Phase
Condition
Lymphoma, B-cell
Lymphoma
Bone Neoplasm
Treatment
EZM0414
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Voluntarily provide signed informed consent after review of verbal and writtenmaterial about the trial and agree to abide with protocol requirements. All studyrelated activities must be carried out after written consent is obtained.
Subjects must be ≥18 years of age at the time of signing the ICF (Informed ConsentForm).
Subjects must have an Eastern Cooperative Oncology Group (ECOG) status of 0 - 2.
For MM, subjects must have measurable disease by IMWG (International Myeloma WorkingGroup) 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 intercoursewhile participating in this study
Male subjects must either practice complete abstinence or agree to use a latex orsynthetic condom, even with a successful vasectomy, during study treatment and for 30 days after the final dose of study treatment
Exclusion
Exclusion Criteria:
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 systemictreatment, including COVID-19.
Has cardiovascular impairment
Prolongation of corrected QT interval using Fridericia's formula (QTcF) to > 480msec 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 weeksprior to screening.
Current participation in any other interventional clinical study except for followup.
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 insignificant risk and affect the interpretation of toxicity and adverse eventsassessments.
Inability to take oral medication or known gastrointestinal (GI) disease, GIprocedure or medical condition that could interfere with the oral absorption ortolerance of the study drug
Study Design
Study Description
Connect with a study center
City of Hope
Duarte, California 91010
United StatesSite Not Available
Regional Cancer Care Associates LLC - Chevy Chase
Chevy Chase, Maryland 20815
United StatesSite Not Available
Dana-Farber Cancer Institute
Boston, Massachusetts 02215
United StatesSite Not Available
University of Michigan
Ann Arbor, Michigan 48109
United StatesSite Not Available
Karmanos Cancer Institute
Detroit, Michigan 48201
United StatesSite Not Available
Astera Cancer Care
East Brunswick, New Jersey 08816
United StatesSite Not Available
Regional Cancer Care Associates LLC - Freehold
Freehold, New Jersey 07728
United StatesSite Not Available
Icahn School of Medicine at Mount Sinai
New York, New York 10029
United StatesSite Not Available
Memorial Sloan-Kettering Cancer Center
New York, New York 10065
United StatesSite Not Available
Weill Cornell Medicine
New York, New York 10021
United StatesSite Not Available
Baylor University Medical Center (Texas Oncology)
Dallas, Texas 75246
United StatesSite Not Available
MD Anderson Cancer Center
Houston, Texas 77030
United StatesSite Not Available
NEXT Virginia
Fairfax, Virginia 22031
United StatesSite Not Available
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin 53215
United StatesSite Not Available
Medical College of Wisconsin
Milwaukee, Wisconsin 53226
United StatesSite Not Available
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