Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06318273
Status:
RECRUITING
Last Update Posted:
2024-07-10
First Post:
2024-03-13
Brief Title:
A Study to Assess Adverse Events and How Intravenously IV Infused ABBV-969 Moves Through the Bodies of Adult Participants With Metastatic Castration-Resistant Prostate Cancer
Sponsor:
AbbVie
Organization:
AbbVie
Study Overview
Official Title:
A Phase 1 First-in-Human Study Evaluating Safety Pharmacokinetics and Efficacy of ABBV-969 in Adult Subjects With Metastatic Castration-Resistant Prostate Cancer
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:
Prostate cancer has the second highest incidence rate and is the fifth leading cause of cancer-related deaths among men worldwide The purpose of this study is to assess safety pharmacokinetics and efficacy of ABBV-969 as a monotherapy
ABBV-969 is an investigational drug being developed for the treatment of metastatic castration-resistant prostate cancer mCRPC There are parts to this study Participants will receive ABBV-969 as a single agent at different doses Approximately 120 adult participants will be enrolled in the study across sites worldwide
In part 1 dose escalation ABBV-969 will be intravenously infused in escalating doses as a monotherapy In part 2 multiple doses will be selected from Part 1 and mCRPC participants will be assigned to one of these doses in a randomized fashion to determine the recommended Phase 2 dose The estimated duration of the study is up to 3 years
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 and may require frequent medical assessments blood tests and scans
ABBV-969 is an investigational drug being developed for the treatment of metastatic castration-resistant prostate cancer mCRPC There are parts to this study Participants will receive ABBV-969 as a single agent at different doses Approximately 120 adult participants will be enrolled in the study across sites worldwide
In part 1 dose escalation ABBV-969 will be intravenously infused in escalating doses as a monotherapy In part 2 multiple doses will be selected from Part 1 and mCRPC participants will be assigned to one of these doses in a randomized fashion to determine the recommended Phase 2 dose The estimated duration of the study is up to 3 years
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 and may require frequent medical assessments blood tests and scans
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