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

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05121103
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Epizyme, Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Relapsed/Refractory Multiple Myeloma, Relapsed/Refractory Diffuse Large B-Cell Lymphoma
Additional Details

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.

Arms & Interventions

Arms

Experimental: Open-label EZM0414

Interventions

Drug: - EZM0414

Formulation: 25 mg and 200 mg immediate-release film-coated tablets

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Rcca Md Llc, Chevy Chase, Maryland

Status

Recruiting

Address

Rcca Md Llc

Chevy Chase, Maryland, 20815

Site Contact

Iuliana Shapira, MD

clinicaltrials@epizyme.com

+1 (855) 500-1011

Dana-Farber Cancer Institute, Boston, Massachusetts

Status

Not yet recruiting

Address

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215

Site Contact

Clifton Mo, MD

clinicaltrials@epizyme.com

+1 (855) 500-1011

Astera Cancer Care, East Brunswick, New Jersey

Status

Recruiting

Address

Astera Cancer Care

East Brunswick, New Jersey, 08816

Site Contact

M. Houssein Kazemi, MD

clinicaltrials@epizyme.com

+1 (855) 500-1011

Freehold, New Jersey

Status

Recruiting

Address

Regional Cancer Care Associates LLC - Freehold

Freehold, New Jersey, 07728

Site Contact

Iuliana Shapira, MD

clinicaltrials@epizyme.com

+1 (855) 500-1011

Weill Cornell Medicine, New York, New York

Status

Not yet recruiting

Address

Weill Cornell Medicine

New York, New York, 10021

Site Contact

Ruben Niesvizky, MD

clinicaltrials@epizyme.com

+1 (855) 500-1011

MD Anderson Cancer Center, Houston, Texas

Status

Recruiting

Address

MD Anderson Cancer Center

Houston, Texas, 77030

Site Contact

Dai Chihara, MD

clinicaltrials@epizyme.com

+1 (855) 500-1011

NEXT Virginia, Fairfax, Virginia

Status

Recruiting

Address

NEXT Virginia

Fairfax, Virginia, 22031

Site Contact

Mitul Gandhi, MD

clinicaltrials@epizyme.com

+1 (855) 500-1011