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A Phase 1/2 Study of HLX301, A Recombinant Humanized Anti-PDL1 and Anti-TIGIT Bispecific Antibody, in Patients With Locally Advanced or Metastatic Solid Tumors
Shanghai Henlius Biotech
This study has three parts: phase 1a dose escalation, phase 1b dose expansion, and phase 2 clinical expansion. Phase 1 a is seeking to investigate the safety and determine the maximum tolerated dose (MTD) of HLX301. Six dose levels of 0.25mg/kg, 1mg/kg, 2.5mg/kg, 5mg/kg, 10mg/kg, and 15mg/kg are planned for dose finding. HLX301 will be administered as a single intravenous (IV) infusion on Day 1 in each 14-day cycle. Phase 1b will enrol participants with non-small cell lung cancer in two expansion cohorts at doses equal to or lower than the MTD to better understand the safety, tolerability and effectiveness of HLX301. HLX301 will be administered via IV infusion on Day 1 in each 14-day cycle. Phase 2 will further evaluate the effect of HLX301 in four cohorts of participants: non-small cell lung cancer with PD-L1 expression, gastric/oesophageal junction cancer with PD-L1 expression, head and neck squamous cell carcinoma with PD-L1 expression, and urothelial carcinoma with PD-L1 expression.