Her2-BATS and Pembrolizumab in Metastatic Breast Cancer
Status:
Recruiting
Trial end date:
2028-11-30
Target enrollment:
Participant gender:
Summary
This proposal uses HER2Bi armed activated T-cells (HER2 BATs) to target breast cancer in
combination with pembrolizumab (PBZ) in women with metastatic breast cancer (MBC). Phase I
will determine a safe dose of the combination of PBZ and HER2 BATs in 3 to 18 patients. In
the phase II portion, an additional 12 patients will be treated at the selected dose to
further evaluate the safety and preliminary efficacy.
Study treatment includes a combination of 8 infusions of BATs using a previously established
schedule and one to three infusions of PBZ (200 mg per dose). PBZ will be added to 8
infusions of BATs in 3 schedules: #1) after the 8th BATs infusion; #2) after the 4th and 8th
BATs infusions; and then, #3) before the 1st and after the 4th and 8th BATs infusions.