dose-escalation designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of EZM0414 in subjects with R/R MM and R/R DLBCL.
Six dose levels starting at 100 mg, then 200 mg, 300 mg, 400 mg, 600 mg, and 900 mg as well as an optional step-down dose of 75 mg (if needed) 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.
Voluntarily provide signed informed consent after review of verbal and written material about the trial and agree to abide with protocol requirements. All study related activities must be carried out after written consent is obtained.
Subjects must be â‰¥18 years of age at the time of signing the ICF (Informed Consent Form).
Subjects must have an Eastern Cooperative Oncology Group (ECOG) status of 0 - 2.
For MM, subjects must have measurable disease by IMWG (International Myeloma Working Group) 2016 criteria
For DLBCL, subjects must have measurable disease by Lugano criteria
Females must not be breastfeeding or pregnant at screening
Females of childbearing potential must not have had unprotected sexual intercourse while participating in this study
Male subjects must either practice complete abstinence or agree to use a latex or synthetic condom, even with a successful vasectomy, during study treatment and for 30 days after the final dose of study treatment
Subjects with plasma cell leukemia defined as a plasma cell count >2000/mm3.
Subjects with Waldenstrom's macroglobulinemia or smoldering MM.
Subjects who had prior treatment with SETD2 or NSD2 inhibitor.
Subjects with active acute or chronic systemic infection requiring systemic treatment, including COVID-19.
Has cardiovascular impairment
Prolongation of corrected QT interval using Fridericia's formula (QTcF) to > 480 msec or history of long QT syndrome.
Known left ventricular ejection fraction (LVEF) < 50% by either echocardiogram (ECHO) or multigated acquisition (MUGA).
Prior major surgery within 4 weeks of treatment start.
Known hypersensitivity to components of the investigational product.
Subjects who have received treatment with any unapproved drug product within 4 weeks prior to screening.
Current participation in any other interventional clinical study except for follow up.
Subjects with a history of or active malignancy other than disease under study
Underlying medical/social conditions that in PI opinion will place the subject in significant risk and affect the interpretation of toxicity and adverse events assessments.
Inability to take oral medication or known gastrointestinal (GI) disease, GI procedure or medical condition that could interfere with the oral absorption or tolerance of the study drug
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There are 12 Locations for this study
Chevy Chase Maryland, 20815, United States More Info
Boston Massachusetts, 02215, United States More Info
Detroit Michigan, 48201, United States More Info
East Brunswick New Jersey, 08816, United States More Info
Freehold New Jersey, 07728, United States More Info
New York New York, 10021, United States More Info
New York New York, 10029, United States More Info
New York New York, 10065, United States
Dallas Texas, 75246, United States More Info
Houston Texas, 77030, United States More Info
Fairfax Virginia, 22031, United States More Info
Milwaukee Wisconsin, 53215, United States More Info
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