The trial is scheduled to start in the first quarter of 2015. It is designed to evaluate the safety and tolerability of ADXS-HER2 in patients diagnosed with metastatic HER2 expressing solid tumors which include breast, gastric, esophageal, and osteosarcoma.
In May 2014, the company was granted orphan drug designation for ADXS-HER2 for the treatment of osteosarcoma.
Within 30 calendar days of the IND filing, the FDA will notify the company of any questions it has or protocol revisions it requests which may delay the start of the proposed trial.
Advaxis president and chief executive officer Daniel O’Connor said: "This clinical trial will provide us with information that allows us to more fully understand the potential of ADXS-HER2 in HER2 expressing cancers, such as breast, gastric, esophageal cancers, and osteosarcoma."
HER2 is expressed in a percentage of solid tumors including breast, bladder, pancreatic, gastric, ovarian cancers and osteosarcoma.