Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06297941
Status:
RECRUITING
Last Update Posted:
2024-05-02
First Post:
2024-02-23
Brief Title:
Study of REM-422 in Patients With AML or Higher Risk MDS
Sponsor:
Remix Therapeutics
Organization:
Remix Therapeutics
Study Overview
Official Title:
A Phase 1 Multicenter Open-Label Study of REM-422 an MYB mRNA Degrader in Patients With RelapsedRefractory AML or Higher-Risk MDS
Status:
RECRUITING
Status Verified Date:
2024-07
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 goal of this study is to determine the safety and antitumor effects of REM-422 a MYB mRNA degrader in people with Higher Risk MDS and relapsedrefractory AML
Detailed Description:
This is a Phase 1 open-label non-randomized multicenter study investigating REM-422 a potent selective and oral small molecule mRNA degrader that reduces expression of the MYB transcription factor for patients with higher risk MDS or relapsedrefractory AML
This study includes a Dose Escalation Phase and a Dose Expansion Phase The purpose of the Dose Escalation Phase is to determine the maximum tolerated dose MTD andor recommended Phase 2 dose RP2D of REM-422 in patients with higher risk MDS or relapsedrefractory AML The purpose of Dose Expansion is to further evaluate the safety and anti-tumor activity of the RP2D carried forward from Dose Escalation
Participation in this study will continue until disease progression therapy intolerance or participant withdrawal
This study includes a Dose Escalation Phase and a Dose Expansion Phase The purpose of the Dose Escalation Phase is to determine the maximum tolerated dose MTD andor recommended Phase 2 dose RP2D of REM-422 in patients with higher risk MDS or relapsedrefractory AML The purpose of Dose Expansion is to further evaluate the safety and anti-tumor activity of the RP2D carried forward from Dose Escalation
Participation in this study will continue until disease progression therapy intolerance or participant withdrawal
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