Simcere Pharmaceutical Group Limited’s (HKG: 2096) subsidiary, Simcere Zaiming, has announced the initiation of a Phase III study for SIM0270 (SCR-6852), an oral brain-penetrating selective estrogen receptor down-regulator (SERD) inhibitor. The study includes the first patient dosing and is designed to assess the anti-tumor effect and safety of SIM0270 in combination with everolimus compared to the investigator’s choice of treatment. The trial is scheduled to enroll 460 ER+/HER2- local advanced or metastatic breast cancer patients who have been treated with a CDK4/6 inhibitor from 50 centers across China.
Preclinical and Phase I Data Support the Study’s Expansion
Preclinical research data on the next-generation small molecule SERD demonstrated high activity and high blood-brain barrier permeability, along with a good safety profile. This has been further supported by Phase I data, which showed SIM0270’s anti-tumor activity in advanced or metastatic ER+/HER2- breast cancer patients who had undergone multi-line treatments, along with good tolerability.-Fineline Info & Tech
