
A global, multi-centre phase I trial at 33 centres tested SHR-A1811 in HER2-expressing advanced solid tumours refractory to standard therapies. From 2020 to 2023, 307 patients received doses from 1.0 to 8.0 mg/kg every three weeks. One patient experienced dose-limiting toxicities. Common grade 3+ adverse events were decreased neutrophil (38.8%) and WBC counts (22.8%). SHR-A1811 achieved objective responses in 59.9% of all patients, showing acceptable tolerability and promising antitumor activity. Recommended phase II doses are 4.8 or 6.4 mg/kg.
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