A Study in Subjects With Relapsed/Refractory Multiple Myeloma and Relapsed/Refractory Diffuse Large B-Cell Lymphoma EZM0414

What's the purpose of this trial?

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).

This trial is currently open and accepting patients.

What will happen during the trial?

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.

 

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

Inclusion Criteria:

  • 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 ≥18 years of age at the time of signing the ICF (Informed Consent Form).
  • Subjects must have an Eastern Cooperative Oncology Group status of 0 or 1.
  • 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 have had either a successful vasectomy OR they and their female partner must meet the criteria above ie, not of childbearing potential OR practicing highly effective contraception and use a condom throughout the study period

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 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

Additional Trial Information

Phase 1

Enrollment: 96 patients (estimated)

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Trial Links

Read the latest news and updates on this trial.

Epizyme Receives Fast Track Designation from U.S. FDA and Announces Initiation of Phase 1/1b Study of its Novel SETD2 Inhibitor, EZM0414

November 04, 2021

Epizyme, Inc., a fully integrated, commercial-stage biopharmaceutical company developing and delivering novel epigenetic therapies, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to EZM0414, the Company’s novel, first-in-class, oral SETD2 inhibitor, as an investigational agent for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).

Read more

Trial Locations

All Trial Locations

View all clinical trial locations sorted by state.

Massachusetts

Dana-Farber Cancer Institute (Main)

Boston, MA

Not Yet Accepting

Michigan

Barbara Ann Karmanos Cancer Institute Wayne State University

Detroit, MI

Open and Accepting

New York

Memorial Sloan Kettering Cancer Center

New York, NY

Open and Accepting

Weill Cornell

New York, NY

Open and Accepting

Mount Sinai Hospital Tisch Cancer Institute

New York, NY

Open and Accepting

Texas

Baylor Charles A. Sammons Cancer Center Baylor Scott & White Health

Dallas, TX

Open and Accepting

MD Anderson Cancer Center The University of Texas

Houston, TX

Open and Accepting
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