LEADS BIOLABS-B (09887) announced that its independently developed Vilixin (opatistumimab, an anti-PD-L1/4-1BB bispecific antibody) combined therapy for first-line treatment of locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma has completed the safety lead-in evaluation of its Phase II clinical trial, demonstrating positive efficacy signals that support advancing to the expansion stage.
With this milestone, Vilixin's clinical development in the field of gastrointestinal tumors now covers five major tumor types: biliary tract cancer (BTC), hepatocellular carcinoma (HCC), esophageal squamous cell carcinoma (ESCC), colorectal cancer (CRC), and gastric cancer (GC), with four of these studies having progressed to the expansion stage.
This study is led by Professor Shen Lin of Peking University Cancer Hospital and is being conducted simultaneously across multiple hospitals throughout China.
Based on the positive preliminary clinical data observed during the safety lead-in period, a comprehensive assessment by the sponsor and investigators supports advancing the study to the combination therapy expansion stage.
The expansion stage employs a randomized controlled trial design to directly compare the efficacy and safety of Vilixin combined with chemotherapy versus tislelizumab combined with chemotherapy as first-line treatment for locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma.
The study will also explore the correlation between biomarkers in tumor tissue and therapeutic efficacy to help define the patient population that would benefit from the combination regimen.
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