Ignite Creation Date:
2024-05-06 @ 4:34 PM
Last Modification Date:
2024-10-26 @ 2:12 PM
Study NCT ID:
NCT05029999
Status:
RECRUITING
Last Update Posted:
2024-06-14
First Post:
2021-08-25
Brief Title:
CD40 Agonist Flt3 Ligand and Chemotherapy in HER2 Negative Breast Cancer
Sponsor:
University of Texas Southwestern Medical Center
Organization:
University of Texas Southwestern Medical Center
Study Overview
Official Title:
Phase 1 Pilot Study With Dose Expansion of Chemotherapy in Combination With CD40 Agonist and Flt3 Ligand in Metastatic HER2 Negative Breast Cancer
Status:
RECRUITING
Status Verified Date:
2024-06
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 study is being done to find out if the immunotherapy drugs called CDX-301 and CDX-1140 in combination with the standard chemotherapy treatment pegylated liposomal doxorubicin PLD Doxil are safe and effective at controlling the cancer in patients with metastatic triple Human Epidermal Growth Factor Receptor 2 HER2 negative breast cancer and to determine a safe dose and treatment schedule of the three drugs This research study will also test how your immune system responds to these treatments alone and in combination
Detailed Description:
The immunotherapy drugs CDX-301 and CDX-1140 in combination with the standard chemotherapy treatment PLD work by kickstarting the immune response against cancer cells CDX-301 increases the antigen presenting immune cells needed to kickstart the immune response CDX-1140 activates these cells and chemotherapy helps release antigens from the cancer cells to train these antigen presenting immune cells to recognize the cancer for the immune system to attack it
Metastatic or unresectable triple negative breast cancer patients will receive this triplet combination that has been shown in preclinical studies to be more effective than the individual treatments or doublet combinations To understand how the immunotherapies are working some patients will receive the immunotherapy or chemotherapy only for one cycle prior to receiving the full triplet combination therapy Ultimately all patients will receive the triplet combination to study safety and how effective this treatment is at controlling triple negative breast cancer and improving survival outcomes
The original design of the project includes 3 cohorts arms In February 2024 Cohort B experimental arm was closed to further enrollment
Cohort B includes the following design
PLD chemotherapy will be administered 40 mgm2 as intravenous injection once per cycle starting on cycle 2 until toxicity or progression
CDX-1140 will be administered 15mgkg as intravenous injection once per cycle until toxicity or progression for up to 24 months
CDX-301 will be administered 75µgkg as subcutaneous injection daily x 5 days cycles 1 and 2 only
Metastatic or unresectable triple negative breast cancer patients will receive this triplet combination that has been shown in preclinical studies to be more effective than the individual treatments or doublet combinations To understand how the immunotherapies are working some patients will receive the immunotherapy or chemotherapy only for one cycle prior to receiving the full triplet combination therapy Ultimately all patients will receive the triplet combination to study safety and how effective this treatment is at controlling triple negative breast cancer and improving survival outcomes
The original design of the project includes 3 cohorts arms In February 2024 Cohort B experimental arm was closed to further enrollment
Cohort B includes the following design
PLD chemotherapy will be administered 40 mgm2 as intravenous injection once per cycle starting on cycle 2 until toxicity or progression
CDX-1140 will be administered 15mgkg as intravenous injection once per cycle until toxicity or progression for up to 24 months
CDX-301 will be administered 75µgkg as subcutaneous injection daily x 5 days cycles 1 and 2 only
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