Beijing-based Konruns Pharmaceutical Co., Ltd (SHA: 603590) has announced the initiation of a single-arm, open, multi-center Phase II clinical study to assess the efficacy and safety of its Category 1 chemical drug KC1036 in patients with advanced thymoma and thymic carcinoma. The study focuses on patients whose disease has progressed after first-line systemic chemotherapy. The announcement was made online at www.chinadrugtrials.org.cn.
Clinical Profile of KC1036
KC1036 is a small molecule cancer therapy targeting AXL, VEGFR2, and FLT3. The drug received clinical trial approval in China in January 2020. A Phase I clinical study demonstrated that KC1036 has a favorable safety and tolerability profile, along with promising preliminary anti-tumor efficacy in multiple advanced solid tumors. As of the announcement date, over 100 patients with various advanced solid tumors have been enrolled in multiple studies, where KC1036 has shown good clinical safety and efficacy.
Phase II Study Details
Based on the positive preliminary efficacy results, Konruns has decided to proceed with a Phase II study for KC1036 in advanced thymic tumors. The study will be co-led by West China Hospital and Shanghai Chest Hospital, both of which are Class 3A hospitals in China. This Phase II study aims to further evaluate the therapeutic potential of KC1036 in this specific patient population.
Future Outlook
The initiation of the Phase II clinical trial for KC1036 in advanced thymoma and thymic carcinoma highlights Konruns Pharmaceutical’s commitment to advancing innovative cancer therapies. With demonstrated safety and efficacy in Phase I studies, KC1036 has the potential to address significant unmet needs in the treatment of advanced thymic tumors. Konruns’ ongoing clinical development efforts underscore its dedication to improving patient outcomes in oncology.-Fineline Info & Tech