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trastuzumab botidotin
- Development stage
- Phase 3
- Lead developer
- Kelun-Biotech
- Modality
- Cytotoxic ADCs → Antibody-Drug Conjugates (ADCs) → Antibody Conjugates → Antibody-Based Therapeutics, Monoclonal Antibodies → Antibody-Based Therapeutics
- Administration
- Intravenous
01
Overview
Trastuzumab botidotin is an antibody-drug conjugate (ADC) designed for the treatment of HER2-positive and HER2-low expressing solid tumors, including metastatic breast cancer, non-small cell lung cancer, colorectal cancer, gastric cancer, and adenocarcinoma of the gastroesophageal junction. It consists of a recombinant humanized IgG1 anti-HER2 monoclonal antibody (trastuzumab) conjugated via a stable enzyme-cleavable linker to duostatin-5 (Duo-5), an MMAF derivative that acts as a highly cytotoxic tubulin inhibitor. Upon binding to HER2 on tumor cells and internalization, the ADC releases Duo-5 inside the cell, which binds to tubulin and inhibits its polymerization—resulting in G2/M phase cell cycle arrest and apoptosis. Trastuzumab botidotin also exhibits antibody-dependent cell-mediated cytotoxicity (ADCC) activity and can inhibit the HER2 signaling pathway. The drug is being developed by KLUS Pharma/Sichuan Kelun Pharmaceutical for multiple oncology indications[1][6][7].
- Brand names
- Shutailai舒泰莱
- Other names
- trastuzumab botidotin
02
Targets
TUBB (Tubulin (alpha and beta subunits))ERBB2 (Erb-b2 receptor tyrosine kinase 2)
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