Core Viewpoint - 基石药业-B (02616.HK) announced the latest clinical progress of CS2009, a potential first-in-class/traditional best PD-1/VEGF/CTLA-4 trispecific antibody, which aims to enhance efficacy while reducing systemic toxicity [1][2] Group 1: Clinical Development - CS2009 features balanced single-arm PD-1 and CTLA-4 binding arms along with a bivalent VEGFA binding arm, producing a strong multi-target synergistic effect [1] - The global multi-center I/II clinical study is actively recruiting patients in Australia and China, with plans to expand to the U.S. for Phase II enrollment, expecting to exceed 100 patients by the end of the year [1] Group 2: Safety and Efficacy - The Phase Ia dose-escalation study has completed assessments at four dose levels in heavily pre-treated advanced solid tumor patients, with the fourth dose level (20 mg/kg every three weeks) showing no dose-limiting toxicities (DLT) [2] - The study is currently enrolling patients at the fifth dose level (30 mg/kg every three weeks) to observe safety beyond the recommended Phase II dose (RP2D) and to broaden its safety profile [2] - CS2009 has demonstrated good tolerability across all evaluated dose levels, with pharmacokinetic (PK) characteristics supporting a three-week dosing regimen, and pharmacodynamic (PD) data confirming T-cell activation and anti-VEGFA neutralization [2]
基石药业-B(02616.HK)：CS2009(PD-1/VEGF/CTLA-4三特异性抗体)最新临床进展