Supriya Ghosh (Editor)

ONT 380

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ONT-380 is a small molecule HER2-selective tyrosine kinase inhibitor. It is an investigational drug for HER2-positive breast cancer. Cascadian Therapeutics has an exclusive license from Array BioPharma Inc. to manufacture, develop and commercialize ONT-380.

Clinical Trials

Two early stage clinical trials have reported encouraging results; both of these studies had options to enroll patients with central nervous system (CNS) metastases.

  • A Phase 1b, Open-label Study to Assess the Safety and Tolerability of ONT-380 Combined with Capecitabine and Trastuzumab, Alone and in Combination in HER2+ Metastatic Breast Cancer (NCT02025192)
  • A Phase 1b, Open-label Study to Assess the Safety and Tolerability of ONT-380 Combined With Ado-trastuzumab Emtansine (Trastuzumab Emtansine;T-DM1) (NCT01983501)
  • The HER2CLIMB study is currently open for enrollment. This clinical trial is a Phase 2 randomized, double-blinded, placebo-controlled study of ONT-380 in combination with Herceptin and Xeloda in patients with pretreated, unresectable locally advanced or metastatic HER2-positive breast cancer (NCT02614794).

    References

    ONT-380 Wikipedia