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A Phase 2 Study to Evaluate the Efficacy and Safety of an Adjuvant Therapeutic Cancer Vaccine (AST-301, pNGVL3-hICD) in Patients With HER2 Low Breast Cancer (Cornerstone-001)

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Trial Profile

A Phase 2 Study to Evaluate the Efficacy and Safety of an Adjuvant Therapeutic Cancer Vaccine (AST-301, pNGVL3-hICD) in Patients With HER2 Low Breast Cancer (Cornerstone-001)

Status: Discontinued
Phase of Trial: Phase II

Latest Information Update: 19 Jun 2024

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At a glance

  • Drugs AST-301 (Primary) ; Capecitabine (Primary) ; Pembrolizumab (Primary) ; Sargramostim (Primary)
  • Indications Advanced breast cancer; Early breast cancer; HER2 negative breast cancer; Male breast cancer; Triple negative breast cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms Cornerstone001
  • Sponsors Aston Science

Most Recent Events

  • 13 Jun 2024 Status changed from recruiting to discontinued due to difficulty in recruiting patients
  • 01 Sep 2022 According to an Aston Science media release, Mary L. (Nora) Disis, M.D., University of Washington is the principle investigator of the study.
  • 01 Sep 2022 According to an Aston Science media release, the company plans for a BLA submission based on this study as it adopts the same patient group and design as in Phase 3 clinical trials. Depending on the interim results, discussions of expedited authorization of BLA and pivotal cohort expansion to generate corroborative clinical data in Phase 2 clinical trial are expected.

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