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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

Clinical Trial Details

This clinical trial is designed for men and women who have multiple myeloma (MM) or diffuse large B-cell lymphoma (DLBCL) that has recurred after previous treatment or has not responded to their last treatment.
   
The purpose of this study is to evaluate the safety and effectiveness of the study drug EZM0414 at various dosages.
   
EZM0414 is an experimental drug that has not yet been approved by the United States Food and Drug Administration (FDA) for this type of cancer.

EZM0414 targets and can stop certain cancer cell growth by stopping a protein called SETD2, a histone lysine methyltransferase, from working.

In this study participants will take EZM0414 once a day on an empty stomach (no food 2 hours prior and 1 hour after) at approximately the same time each day in doses determined by the study team.
   
The study also involves collection of samples, such as y blood, bone marrow (biopsy and aspirates), tissue, and urine.
   
Participation is expected to last around 3 years.

Key Eligibility: 
  1. Participants must be 18 years or older
  2. Participants with must have a confirmed diagnosis of multiple myeloma (MM) or diffuse large B-cell lymphoma (DLBCL)

Detailed eligibility reviewed when participant contacts the study team.

Study contact by location

Upper East Side - Manhattan

Contact(s)

Kathleen Pogonowski, RN
(646) 962-6500
kap9111@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

2202024471

ClinicalTrials.gov:

NCT05121103

Status

Open to Enrollment

Age Group

Adult

Sponsor