Ignite Creation Date:
2024-07-17 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06488378
Status:
RECRUITING
Last Update Posted:
2024-07-05
First Post:
2024-06-28
Brief Title:
Phase Ib Study of Axatilimab in Combination with Olaparib in BRCA12 and PALB2- Associated Metastatic HER2-negative Breast Cancer
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
Phase Ib Study of Axatilimab in Combination with Olaparib in BRCA12 and PALB2- Associated Metastatic HER2-negative Breast Cancer
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:
This research is being done to evaluate the safety and tolerability of the new drug axatilimab in combination with olaparib a standard of care treatment in Breast Cancer 12 genes BRCA 12 and PALB2 associated HER2-negative metastatic breast cancer
The names of the study drugs involved in this study are
Axatilimab a type of antibody
Olaparib a type of PARP inhibitor
The names of the study drugs involved in this study are
Axatilimab a type of antibody
Olaparib a type of PARP inhibitor
Detailed Description:
This is a non-randomized open-label proof-of-concept phase 1 study to evaluate the safety and tolerability of a drug known as Axatilimab in combination with the drug Olaparib in BRCA12 and PALB2 associated HER2-negative breast cancer
The US Food and Drug Administration FDA has not approved axatilimab as a treatment for any disease
The FDA has approved olaparib as a treatment option for BRCA12 and PALB2 associated HER2-negative breast cancer and it is considered standard of care for those types of breast cancer The FDA has approved olaparib for metastatic breast cancer that has spread BRCA12 associated HER2-negative breast cancer
The research study procedures include screening for eligibility study treatment in-clinic visits tumor biopsies blood tests Computerized Tomography CT scans Magnetic Resonance Imaging MRI scans and electrocardiograms
Participation in this research study is expected to last for as long as there is clinical benefit and participants will be followed for a maximum of three years after finishing study treatment
It is expected that about 16-20 people will take part in this research study
Incyte Corporation is funding this research study and providing Axatilimab
The US Food and Drug Administration FDA has not approved axatilimab as a treatment for any disease
The FDA has approved olaparib as a treatment option for BRCA12 and PALB2 associated HER2-negative breast cancer and it is considered standard of care for those types of breast cancer The FDA has approved olaparib for metastatic breast cancer that has spread BRCA12 associated HER2-negative breast cancer
The research study procedures include screening for eligibility study treatment in-clinic visits tumor biopsies blood tests Computerized Tomography CT scans Magnetic Resonance Imaging MRI scans and electrocardiograms
Participation in this research study is expected to last for as long as there is clinical benefit and participants will be followed for a maximum of three years after finishing study treatment
It is expected that about 16-20 people will take part in this research study
Incyte Corporation is funding this research study and providing Axatilimab
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