CDX-1140 + CDX-301 + Liposomal Doxorubicin

CDX-1140 will be administered 1.5mg/kg as intravenous injection once per cycle.

CDX-301 will be administered 75µg/kg as subcutaneous injection daily x 5 doses per cycle for 2 cycles.

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.

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.

Live record on ClinicalTrials.gov →

• Unresectable Stage III or Stage IV HER2 negative breast cancer (either triple negative or hormone receptor positive)
• Triple negative breast cancer for this study is defined as estrogen receptor <10%, progesterone receptor <10% by immunohistochemistry, and HER2- negative by Herceptest (0 or 1+) or not amplified by in situ hybridization as per routine clinical testing.
• Hormone receptor positive breast cancer for this study is defined as either estrogen receptor ≥10% or progesterone receptor ≥10% by immunohistochemistry, and HER2- negative by Herceptest (0 or 1+) or not amplified by in situ hybridization as per routine clinical testing.
• Age 18 years or older
• Performance status ECOG 0-2
• Life expectancy ≥ 12 weeks

Inclusion criteria as written on the registry, trimmed. The full list, with exclusions, is on the live record.