Hengrui HER2 ADC launches an international multi-center Phase I clinical trial.

The study, which will be conducted in 12 clinical centres around the world, plans to recruit 150 patients in the country and 226 internationally.
the main purpose of this study was to assess the safety and toerability of SHR-A1811 in patients with advanced solid tumors expressed or mutated in HER2, and to determine the recommended dose (RP2D) for phase II clinical studies of SHR-A1811.
secondary objectives were to assess the pharmacogenic dynamics (PK) characteristics of SHR-A1811 in patients with advanced solid tumors expressed or mutated in HER2; to assess the immunogenicity of SHR-A1811 in patients with advanced solid tumors expressed or mutated in HER2; and to initially assess the effectiveness of SHR-A1811 in treating advanced solid tumors expressed or mutated by HER2.
Hengrui previously announced that injection SHR-A1811 can be used to treat HER2 expression or mutation of tumor cells and internal swallowing, in the tumor cell lysase through protease shear release of toxins, induce cell cycle blocking to induce tumor apoptosis, intended to be used to treat HER2 expression or mutation of advanced solid tumors.
, similar products already on the market abroad are Kadcyla (T-DM1) and Enhertu (DS-8201a).
kadcyla was developed by Roche and will be imported into the market in 2019.
Enhertu was developed by AstraZeneta and First Third.
and abroad, ARX788, DP303c, A166, RC48, SYD985, BAT8001 and other products are in clinical trial stage.
2019, Kadcyla and Enhertu's total sales were about $1,431 million.
original title: Hengrui HER2 ADC launched an international multi-center Phase I clinical trial with a plan to recruit 376 patients with solid tumors.