A Study of the Safety, Tolerability and Effectiveness of EZM0414 (IPN60210) Investigative Product in Participants With Relapsed/Refractory Multiple Myeloma and Relapsed/Refractory Diffuse Large B Cell Lymphoma

Last updated: June 19, 2025
Sponsor: Epizyme, Inc.
Overall Status: Terminated

Phase

1

Condition

Lymphoma, B-cell

Lymphoma

Bone Neoplasm

Treatment

EZM0414

Clinical Study ID

NCT05121103
SET-101
  • Ages > 18
  • All Genders

Study Summary

This study will include participants with relapsed/refractory (R/R) Multiple Myeloma (MM). MM is a type of cancer of the blood. This study will also include participants with relapsed/refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL).

DLBCL is also a type of cancer of the blood. They are referred to as 'relapsed' when the disease has come back after treatment and 'refractory' when treatment no longer works. The study has 2 main parts, called phase 1 and phase 1b. The main objective of both parts will be to evaluate the safety and tolerability of the study drug, called EZM0414.

The main objective of phase 1b will also be to determine the effectiveness of EZM0414. During phase 1 six dose levels will be tested to obtain the most tolerated dose. Participants will receive study drug at the assigned dose level every 28 days. During phase 1b participants will receive study drug at the maximum tolerated dose in 28-day cycles.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. 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.

  2. Subjects must be ≥18 years of age at the time of signing the ICF (Informed ConsentForm).

  3. Subjects must have an Eastern Cooperative Oncology Group (ECOG) status of 0 - 2.

  4. For MM, subjects must have measurable disease by IMWG (International Myeloma WorkingGroup) 2016 criteria

  5. For DLBCL, subjects must have measurable disease by Lugano criteria

  6. Females must not be breastfeeding or pregnant at screening

  7. Females of childbearing potential must not have had unprotected sexual intercoursewhile participating in this study

  8. 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:

  1. Subjects with plasma cell leukemia defined as a plasma cell count >2000/mm3.

  2. Subjects with Waldenstrom's macroglobulinemia or smoldering MM.

  3. Subjects who had prior treatment with SETD2 or NSD2 inhibitor.

  4. Subjects with active acute or chronic systemic infection requiring systemictreatment, including COVID-19.

  5. Has cardiovascular impairment

  6. Prolongation of corrected QT interval using Fridericia's formula (QTcF) to > 480msec or history of long QT syndrome.

  7. Known left ventricular ejection fraction (LVEF) < 50% by either echocardiogram (ECHO) or multigated acquisition (MUGA).

  8. Prior major surgery within 4 weeks of treatment start.

  9. Known hypersensitivity to components of the investigational product.

  10. Subjects who have received treatment with any unapproved drug product within 4 weeksprior to screening.

  11. Current participation in any other interventional clinical study except for followup.

  12. Subjects with a history of or active malignancy other than disease under study

  13. Underlying medical/social conditions that in PI opinion will place the subject insignificant risk and affect the interpretation of toxicity and adverse eventsassessments.

  14. 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

Total Participants: 13
Treatment Group(s): 1
Primary Treatment: EZM0414
Phase: 1
Study Start date:
May 31, 2022
Estimated Completion Date:
April 30, 2024

Study Description

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.

Connect with a study center

  • City of Hope

    Duarte, California 91010
    United States

    Site Not Available

  • Regional Cancer Care Associates LLC - Chevy Chase

    Chevy Chase, Maryland 20815
    United States

    Site Not Available

  • Dana-Farber Cancer Institute

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • University of Michigan

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • Karmanos Cancer Institute

    Detroit, Michigan 48201
    United States

    Site Not Available

  • Astera Cancer Care

    East Brunswick, New Jersey 08816
    United States

    Site Not Available

  • Regional Cancer Care Associates LLC - Freehold

    Freehold, New Jersey 07728
    United States

    Site Not Available

  • Icahn School of Medicine at Mount Sinai

    New York, New York 10029
    United States

    Site Not Available

  • Memorial Sloan-Kettering Cancer Center

    New York, New York 10065
    United States

    Site Not Available

  • Weill Cornell Medicine

    New York, New York 10021
    United States

    Site Not Available

  • Baylor University Medical Center (Texas Oncology)

    Dallas, Texas 75246
    United States

    Site Not Available

  • MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

  • NEXT Virginia

    Fairfax, Virginia 22031
    United States

    Site Not Available

  • Aurora St. Luke's Medical Center

    Milwaukee, Wisconsin 53215
    United States

    Site Not Available

  • Medical College of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

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