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Association details:
| Biomarker: | HER-2 positive |
|---|---|
| Cancer: | HER2 Positive Breast Cancer |
| Drug: | BAT8001 (Microtubule inhibitor, HER2-targeted antibody-drug conjugate) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
The Efficacy and Safety of BAT8001 Injection for the Treatment of HER2-positive Advanced Breast Cancer
Excerpt:
...HER2-positive (defined as: IHC 3+ or FISH+) confirmed by the central laboratory of this study....
Trial ID:
Source:
Title:
A clinical study for evaluating the efficacy and safety of BAT8001 injection for the treatment of HER2-positive advanced breast cancer
Excerpt:
...HER2-positive (defined as: IHC 3+ or FISH+) confirmed by the central laboratory of this study. ...
Trial ID:
More C2 evidence
Source:
Title:
An Open-Label, Dose Escalation Phase I Clinical Trial for Safety, Tolerability and Pharmacokinetics of BAT8001 for Injection in Patients with HER2-Positive Solid Tumors
Excerpt:
...Patients with breast cancer or gastric cancer (including gastroesophageal junction adenocarcinoma) histopathologically or cytologically diagnosed and tested HER2-positive (IHC 3+ and/or ISH+); 4. ...
Trial ID:
Less C2 evidence
Source:
Title:
Safety, tolerability, and pharmacokinetics of BAT8001 in patients with HER2-positive breast cancer: An open-label, dose-escalation, phase I study
Published date:
02/02/2021
Excerpt:
BAT8001 demonstrated favorable safety profiles, with promising anti-tumor activity in patients with HER2-positive locally advanced or metastatic breast cancer. BAT8001 has the potential to provide a new therapeutic option in patients with metastatic HER2-positive breast cancer.
DOI:
10.1002/cac2.12135
Source:
Title:
Abstract P6-17-39: BAT8001, a potent anti-HER2 antibody-drug conjugate with a novel stable linker for the treatment of HER2-positive breast cancer
Excerpt:
BAT8001 is internalized in HER2-positive cancer cells. It inhibits proliferation of HER2-positive tumor cells with IC50s of ˜0.1 nM, similar to the potency of T-DM1. BAT8001 also induces apoptosis in HER2-positive cancer cells. In both cell-line and patient-derived mouse xenograft (PDX) models, BAT8001 demonstrates strong inhibition activity on tumor growth. For example, in a cell-line model of breast cancer (BT474), BAT8001 demonstrates potent activity with complete responses in all animals tested at the 15mg/kg dose level....BAT8001 is very efficacious in cell-line xenograft models of breast cancer.
DOI:
https://doi.org/10.1158/1538-7445.SABCS18-P6-17-39
