Ignite Creation Date:
2024-05-06 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 2:18 PM
Study NCT ID:
NCT05121103
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-03
First Post:
2021-10-18
Brief Title:
A Study of the Safety Tolerability and Effectiveness of EZM0414 Investigative Product in Participants With RelapsedRefractory Multiple Myeloma and RelapsedRefractory Diffuse Large B Cell Lymphoma
Sponsor:
Epizyme Inc
Organization:
Ipsen
Study Overview
Official Title:
A Phase 11b Open-Label Multi-Center Two-Part Study of SETD2 Inhibitor EZM0414 in Subjects With RelapsedRefractory Multiple Myeloma and RelapsedRefractory Diffuse Large B-Cell Lymphoma
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will include participants with relapsedrefractory RR Multiple Myeloma MM MM is a type of cancer of the blood This study will also include participants with relapsedrefractory RR 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
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
Detailed 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 RR MM and RR 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 RR DLBCL and RR MM with or without select genetic translocation
Dose expansion will enroll subjects in 3 cohorts Cohort 1 for RR MM subjects with t414 Cohort 2 for RR MM subjects without t414 and Cohort 3 for subjects with RR 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 RR DLBCL and RR MM with or without select genetic translocation
Dose expansion will enroll subjects in 3 cohorts Cohort 1 for RR MM subjects with t414 Cohort 2 for RR MM subjects without t414 and Cohort 3 for subjects with RR DLBCL
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None