Ignite Creation Date:
2024-05-06 @ 7:35 PM
Last Modification Date:
2024-10-26 @ 3:10 PM
Study NCT ID:
NCT06068868
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2023-09-29
Brief Title:
Study to Evaluate Adverse Events and Movement of Intravenously IV Infused ABBV-787 in Adult Participants With RelapsedRefractory RR Acute Myeloid Leukemia AML
Sponsor:
AbbVie
Organization:
AbbVie
Study Overview
Official Title:
A Phase 1 First-in-Human Study Evaluating Safety Pharmacokinetics and Efficacy of ABBV-787 in Adult Subjects With Acute Myeloid Leukemia AML
Status:
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:
Acute myeloid leukemia AML is the second most common type of leukemia diagnosed in adults and children but most cases occur in adults This study is to evaluate how safe ABBV-787 is and how it moves within the body in adult participants with relapsedrefractory RR acute myeloid leukemia AML Adverse events and maximum tolerated dose MTD of ABBV-787 will be assessed
ABBV-787 is an investigational drug being developed for the treatment of AML Participants will receive ABBV-787 in escalating doses until the maximum tolerated dose MTD is determined Approximately 60 adult participants with a diagnosis of AML will be enrolled worldwide
Participants will receive intravenous IV infusions of ABBV-787 during the approximately 3 year duration a participant is followed
There may be higher treatment burden for participants in this trial compared to their standard of care Participants will attend regular visits during the study at a hospital or clinic The effect of the treatment will be checked by medical assessments blood tests and checking for side effects
ABBV-787 is an investigational drug being developed for the treatment of AML Participants will receive ABBV-787 in escalating doses until the maximum tolerated dose MTD is determined Approximately 60 adult participants with a diagnosis of AML will be enrolled worldwide
Participants will receive intravenous IV infusions of ABBV-787 during the approximately 3 year duration a participant is followed
There may be higher treatment burden for participants in this trial compared to their standard of care Participants will attend regular visits during the study at a hospital or clinic The effect of the treatment will be checked by medical assessments blood tests and checking for side effects
Detailed Description:
None
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?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-505233-27-00 | OTHER | EU CT | None |