Core Viewpoint - The company has completed the first patient dosing in a Phase 1 clinical trial of HLX37, a dual-specific antibody targeting PD-L1 and VEGF, for advanced/metastatic solid tumors in mainland China [1][2] Group 1: Clinical Trial Details - The Phase 1 study is an open-label trial assessing the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of HLX37 in patients with advanced/metastatic solid tumors [1] - The trial consists of two parts: Part 1a involves dose escalation (including monotherapy and combination therapy) with six dose levels ranging from 1.0 mg/kg to 45.0 mg/kg administered every three weeks; Part 1b will expand based on results from Part 1a [1] - The primary endpoint is to evaluate the incidence of dose-limiting toxicities (DLT) to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) for both monotherapy and combination therapy [1] Group 2: Mechanism and Potential Benefits - HLX37 is designed to target two different pathways: it blocks the PD-1/PD-L1 signaling pathway to restore T-cell activity against tumors and inhibits VEGF to reduce tumor angiogenesis, potentially leading to synergistic anti-tumor effects and reduced risk of resistance [2] - Preclinical studies indicate that HLX37 can inhibit tumor growth and has a favorable safety profile [2] - The National Medical Products Administration (NMPA) approved the Phase 1 clinical trial application for HLX37 in November 2025 [2]
复宏汉霖(02696.HK)：HLX37在晚期/转移性实体瘤患者中的1期临床研究于中国大陆完成首例患者给药