Ignite Creation Date:
2024-05-06 @ 1:36 PM
Last Modification Date:
2024-10-26 @ 1:16 PM
Study NCT ID:
NCT04067336
Status:
RECRUITING
Last Update Posted:
2024-03-15
First Post:
2019-06-25
Brief Title:
First in Human Study of Ziftomenib in Relapsed or Refractory Acute Myeloid Leukemia
Sponsor:
Kura Oncology Inc
Organization:
Kura Oncology Inc
Study Overview
Official Title:
A Phase 12 First in Human Study of the Menin-MLLKMT2A Inhibitor KO-539 in Patients With Relapsed or Refractory Acute Myeloid Leukemia
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
True
If Expanded Access, NCT#:
NCT05738538
Has Expanded Access, NCT# Status:
AVAILABLE
Acronym:
None
Brief Summary:
This first-in-human FIH dose-escalation and dose-validationexpansion study will assess ziftomenib a menin-MLLKMT2A inhibitor in patients with relapsed or refractory acute myeloid leukemia AML as part of Phase 1 In Phase 2 assessment of ziftomenib will continue in patients with NPM1-m AML
Detailed Description:
This Phase 12 first-in-human FIH open-label dose-escalation and dose-validationexpansion study will assess ziftomenib a menin-MLLKMT2A inhibitor in patients with relapsed or refractory acute myeloid leukemia AML
The dose-escalation part of the study Phase 1a will determine the maximal tolerated dose MTD andor the recommended Phase 2 dose RP2D
The dose-validationexpansion part of the study Phase 1b will determine the safety tolerability and minimal biologically effective dose of ziftomenib in dosing cohorts which have demonstrated early biological activity and have been determined to be safe in the dose-escalation phase
The Phase 2 portion of the study will determine the safety tolerability and anti-leukemia activity of ziftomenib in patients with NPM1-m AML
The dose-escalation part of the study Phase 1a will determine the maximal tolerated dose MTD andor the recommended Phase 2 dose RP2D
The dose-validationexpansion part of the study Phase 1b will determine the safety tolerability and minimal biologically effective dose of ziftomenib in dosing cohorts which have demonstrated early biological activity and have been determined to be safe in the dose-escalation phase
The Phase 2 portion of the study will determine the safety tolerability and anti-leukemia activity of ziftomenib in patients with NPM1-m AML
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