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Association details:
| Biomarker: | HER-2 expression |
|---|---|
| Cancer: | HER2 Positive Breast Cancer |
| Drug: | trastuzumab botidotin (A166) (HER2-targeted antibody-drug conjugate, Tubulin inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Study of A166 in Patients With Relapsed/Refractory Cancers Expressing HER2 Antigen or Having Amplified HER2 Gene
Excerpt:
...Evaluable or measurable HER2 positive (by ISH or NGS) disease or HER2 expressing disease....
Trial ID:
Source:
Title:
A Study of A166 in Patients With Advanced Solid Malignant Tumors
Excerpt:
...Determined HER2-positive disease (detected by ISH or NGS) or HER2-expressing disease by evaluation or detection....
Trial ID:
Less C2 evidence
Source:
Title:
Phase I study of A166 in patients with HER2-expressing locally advanced or metastatic solid tumors.
Published date:
05/19/2021
Excerpt:
57 pts (median age 53 [range 26-74], 50 female, 7 male) enrolled from Aug 1, 2018 to Nov 30, 2020. HER2 expression was available for all 57 pts...A166 had a manageable safety profile...demonstrated promising antitumor activity with clinically meaningful responses in heavily pretreated subjects with HER2-positive breast cancer.
DOI:
10.1200/JCO.2021.39.15_suppl.1024
Source:
Title:
A phase I study of safety and pharmacokinetics of A166, a novel selective inhibitor of human epidermal growth factor receptor-2 in Chinese patients with advanced solid tumors.
Published date:
05/28/2020
Excerpt:
Patients with HER2-expressing or amplified advanced solid tumors refractory to standard therapies were recruited....As of October 1, 2019 among 19 patients (breast cancer, colorectal cancer and gastric cancer)treated,no one experienced dose-limiting toxicity….A166 showed an acceptable safety profile and promising anti-tumor activity in patients with HER2-expressing advanced solid tumors.
DOI:
10.1200/JCO.2020.38.15_suppl.e13007
