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This first-in-human study established once-weekly 570 mg/m2 SAR125844 as the recommended dose for further studies in patients with advanced solid tumours. In the expansion phase, treatment at MTD was well tolerated, with ALT increase, anemia, and dyspnea the most commonly reported grade 3–4 TEAEs. The safety profile in the MET-amplified NSCLC cohort was comparable to the overall population.Preliminary antitumour activity was observed.
YS110 is well tolerated up to 6?mg?kg -1 Q1W, which has been defined as the RP2D, with encouraging prolonged disease stabilisations observed in a number of patients with advanced/refractory mesothelioma. Thirty-three patients (22 mesothelioma) received a median of 3 (range 1–30) YS110 infusions across six dose levels (0.1–6?mg?kg -1 ). MTD was not reached and two dose-limiting toxicities (infusion hypersensitivity reactions) led to the institution of a systemic premedication.
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