Chemistry:ONT-380
ONT-380 is a small molecule[1] HER2-selective tyrosine kinase inhibitor. It is an investigational drug for HER2-positive breast cancer.[2][3] Cascadian Therapeutics[4] has an exclusive license from Array BioPharma 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.[2][5][6][7]
- 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)[8]
- 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)[9]
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 has stage IV HER2+ breast cancer patient 'worrying about normal stuff again'. May 2015
- ↑ 2.0 2.1 ONT-380 Active Against CNS Mets in HER2-Positive Breast Cancer. Dec 2015
- ↑ "Emerging Therapeutic Options for HER2-Positive Breast Cancer". Journal of Clinical Oncology. ISSN 0732-183X. http://meetinglibrary.asco.org/content/159167-176.
- ↑ "Cascadian Therapeutics". http://www.cascadianrx.com/.
- ↑ Oncothyreon Inc. (ONTY) Announces Data For ONT-380 In HER2-Positive Breast Cancer Patients With And Without Brain Metastases At The San Antonio Breast Cancer Symposium. Dec 2015 has detailed results
- ↑ TN, Virginia F. Borges, Cristiano Ferrario, Nathalie Aucoin, Carla Isadora Falkson, Qamar J. Khan, Ian E. Krop, Stephen Welch, Philippe L. Bedard, Alison Katherine Conlin, Jorge Chaves, Luke N. Walker, Erika Paige Hamilton; University of Colorado Cancer Center, Aurora, CO; Segal Cancer Centre, Jewish General Hospital, Montreal, QC, Canada; Hôpital Cité de la Santé de Laval, Laval, QC, Canada; University of Alabama Comprehensive Cancer Center, Birmingham, AL; University of Kansas Medical Center, Kansas City, KS; Dana-Farber Cancer Institute, Boston, MA; London Regional Cancer Program, London, ON, Canada; Princess Margaret Cancer Centre Univ Health Network, Toronto, ON, Canada; Providence Cancer Center Oncology and Hematology Care Clinic, Portland, OR; Northwest Medical Specialties, Tacoma, WA; Oncothyreon, Seattle, WA; Sarah Cannon Research Institute/Tennessee Oncology, Brentwood,. "Efficacy results of a phase 1b study of ont-380, a CNS-penetrant TKI, in combination with T-DM1 in HER2+ metastatic breast cancer (MBC), including patients (pts) with brain metastases. | 2016 ASCO Annual Meeting Abstracts". http://abstracts.asco.org/176/AbstView_176_170543.html.
- ↑ "SABCS15: Promising phase 1 results lead to phase 2 for ONT-380 in HER2+ breast cancer - Colorado Cancer Blogs". http://www.coloradocancerblogs.org/ont-380-san-antonio/.
- ↑ "A Phase 1b Study of ONT-380 Combined With Capecitabine and/or Trastuzumab in Patients With HER2+ Metastatic Breast Cancer - Full Text View - ClinicalTrials.gov". https://clinicaltrials.gov/ct2/show/NCT02025192.
- ↑ "Efficacy results of a phase 1b study of ont-380, a CNS-penetrant TKI, in combination with T-DM1 in HER2+ metastatic breast cancer (MBC), including patients (pts) with brain metastases.". Journal of Clinical Oncology. ISSN 0732-183X. http://meetinglibrary.asco.org/content/170543-176.
 |
