Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Heart and Blood Diseases

Rare Diseases

Lymphoma

Multiple Myeloma

Neoplasms, Plasma Cell

Lymphoma, Large B-Cell, Diffuse

Lymphoma, B-Cell

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoma, Non-Hodgkin

Lymphosarcoma

B-cell Lymphoma

Diffuse Large B-Cell Lymphoma

Participants will receive EZM0414 in continuous 28-day cycles. EZM0414 will be administered orally once daily (QD) without food.

Participants who receive EZM0414 at Maximum tolerated dose (MTD) and do not have Dose limiting toxicities (DLT) in the dose escalation part of the study will be rolled over to a cohort of this dose expansion part.

Cohort 1 for R/R MM Participants. Cohort 2 for R/R MM Participants. Cohort 3 for Participants with R/R DLBCL.

Immediate-release film-coated tablets: Six dose levels starting at 100 mg, and then 200 mg, 300 mg, 400 mg, 600 mg, and 900 mg as well as an optional step-down dose level of 75 mg (if needed)

EZM0414

Ipsen Recruitment Enquiries

Clifton Mo, MD

Dipenkumar Modi, MD

M. Houssein Kazemi, MD

Iuliana Shapira, MD

Ruben Niesvizky, MD

Joshua Richter, MD

Moshe Y Levy, MD

Dai Chihara, MD

Mitul Gandhi, MD

Ipsen Medical Director

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.

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.

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

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

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

Percentage of participants with clinically significant changes in physical examination findings will be reported. The clinical significance will be evaluated by the Investigator based on the CTCAE, version 5.0.

Percentage of participants with clinically significant changes in vital signs will be reported. The clinical significance will be evaluated by the investigator based on the CTCAE, version 5.0.

Percentage of participants with clinically significant changes in ECG readings will be reported. The clinical significance will be will be evaluated by the investigator based on the CTCAE, version 5.0.

Percentage of participants with clinically significant change in laboratory parameters (blood chemistry, hematology and coagulation) will be reported. The clinical significance will be evaluated by the Investigator based on the CTCAE, version 5.0.

ECOG is a 6-point performance status scale used to assess performance using participant as a key indicator (e.g., 0 = fully active, 2 = up and about more than 50% of walking hours, 5 = dead) Performance status will be assessed per usual clinical practice and will be recorded in the medical record.

Defined as any medication or vaccine, including over-the-counter or prescription medicines, vitamins, and/or herbal supplements that the participant is receiving at the time of enrollment or received during the study.

Events will be assessed as DLTs according to the Common Terminology Criteria for Adverse Events (CTCAE 5.0)

Recommended Phase 2 will be established by analyzing AE, clinical laboratory tests and pharmacokinetics Profile.

Defined as the proportion of responders as assessed by Investigator per International Myeloma Working Group (IMWG) 2016 guidelines for MM (Stringent complete response (sCR), Complete Response (CR), Very good partial response (VGPR), and Partial Response (PR)) or Lugano 2014 guidelines for Diffuse large B cell lymphoma (DLBCL) (CR+PR).

Defined as the time from start of treatment until the first documented PD, as assessed by Investigator per IMWG 2016 guidelines for MM or Lugano 2014 guidelines for DLBCL or death due to any cause, whichever occurs first.

Defined as the proportion of subjects who have achieved confirmed CR, sCR, PR, VGPR, minimal response or stable disease (SD) per IMWG 2016 Guidelines for MM or CR, PR, or SD per Lugano 2014 Guidelines for DLBCL since administration of EZM0414 in dose expansion part (including the cycle 1 observations of the subjects who receive EZM0414 at MTD in the dose escalation part and are rolled over to the dose expansion part).

Defined as the time from initial CR or PR to documented progression or death, whichever comes first, as assessed by Investigator per IMWG 2016 guidelines for MM or Lugano 2014 guidelines for DLBCL

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study of the Safety, Tolerability and Effectiveness of EZM0414 Investigative Product in Participants With Relapsed/Refractory Multiple Myeloma and Relapsed/Refractory Diffuse Large B Cell Lymphoma	NCT05121103	Multiple Myelom... Diffuse Large B... Diffuse Large B... Multiple Myelom...	EZM0414	18 Years -	Ipsen
A Study of the Safety, Tolerability and Effectiveness of EZM0414 Investigative Product in Participants With Relapsed/Refractory Multiple Myeloma and Relapsed/Refractory Diffuse Large B Cell Lymphoma	NCT05121103	Multiple Myelom... Diffuse Large B... Diffuse Large B... Multiple Myelom...	EZM0414	18 Years -	Ipsen

Spots Global Cancer Trial Database for ezm0414

Every month we try and update this database with for ezm0414 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for ezm0414

Every month we try and update this database with for ezm0414 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for ezm0414 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.