Ignite Creation Date:
2024-05-06 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06158958
Status:
RECRUITING
Last Update Posted:
2024-06-18
First Post:
2023-11-29
Brief Title:
A Study to Assess the Safety Pharmacokinetics and Efficacy of Intravenous IV ABBV-303 as Monotherapy and in Combination With IV Infused Budigalimab ABBV-181 in Adults With Advanced Solid Tumors
Sponsor:
AbbVie
Organization:
AbbVie
Study Overview
Official Title:
A Phase 1 First-in-Human Open-Label Study Evaluating the Safety Pharmacokinetics and Efficacy of ABBV-303 as Monotherapy and in Combination With Budigalimab ABBV-181 in Adult Subjects With Advanced Solid Tumors
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:
Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably The purpose of this study is to assess safety tolerability pharmacokinetics and preliminary efficacy of ABBV-303 as a monotherapy and in combination with budigalimab ABBV-181
ABBV-303 is an investigational drug being developed for the treatment of solid tumors There are multiple treatment arms in this study Participants will either receive ABBV-303 as a single agent or in combination with budigalimab another investigational drug at different doses Approximately 181 adult participants will be enrolled in the study across sites worldwide
In Part A ABBV-303 will be intravenously IV infused in escalating doses as a monotherapy in participants with relapsed Rrefractory R solid tumors RR non-small cell lung cancer NSCLC RR renal cell carcinoma RCC RR head and neck squamous cell carcinoma HNSCC or RR tissue agnostic participants with mesenchymal epithelial transition In Part B ABBV-303 in combination with budigalimab will be IV infused in participants with RR solid tumors or NSCLC 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-303 is an investigational drug being developed for the treatment of solid tumors There are multiple treatment arms in this study Participants will either receive ABBV-303 as a single agent or in combination with budigalimab another investigational drug at different doses Approximately 181 adult participants will be enrolled in the study across sites worldwide
In Part A ABBV-303 will be intravenously IV infused in escalating doses as a monotherapy in participants with relapsed Rrefractory R solid tumors RR non-small cell lung cancer NSCLC RR renal cell carcinoma RCC RR head and neck squamous cell carcinoma HNSCC or RR tissue agnostic participants with mesenchymal epithelial transition In Part B ABBV-303 in combination with budigalimab will be IV infused in participants with RR solid tumors or NSCLC 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?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-504714-30 | OTHER | EU CT | None |