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Association details:
Evidence:
Evidence Level:
Sensitive: B - Late Trials
Title:

FDA Grants ARX788 Fast Track Designation for HER2-positive Metastatic Breast Cancer

Published date:
01/04/2021
Excerpt:
Ambrx announced that the U.S. Food and Drug Administration (FDA) granted ARX788 Fast Track Designation as monotherapy for the treatment of advanced or metastatic HER2-positive breast cancer patients who have received one or more prior anti-HER2 based regimens in the metastatic setting.
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

A clinical research study to test different doses of a study drug (ARX788), to see which dose is safest and its effectiveness(shrinks tumor size) in patients with advanced cancer. Estudio de investigación clínica para probar diferentes dosis del fármaco del estudio (ARX788), para ver qué dosis es la más segura y su efectividad (redución tamaño del tumor) en pacientes con cáncer avanzado.

Excerpt:
...Central laboratory-confirmed HER2-positive expression (estrogen receptor/progesterone receptor positive subjects may be enrolled if they are HER2-positive) according to 2018 American Society of Clinical Oncology – College of American Pathologists (ASCO-CAP) guidelines. ...
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

ARX788 in Breast Cancer With Low Expression of HER2

Excerpt:
...- Diagnosed as HR arbitrary/HER2 low expression unresectable and/or metastatic breast cancer....
Trial ID:
Less C2 evidence
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Ambrx Presents Phase 1 Trial Data Update and Phase 2/3 Clinical Trial in Progress for Lead Program ARX788 at the 2020 San Antonio Breast Cancer Symposium

Published date:
12/10/2020
Excerpt:
ARX788 Phase 1 studies demonstrated promising antitumor activity in heavily pre-treated cancer patients...ORR of 74% (14/19) and DCR of 100% in the 1.5 mg/kg cohort of the Phase 1 HER2-positive breast cancer trial in China...ORR of 67% (2/3) and DCR of 100% in the 1.5 mg/kg cohort of Phase 1 HER2-positive pan tumor trial in U.S. and Australia...
Evidence Level:
Sensitive: D – Preclinical
Title:

Nonclinical Development of Next Generation Site-Specific HER2 Targeting Antibody Drug Conjugate (ARX788) for Breast Cancer Treatment

Published date:
06/04/2020
Excerpt:
ARX788 exhibits significant, dose-dependent anti-tumor activity against HER2 expressing breast and gastric xenograft tumors.
DOI:
10.1158/1535-7163.MCT-19-0692