Ignite Creation Date:
2024-05-06 @ 7:38 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06084481
Status:
RECRUITING
Last Update Posted:
2024-07-05
First Post:
2023-10-10
Brief Title:
Study to Assess Adverse Events and Change in Disease Activity in Adult Participants With Select Advanced Solid Tumor Indications Receiving Intravenous IV ABBV-400
Sponsor:
AbbVie
Organization:
AbbVie
Study Overview
Official Title:
A Phase 1 Open-Label Study to Evaluate the Efficacy and Safety of ABBV-400 in Select Advanced Solid Tumor Indications
Status:
RECRUITING
Status Verified Date:
2024-08
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:
Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably The purpose of this study is to assess adverse events and change in disease activity when ABBV-400 is given to adult participants to treat advanced solid tumors
ABBV-400 is an investigational drug being developed for the treatment of advanced solid tumors Study doctors put the participants in groups called cohorts Each cohort receives ABBV-400 alone monotherapy followed by a safety follow-up period Approximately 220 adult participants with hepatocellular carcinoma HCC pancreatic ductal adenocarcinoma PDAC biliary tract cancers BTC esophageal squamous cell carcinoma ESCC triple negative breast cancer TNBC hormone receptorhuman epidermal growth factor receptor 2 negative HER2- breast cancer hormone receptor-positive HRHER2-breast cancer BC head and neck squamous-cell-carcinoma HNSCC or advanced solid tumors will be enrolled in the study in approximately 60 sites worldwide
In the each cohorts participants with the following advanced solid tumor indications HCC PDAC BTC ESCC TNBC HRHER2-BC and HNSCC will receive intravenous IV ABBV-400 monotherapy for up to 2 years during and up to the treatment period with an additional safety follow-up period of up to 2 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 an approved institution hospital or clinic The effect of the treatment will be frequently checked by medical assessments blood tests questionnaires and side effects
ABBV-400 is an investigational drug being developed for the treatment of advanced solid tumors Study doctors put the participants in groups called cohorts Each cohort receives ABBV-400 alone monotherapy followed by a safety follow-up period Approximately 220 adult participants with hepatocellular carcinoma HCC pancreatic ductal adenocarcinoma PDAC biliary tract cancers BTC esophageal squamous cell carcinoma ESCC triple negative breast cancer TNBC hormone receptorhuman epidermal growth factor receptor 2 negative HER2- breast cancer hormone receptor-positive HRHER2-breast cancer BC head and neck squamous-cell-carcinoma HNSCC or advanced solid tumors will be enrolled in the study in approximately 60 sites worldwide
In the each cohorts participants with the following advanced solid tumor indications HCC PDAC BTC ESCC TNBC HRHER2-BC and HNSCC will receive intravenous IV ABBV-400 monotherapy for up to 2 years during and up to the treatment period with an additional safety follow-up period of up to 2 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 an approved institution hospital or clinic The effect of the treatment will be frequently checked by medical assessments blood tests questionnaires and 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?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-506227-29-00 | OTHER | EU CT | None |