19 June 2023 | Monday | News
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The study is a multicenter, open-label, dose-escalation and expansion phase Ⅰ/Ⅱ clinical study. The phase Ⅰ part aims to evaluate the safety, tolerability, and pharmacokinetics of LBL-033 for the treatment of subjects with advanced malignancies, and to provide recommended doses for subsequent clinical studies. The primary objective of the Phase Ⅱ part is to evaluate the efficacy of LBL-033.
"I am pleased to see that the FDA has quickly approved the clinical trial application of LBL-033 in the United States, and I am grateful for the good suggestions given by the FDA during the IND review process. These have laid a good foundation for the rapid, high-quality and effective development of this new targeted immunotherapy." said Dr. Charles Cai, Chief Medical Officer of Leads Biolabs, "LBL-033 adopts a unique bispecific antibody molecule design to allow better drug aggregation in MUC16-overexpressing tumor cells and to reduce the non-specific activation of CD3, which may help improve efficacy and reduce side effects such as cytokine release syndrome. We look forward to the clinical evaluation of the safety and efficacy of this innovative drug in order to bring it to the general population of cancer patients as soon as possible."