Sichuan Biokin：BL-M14D1 initiates its first global Phase III trial.
On June 4 local time, the ClinicalTrials website showed that SystImmune, a wholly-owned subsidiary of Baili Tianheng, registered a Phase III clinical trial of BL-M14D1 in combination with Tecentriq
for the first-line treatment of extensive-stage small cell lung cancer. According to public information, this is the first Phase III trial initiated for this drug.
This is a global, open-label, multicenter Phase III clinical trial designed to evaluate the efficacy and safety of BL-M14D1 in combination with atezolizumab compared with standard treatment regimens in adult patients with previously untreated extensive-stage small cell lung cancer (ES-SCLC). The study plans to enroll approximately 550 patients, with the primary endpoint being progression-free survival (PFS).
BL-M14D1 is a novel DLL3-targeting ADC developed by Baili Tianheng. It precisely recognizes and binds to tumor cells, and upon internalization, releases a highly potent topoisomerase I inhibitor Ed-04 to achieve targeted killing. Baili Tianheng is also exploring the therapeutic potential of BL-M07D1 in small cell lung cancer (SCLC), neuroendocrine carcinoma (NEC), and other solid tumors.
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