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

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ClinicalTrials.gov Identifier: NCT05121103
Recruitment Status : Recruiting
First Posted : November 16, 2021
Last Update Posted : January 13, 2023
Sponsor:
Information provided by (Responsible Party):
Epizyme, Inc.

Study Description
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Brief 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).

Condition or disease Intervention/treatment Phase
Relapsed/Refractory Multiple Myeloma Relapsed/Refractory Diffuse Large B-Cell Lymphoma Drug: EZM0414 Phase 1

Detailed Description:
The first part of the study will be a Phase 1 dose-escalation designed to evaluate the safety, tolerability, and 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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/1b, Open-Label, Multi-Center, Two-Part Study of SETD2 Inhibitor EZM0414 in Subjects With Relapsed/Refractory Multiple Myeloma and Relapsed/Refractory Diffuse Large B-Cell Lymphoma
Actual Study Start Date : November 11, 2021
Estimated Primary Completion Date : December 30, 2024
Estimated Study Completion Date : June 27, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Open-label EZM0414 Drug: EZM0414
Formulation: 25 mg and 200 mg immediate-release film-coated tablets


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants with treatment-emergent adverse events as assessed by CTCAE v5.0 [ Time Frame: Through study completion, an average of 3 years ]
    Severity of adverse events experienced by all subjects with at least 1 dose or partial dose of EZM0414 and DLT (Dose Limiting Toxicity) will be evaluated by the Investigator based on the CTCAE, version 5.0

  2. Establishing Maximum Tolerated Dose (MTD) and a recommended Phase 2 Dose (RP2D) [ Time Frame: Through study completion, an average of 3 years ]
    Determine MTD and select a dose for further evaluation in phase 2 (RP2D)

  3. Efficacy of EZM0414 as demonstrated by the effect on objective response rate (ORR) in subjects with R/R MM and R/R DLBCL [ Time Frame: Through study completion, an average of 3 years ]
    ORR defined as the proportion of responders as assessed by Investigator per IMWG 2016 guidelines for MM or Lugano 2014 guidelines for DLBCL


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. Subjects must be ≥18 years of age at the time of signing the ICF (Informed Consent Form).
  3. Subjects must have an Eastern Cooperative Oncology Group status of 0 - 2.
  4. For MM, subjects must have measurable disease by IMWG (International Myeloma Working Group) 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 intercourse while participating in this study
  8. 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

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 systemic treatment, including COVID-19.
  5. Has cardiovascular impairment
  6. Prolongation of corrected QT interval using Fridericia's formula (QTcF) to > 480 msec 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 weeks prior to screening.
  11. Current participation in any other interventional clinical study except for follow up.
  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 in significant risk and affect the interpretation of toxicity and adverse events assessments.
  14. 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05121103


Contacts
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Contact: Medical Affairs +1 (855) 500-1011 clinicaltrials@epizyme.com

Locations
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United States, Maryland
Regional Cancer Care Associates LLC - Chevy Chase Recruiting
Chevy Chase, Maryland, United States, 20815
Contact: Iuliana Shapira, MD         
United States, Massachusetts
Dana-Farber Cancer Institute Not yet recruiting
Boston, Massachusetts, United States, 02215
Contact: Clifton Mo, MD         
United States, Michigan
Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201
Contact: Dipenkumar Modi, MD         
United States, New Jersey
Astera Cancer Care Recruiting
East Brunswick, New Jersey, United States, 08816
Contact: M. Houssein Kazemi, MD         
Regional Cancer Care Associates LLC - Freehold Recruiting
Freehold, New Jersey, United States, 07728
Contact: Iuliana Shapira, MD         
United States, New York
Weill Cornell Medicine Recruiting
New York, New York, United States, 10021
Contact: Ruben Niesvizky, MD         
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Contact: Joshua Richter, MD         
United States, Texas
Baylor University Medical Center (Texas Oncology) Recruiting
Dallas, Texas, United States, 75246
Contact: Moshe Y Levy, MD         
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Dai Chihara, MD         
United States, Virginia
NEXT Virginia Recruiting
Fairfax, Virginia, United States, 22031
Contact: Mitul Gandhi, MD         
United States, Wisconsin
Aurora St. Luke's Medical Center Recruiting
Milwaukee, Wisconsin, United States, 53215
Contact: Stephen Medlin, DO         
Sponsors and Collaborators
Epizyme, Inc.
More Information
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Responsible Party: Epizyme, Inc.
ClinicalTrials.gov Identifier: NCT05121103    
Other Study ID Numbers: SET-101
First Posted: November 16, 2021    Key Record Dates
Last Update Posted: January 13, 2023
Last Verified: January 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lymphoma
Multiple Myeloma
Neoplasms, Plasma Cell
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
 Immune System Diseases
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoma, Non-Hodgkin