ArticleCancer communications (London, England)2021
Safety, tolerability, and pharmacokinetics of BAT8001 in patients with HER2-positive breast cancer: An open-label, dose-escalation, phase I study.
Article in Cancer communications (London, England), 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 1 of them a synthesis that pooled it.
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Who cites it
17 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Efficacy and safety of trastuzumab deruxtecan in gastrointestinal malignancies: a systemic review and meta-analysis.Frontiers in gastroenterology (Lausanne, Switzerland) · 2025Pooled it
- Dual-responsive semiconducting oligomer/doxorubicin nanoplatform for photoacoustic imaging-guided synergistic chemo-photothermal therapy.Journal of nanobiotechnology · 2026Article
- Navigating the future of gastric cancer treatment: a review on the impact of antibody-drug conjugates.Cell death discovery · 2025Review
- Antibody-drug conjugates in breast cancer: current evidence and future directions.Experimental hematology & oncology · 2025Review
- Emerging HER2 Targeting Immunotherapy for Cholangiocarcinoma.Oncology research · 2025Review
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- Clinical translation of antibody drug conjugate dosing in solid tumors from preclinical mouse data.Science advances · 2024Review
- Efficacy of the induced pluripotent stem cell derived and engineered CD276-targeted CAR-NK cells against human esophageal squamous cell carcinoma.Frontiers in immunology · 2024Article
- Clinical perspective: Antibody-drug conjugates for the treatment of HER2-positive breast cancer.Molecular therapy : the journal of the American Society of Gene Therapy · 2023Review
- Systematic Review on the Use of Biosimilars of Trastuzumab in HER2+ Breast Cancer.Biomedicines · 2022Review
- Novel development strategies and challenges for anti-Her2 antibody-drug conjugates.Antibody therapeutics · 2022Review
- Advances in Antibody-Drug Conjugates in the Treatment of HER2-Positive Breast Cancer.Breast cancer (Dove Medical Press) · 2022Review
- Review
- Safety, tolerability, and pharmacokinetics of BAT8001 in patients with HER2-positive breast cancer: An open-label, dose-escalation, phase I study.Cancer communications (London, England) · 2021Article
- Review
- Article
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19 authors.
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Abstract
backgroundThe introductions of anti- human epidermal growth factor receptor-2 (HER2) agents have significantly improved the treatment outcome of patients with HER2-positive breast cancer. BAT8001 is a novel antibody-drug conjugate targeting human epidermal growth factor receptor-2 (HER2)-expressing cells composed of a trastuzumab biosimilar linked to the drug-linker Batansine. This dose-escalation, phase I study was designed to assess the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of BAT8001 in patients with HER2-positive locally advanced or metastatic breast cancer.
methodsThis trial was conducted in subjects with histologically confirmed HER2-positive breast cancer (having evaluable lesions and an Eastern Cooperative Oncology Group performance status of 0 or 1) using a 3 + 3 design of escalating BAT8001 doses. Patients received BAT8001 intravenously in a 21-day cycle, with dose escalation in 5 cohorts: 1.2, 2.4, 3.6, 4.8, and 6.0 mg/kg. The primary objective was to evaluate the safety and tolerability of BAT8001. Preliminary activity of BAT8001 was also assessed as a secondary objective.
resultsBetween March 2017 to May 2018, 29 HER2-positive breast cancer patients were enrolled. The observed dose-limiting toxicities were grade 4 thrombocytopenia and grade 3 elevated transaminase. The maximum tolerated dose was determined to be 3.6 mg/kg. Grade 3 or greater adverse events (AEs) occurred in 14 (48.3%) of 29 patients, including thrombocytopenia in 12 (41.4%) patients, aspartate aminotransferase increased in 4 (13.8%) patients, γ-glutamyl transferase increased in 2 (6.9%) patients, alanine aminotransferase increased in 2 (6.9%) patients, diarrhea in 2 (6.9%) patients. Objective response was observed in 12 (41.4%; 95% confidence interval [CI] = 23.5%-61.1%) and disease control (including patients achieving objective response and stable disease) was observed in 24 (82.8%; 95% CI = 64.2%-94.2%) patients.
conclusionsBAT8001 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.
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