Beijing Konruns Pharmaceutical Co.,Ltd. (603590.SH) has announced that its self-developed KC1036 tablets have received approval from the Center for Drug Evaluation (CDE) to initiate a pivotal Phase III clinical study. The trial is designed as a randomized, open-label, multicenter study to evaluate KC1036 versus investigator's choice of chemotherapy monotherapy for the treatment of advanced recurrent or metastatic thymic carcinoma in patients who have failed at least one prior platinum-based chemotherapy regimen.
KC1036 is a Class 1 innovative chemical drug entirely developed by the company, which holds global intellectual property rights for the product. The drug exerts its anti-tumor activity by inhibiting multiple targets including VEGFR2 and AXL. It demonstrates strong VEGFR vascular targeting properties that inhibit tumor cell growth, while its AXL inhibition helps enhance the host's anti-tumor immune response, thereby preventing tumor immune escape.
Currently, KC1036 is undergoing clinical investigations for multiple indications including digestive system tumors, thymic tumors, and pediatric Ewing's sarcoma. To date, more than 350 subjects have been enrolled in KC1036 clinical studies, with existing results demonstrating outstanding anti-tumor activity and safety profile. Phase II clinical results have shown that KC1036 exhibits remarkable anti-tumor efficacy with manageable safety in advanced recurrent or metastatic thymic carcinoma.
This recent CDE approval for the pivotal Phase III study in advanced thymic carcinoma marks the second indication for which KC1036 has received approval for critical Phase III clinical research, following its earlier Phase III trial approval for third-line treatment of advanced esophageal squamous cell carcinoma.
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