Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06618001
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-26
Brief Title:
A Study of JNJ-89853413 for Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Neoplasms
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 1 First-in-Human Dose Escalation Study of JNJ-89853413 for Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Neoplasms
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of Part 1 Dose Escalation of the study is to assess the safety and tolerability and to identify the recommended Phase 2 doses RP2Ds in participants with relapsed or refractory RR acute myeloid leukemia AML that is a type of blood cancer that has come back after treatmentor has stopped responding to treatment or RR higher-risk type of myelodysplastic neoplasms MDS type of blood cancer The purpose of Part 2 Cohort Expansion is to further assess the safety tolerability and efficacy in participants with RR AML or higher-risk types of MDS
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None