Adenoviral Vector Monotherapy or Combination With Chemotherapy in Subjects With Recurrent/Metastatic Breast Cancer.

Multicenter, open-label, randomized study evaluating the safety and efficacy of INXN-1001 (veledimex) and INXN-2001 (Ad-RTS-hIL-12) alone and in combination with palifosfamide. Part 1 is the safety run-in where a safety assessment will be made after 1 cycle of therapy. Part 2, eligible subjects will be randomly assigned to active treatment Arms A or C. Once the monotherapy (Arm A) is determined to be safe and tolerable, Part 1 combination therapy (Arm C) will begin. Subjects should receive six cycles of study treatment, in the absence of meeting withdrawal criteria.