Ignite Creation Date:
2024-05-06 @ 12:15 PM
Last Modification Date:
2024-10-26 @ 12:56 PM
Study NCT ID:
NCT03719430
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-08
First Post:
2018-10-22
Brief Title:
APX005M and Doxorubicin in Advanced Sarcoma
Sponsor:
Alexander Z Wei MD
Organization:
Columbia University
Study Overview
Official Title:
A Phase II Trial Evaluating APX005M a CD40 Agonistic Monoclonal Antibody in Combination With Standard-of-Care Doxorubicin for the Treatment of Advanced Sarcomas
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-03
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:
This phase II clinical trial will evaluate the safety and efficacy of adding APX005M a CD40 agonistic monoclonal antibody to doxorubicin for the treatment of patients with advanced soft tissue sarcoma The investigators believe that doxorubicin which is currently the standard of care for most advanced sarcomas could work better when combined with APX005M which is a type of immunotherapy
Detailed Description:
Doxorubicin a chemotherapy is currently considered standard-of-care treatment for most advanced soft tissue sarcomas This study will assess the safety and efficacy of combining APX005M a novel immunomodulatory drug together with standard of care doxorubicin for the treatment of patients with advanced soft tissue sarcoma APX005M is an agonistic monoclonal antibody targeting the CD40 receptor and may have favorable effects on certain types of immune cells in sarcoma tumors particularly macrophages
The primary objective is to determine the objective response rate Secondary objectives include further evaluation of safety and efficacy A subset of patients will undergo tumor biopsies at baseline and while on study treatment to help understand how the drug combination works and to evaluate how the composition of immune cells in the tumor changes after the treatment
The primary objective is to determine the objective response rate Secondary objectives include further evaluation of safety and efficacy A subset of patients will undergo tumor biopsies at baseline and while on study treatment to help understand how the drug combination works and to evaluate how the composition of immune cells in the tumor changes after the treatment
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?:
None
Is an FDA AA801 Violation?:
None