Healthstar Medical Development Co., Ltd (SHA: 603590), based in Beijing, has received approval from China’s Center for Drug Evaluation (CDE) to commence a Phase III clinical study for its investigational drug candidate, KC1036. This randomized, controlled, open-label, multi-center Phase III trial aims to evaluate the efficacy and safety of KC1036 in patients with advanced recurrent or metastatic esophageal squamous cell carcinoma (ESCC) compared to chemotherapy selected by investigators.
KC1036 is a tyrosine kinase inhibitor (TKI) that targets AXL, VEGFR2, and FLT3, and is currently undergoing multiple clinical studies focusing on various digestive system tumors and thymic tumors. Preliminary clinical data highlights KC1036’s promising anti-tumor activity and safety profile. As of July 31, 2023, patients with advanced ESCC treated with KC1036 alone exhibited an overall response rate (ORR) of 26.1% and a disease control rate (DCR) of 69.6%, with a median overall survival of 7.1 months (95% CI: 4.2, NA).- Flcube.com
