Oncothyreon, Array BioPharma Announce Initiation Of Phase 1b Trial Of ONT-380

(RTTNews) - Oncothyreon Inc. (ONTY) and Array BioPharma Inc. (ARRY) announced the initiation of a Phase 1b trial of ONT-380, ARRY-380, in combination with Xeloda (capecitabine) and/or Herceptin (trastuzumab) in patients with metastatic HER2+ breast cancer. ONT-380 is an orally active, reversible and selective small-molecule HER2 inhibitor invented by Array and being developed by Oncothyreon in collaboration with Array.

The trial is a dose-escalation study in patients who have been previously treated with Herceptin (trastuzumab) and Kadcyla (ado-trastuzumab emtansine or TDM-1) for metastatic breast cancer. The trial is expected to enroll approximately 50 patients.

The primary objective of the study is to determine the maximum-tolerated and/or recommended Phase 2 dose (MTD/RP2D) of ONT-380 in combination with the approved dose of either Xeloda or Herceptin or both. Secondary objectives include an evaluation of the safety and preliminary anti-tumor activity of the combinations.