Ignite Creation Date:
2024-05-06 @ 3:57 PM
Last Modification Date:
2024-10-26 @ 2:00 PM
Study NCT ID:
NCT04811560
Status:
RECRUITING
Last Update Posted:
2024-05-23
First Post:
2021-03-22
Brief Title:
A Phase 12 Study of Bleximenib in Participants With Acute Leukemia
Sponsor:
Janssen Research Development LLC
Organization:
Janssen Research Development LLC
Study Overview
Official Title:
A Phase 12 First-in-Human Study of the Menin-KMT2A MLL1 Inhibitor Bleximenib in Participants With Acute Leukemia
Status:
RECRUITING
Status Verified Date:
2024-10
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:
The purpose of this study is to determine the recommended Phase 2 doses RP2Ds of bleximenib in phase 1 Part 1 Dose Escalation and to determine the safety and tolerability at RP2D in Phase 1 Part 2 Dose expansion The purpose of the Phase 2 part of the study is to evaluate the efficacy of bleximenib at the RP2D
Detailed Description:
Acute myeloid leukemia AML is a heterogeneous disease characterized by uncontrolled clonal expansion of hematopoietic progenitor cells myeloid blasts in the peripheral blood bone marrow and other tissues Acute lymphoblastic leukemia ALL is a hematologic malignancy propagated by impaired differentiation proliferation and accumulation of lymphoid progenitor cells in the bone marrow andor extramedullary sites JNJ-75276617 is an orally bioavailable potent and selective protein-protein interaction inhibitor of the binding between histone-lysine N-methyltransferase 2A KMT2A also called mixed-lineage leukemia 1 MLL1 wild-type and fusion and menin with activity in leukemic cell lines and primary leukemia patient or patient-derived samples with either KMT2A alterations including gene rearrangements KMT2A-r duplications and amplification or nucleophosmin 1 gene NPM1 alterations The primary goal of this FIH study is to establish the recommended Phase 2 dose RP2D of JNJ-75276617 with an acceptable safety profile The total duration of the study is up to 4 years and 9 months Safety assessment will include adverse events AEs serious adverse events SAEs physical examination Eastern Cooperative Oncology Group ECOG performance status vital signs electrocardiogram clinical safety laboratory assessment and pregnancy testing
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-005967-30 | EUDRACT_NUMBER | None | None |
| 75276617ALE1001 | OTHER | None | None |
| 2023-506581-31-00 | REGISTRY | EUCT number | None |